List all clinical trials by discovery date. Accepts regular expressions in search.

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{
    "count": 4801,
    "next": "http://api.gregory-ms.com/trials/?format=api&page=70",
    "previous": "http://api.gregory-ms.com/trials/?format=api&page=68",
    "results": [
        {
            "trial_id": 3638,
            "title": "A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A",
            "summary": null,
            "published_date": "2008-06-25T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.824205Z",
            "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002096-27",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "euctr": "EUCTR2008-002096-27-PL"
            },
            "categories": [
                {
                    "category_id": 1,
                    "category_description": "Fingolimod, also known as Gilenya is a type of medicine known as a ‘disease-modifying therapy’ that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells. ‘Relapsing-remitting’ means that the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions). Gilenya is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly.\r\n\r\nhttps://www.ema.europa.eu/en/medicines/human/EPAR/gilenya",
                    "category_name": "Fingolimod",
                    "category_slug": "fingolimod",
                    "category_terms": [
                        "fingolimod",
                        "gilenya"
                    ],
                    "article_count": 257
                }
            ],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "2483843",
            "last_refreshed_on": "2012-03-19",
            "scientific_title": "A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A",
            "primary_sponsor": "Novartis Pharma Services AG",
            "retrospective_flag": "Yes",
            "date_registration": null,
            "source_register": "EU Clinical Trials Register",
            "recruitment_status": "Not Recruiting",
            "other_records": "Yes",
            "inclusion_agemin": null,
            "inclusion_agemax": null,
            "inclusion_gender": "<br>Female: yes<br>Male: yes<br>",
            "date_enrollement": "2008-10-09",
            "target_size": "1080",
            "study_type": "Interventional clinical trial of medicinal product",
            "study_design": "Controlled: yes\nRandomised: yes\nOpen: no\nSingle blind: no\nDouble blind: yes\nParallel group: yes\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no",
            "phase": null,
            "countries": "United Kingdom;Austria;Poland;Lithuania",
            "contact_firstname": null,
            "contact_lastname": null,
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": null,
            "inclusion_criteria": "Inclusion criteria: <br>General: <br>1. male or female females of childbearing potential must:<br>• have a negative pregnancy tests at Baseline prior to entry into the Double-Blind<br>Treatment Phase<br>• use simultaneously two forms of effective contraception (either partner) during the<br>treatment and for 3 months after discontinuation of the study medication females who are either post-menopausal for 12 months prior to Randomization or surgically sterile (through hysterectomy or bilateral oophorectomy) (if documented), are not required to use birth control. <br>2. 18 through 55 years of age inclusive<br>3. sign written informed consent prior to participating in the study <br><br>Multiple sclerosis:<br>4. diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria<br>5. a relapsing-remitting course with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years; prior to randomization<br>6. an Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive<br>7. neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization<br>8. Patients who explicitly decline initiation or continuation of treatment with available disease modifying drugs for whatever reason, after having been informed about their respective benefits and possible adverse events by the investigator.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br>",
            "exclusion_criteria": "Exclusion criteria: <br>1. a manifestation of MS other than RRMS<br>2. a history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome<br>3. a history or presence of malignancy (except for successfully treated basal or squamous cell carcinoma of skin)<br>4. a known or ‘new’ diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes [=126 mg/dL or =7 mmol/L if fasting; =200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus)<br>5. a diagnosis of macular edema during Pre-randomization Phase (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at the ophthalmic screening visit).<br>6. active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively<br>7. have received total lymphoid irradiation or bone marrow transplantation<br>8. have been treated with: (*)<br>9. any medically unstable condition, as assessed by the primary treating physician<br>10. any of the following cardiovascular conditions: (*)<br>11. any of the following pulmonary conditions: (*)<br>12. any of the following hepatic conditions: (*)<br>13. any of the following abnormal laboratory values: (*)<br>14. any of the following neurologic/psychiatric disorders: (*)<br>15. unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA<br>16. participation in any clinical research study evaluating another investigational drug or therapy within 6 months prior to randomization<br>17. history of fingolimod therapy<br><br>(*) Please see enclosed protocol section 5.1 for all details.<br><br>",
            "condition": "Relapsing-remitting multiple sclerosis. <br>MedDRA version: 13.1\nLevel: PT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis\nSystem Organ Class: 10029205 - Nervous system disorders",
            "intervention": "<br>Product Name: Fingolimod<br>Product Code: FTY720D<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: Fingolimod<br>CAS Number: 162359-56-0<br>Current Sponsor code: FTY720D<br>Other descriptive name: FTY720<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 0.5-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Product Name: Fingolimod<br>Product Code: FTY720D<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: Fingolimod<br>CAS Number: 162359-56-0<br>Current Sponsor code: FTY720D<br>Other descriptive name: FTY720<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 0.5-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>",
            "primary_outcome": "Main Objective: The primary objective is to  demonstrate that fingolimod 0.5 mg/day is superior to placebo as assessed by the annualized relapse rate (ARR) in patients with RRMS treated for up to 24 months.;Secondary Objective: 1. To evaluate the effect of fingolimod 0.5 mg/day relative to placebo on the percent change from baseline in brain atrophy in patients with RRMS treated for up to 24 months.<br>2. To evaluate the effect of fingolimod 0.5 mg/day relative to placebo on disability rogression as measured by the time to 3-month confirmed disability progression as measured by EDSS in patients with RRMS treated for up to 24 months.<br><br>Details of other secondary objectives see protocol track change.;Primary end point(s): The primary endpoint will be the annualized relapse rate (ARR), which is defined as the number of relapses in a year.",
            "secondary_outcome": null,
            "secondary_id": "CFTY720D2309",
            "source_support": null,
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3637,
            "title": "Lido Workset Study",
            "summary": null,
            "published_date": "2008-02-07T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.804710Z",
            "link": "https://clinicaltrials.gov/show/NCT00710645",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT00710645"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "6611865",
            "last_refreshed_on": "2017-12-16",
            "scientific_title": "Assessment of Spasticity in MS Patients Using a Lido Workset",
            "primary_sponsor": "University of California, Davis",
            "retrospective_flag": "No",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "18 Years",
            "inclusion_agemax": "N/A",
            "inclusion_gender": "All",
            "date_enrollement": "2003-04-28",
            "target_size": "31",
            "study_type": "Observational",
            "study_design": null,
            "phase": "N/A",
            "countries": "United States;United States;United States;United States;United States",
            "contact_firstname": "; ; ; ;",
            "contact_lastname": "Mark Agius, MD;Mark Agius, MD;Mark Agius, MD;Mark Agius, MD;Mark Agius, MD",
            "contact_address": null,
            "contact_email": ";;;;",
            "contact_tel": ";;;;",
            "contact_affiliation": "University of California, Davis;University of California, Davis;University of California, Davis;University of California, Davis;University of California, Davis",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Must have a diagnosis of multiple sclerosis and\r<br>\r<br>          -  Must have some degree of spasticity or\r<br>\r<br>          -  Must be a healthy control subject\r<br>\r<br>          -  Ability to give informed consent\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Patients with any life-threatening or unstable clinically significant disease\r<br>\r<br>          -  Patients with other causes of reduced range of motion of the knee or wrist\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Must have a diagnosis of multiple sclerosis and\r<br>\r<br>          -  Must have some degree of spasticity or\r<br>\r<br>          -  Must be a healthy control subject\r<br>\r<br>          -  Ability to give informed consent\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Patients with any life-threatening or unstable clinically significant disease\r<br>\r<br>          -  Patients with other causes of reduced range of motion of the knee or wrist\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Must have a diagnosis of multiple sclerosis and\r<br>\r<br>          -  Must have some degree of spasticity or\r<br>\r<br>          -  Must be a healthy control subject\r<br>\r<br>          -  Ability to give informed consent\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Patients with any life-threatening or unstable clinically significant disease\r<br>\r<br>          -  Patients with other causes of reduced range of motion of the knee or wrist\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Must have a diagnosis of multiple sclerosis and\r<br>\r<br>          -  Must have some degree of spasticity or\r<br>\r<br>          -  Must be a healthy control subject\r<br>\r<br>          -  Ability to give informed consent\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Patients with any life-threatening or unstable clinically significant disease\r<br>\r<br>          -  Patients with other causes of reduced range of motion of the knee or wrist\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis",
            "intervention": "Device: Lido Workset;Device: Lido Workset;Device: Lido Workset;Device: Lido Workset",
            "primary_outcome": "Assess measure of spasticity;Assess measure of spasticity;Assess measure of spasticity",
            "secondary_outcome": null,
            "secondary_id": "200310977",
            "source_support": "Please refer to primary and secondary sponsors",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3636,
            "title": "A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis.",
            "summary": null,
            "published_date": "2008-08-07T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.782173Z",
            "link": "https://clinicaltrials.gov/show/NCT00711646",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT00711646"
            },
            "categories": [
                {
                    "category_id": 18,
                    "category_description": "Search terms: telerehabilitation, physical therapy, virtual reality, gamification, neurostimulation, cognitive training, spasticity, motor control.\n\nSuggested by Alejandro Carrabs",
                    "category_name": "Physical therapy and Telerehabilitation",
                    "category_slug": "physical-therapy-and-telerehabilitation",
                    "category_terms": [
                        "telerehabilitation",
                        "physical therapy",
                        "virtual reality",
                        "gamification",
                        "neurostimulation",
                        "cognitive training",
                        "spasticity",
                        "motor control"
                    ],
                    "article_count": 174
                },
                {
                    "category_id": 45,
                    "category_description": "Sativex",
                    "category_name": "Sativex",
                    "category_slug": "sativex",
                    "category_terms": [
                        "nabiximols",
                        "sativex"
                    ],
                    "article_count": 27
                }
            ],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "6490669",
            "last_refreshed_on": "2017-10-19",
            "scientific_title": "A Double Blind, Randomised, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Cannabis Based Medicine 1:1 THC:CBD Compared With Placebo for the Treatment of Spasticity in Patients With Multiple Sclerosis.",
            "primary_sponsor": "GW Pharmaceuticals Ltd.",
            "retrospective_flag": "No",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "18 Years",
            "inclusion_agemax": "N/A",
            "inclusion_gender": "All",
            "date_enrollement": "2002-06-28",
            "target_size": "189",
            "study_type": "Interventional",
            "study_design": null,
            "phase": "Phase 3",
            "countries": "United Kingdom;United Kingdom;United Kingdom;United Kingdom",
            "contact_firstname": "; ; ;",
            "contact_lastname": "Christine Collin, MB BS MRCP FRCP;Christine Collin, MB BS MRCP FRCP;Christine Collin, MB BS MRCP FRCP;Christine Collin, MB BS MRCP FRCP",
            "contact_address": null,
            "contact_email": ";;;",
            "contact_tel": ";;;",
            "contact_affiliation": "Royal Berkshire Hospital;Royal Berkshire Hospital;Royal Berkshire Hospital;Royal Berkshire Hospital",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Willing and able to give informed consent.\r<br>\r<br>          -  Male or female, aged 18 years or above.\r<br>\r<br>          -  Stable disease for at least three months prior to study entry, in the opinion of the\r<br>             investigator.\r<br>\r<br>          -  Diagnosed with MS whose spasticity was not wholly relieved with the therapy at the\r<br>             time of study entry.\r<br>\r<br>          -  Significant spasticity in at least two muscle groups defined as a score of two or more\r<br>             on the Ashworth Scale for each muscle group.\r<br>\r<br>          -  Stable dose of current anti-spasticity medication for at least 30 days prior to study\r<br>             entry.\r<br>\r<br>          -  Willing to maintain a stable dose of anti-spasticity medication and level of\r<br>             physiotherapy for the duration of the study.\r<br>\r<br>          -  Clinically acceptable laboratory results at Visit 2.\r<br>\r<br>          -  Willing, if female and of child bearing potential or male subjects with a partner of\r<br>             child bearing potential, to ensure that effective contraception was used during the\r<br>             study and for three months thereafter.\r<br>\r<br>          -  No cannabinoid use (cannabis, Marinol® or Nabilone) for at least seven days before\r<br>             Visit 1 and were willing to abstain from any use of cannabis during the study.\r<br>\r<br>          -  Able (in the investigators opinion) and willing to comply with all study requirements.\r<br>\r<br>          -  Willing for the Home Office to be notified of his or her participation in the study\r<br>             (applicable to the UK centres only).\r<br>\r<br>          -  Willing to allow his or her GP and consultant, if appropriate, to be notified of\r<br>             participation in the study.\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  History of schizophrenia, other psychotic illness, severe personality disorder or\r<br>             other significant psychiatric disorder other than depression associated with their\r<br>             underlying condition.\r<br>\r<br>          -  Known history of alcohol or substance abuse.\r<br>\r<br>          -  Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias, poorly\r<br>             controlled hypertension or severe heart failure.\r<br>\r<br>          -  History of epilepsy.\r<br>\r<br>          -  Female subject who was pregnant, lactating or planning pregnancy during the course of\r<br>             the study.\r<br>\r<br>          -  Significant renal or hepatic impairment.\r<br>\r<br>          -  Scheduled elective surgery or other procedures requiring general anaesthesia during\r<br>             the study.\r<br>\r<br>          -  Subject who was terminally ill or was inappropriate for placebo medication.\r<br>\r<br>          -  Any other significant disease or disorder which, in the opinion of the investigator,\r<br>             either put the subject at risk because of participation in the study, or influenced\r<br>             the result of the study, or the subject's ability to participate in the study.\r<br>\r<br>          -  Regular levodopa (Sinemet®, Sinemet Plus®, Levodopa, L-dopa, Madopar®, Benserazide)\r<br>             therapy within seven days of study entry.\r<br>\r<br>          -  Male subject receiving sildenafil (Viagra®) and unwilling to stop medication for the\r<br>             duration of the study.\r<br>\r<br>          -  Subjects who were taking fentanyl (Durogesic®, Actiq®)\r<br>\r<br>          -  Subjects who were taking antiarrhythmic medications.\r<br>\r<br>          -  Known or suspected hypersensitivity to cannabinoids or any of the excipients of the\r<br>             study medications.\r<br>\r<br>          -  Known or suspected adverse reaction to cannabinoids.\r<br>\r<br>          -  Planned travel outside the UK during the study (applicable to the UK centres only).\r<br>\r<br>          -  Donation of blood during the study.\r<br>\r<br>          -  Subjects who had participated in another research study in the 12 weeks prior to study\r<br>             entry.\r<br>\r<br>          -  Subjects previously randomised into this study.\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Willing and able to give informed consent.\r<br>\r<br>          -  Male or female, aged 18 years or above.\r<br>\r<br>          -  Stable disease for at least three months prior to study entry, in the opinion of the\r<br>             investigator.\r<br>\r<br>          -  Diagnosed with MS whose spasticity was not wholly relieved with the therapy at the\r<br>             time of study entry.\r<br>\r<br>          -  Significant spasticity in at least two muscle groups defined as a score of two or more\r<br>             on the Ashworth Scale for each muscle group.\r<br>\r<br>          -  Stable dose of current anti-spasticity medication for at least 30 days prior to study\r<br>             entry.\r<br>\r<br>          -  Willing to maintain a stable dose of anti-spasticity medication and level of\r<br>             physiotherapy for the duration of the study.\r<br>\r<br>          -  Clinically acceptable laboratory results at Visit 2.\r<br>\r<br>          -  Willing, if female and of child bearing potential or male subjects with a partner of\r<br>             child bearing potential, to ensure that effective contraception was used during the\r<br>             study and for three months thereafter.\r<br>\r<br>          -  No cannabinoid use (cannabis, Marinol® or Nabilone) for at least seven days before\r<br>             Visit 1 and were willing to abstain from any use of cannabis during the study.\r<br>\r<br>          -  Able (in the investigators opinion) and willing to comply with all study requirements.\r<br>\r<br>          -  Willing for the Home Office to be notified of his or her participation in the study\r<br>             (applicable to the UK centres only).\r<br>\r<br>          -  Willing to allow his or her GP and consultant, if appropriate, to be notified of\r<br>             participation in the study.\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  History of schizophrenia, other psychotic illness, severe personality disorder or\r<br>             other significant psychiatric disorder other than depression associated with their\r<br>             underlying condition.\r<br>\r<br>          -  Known history of alcohol or substance abuse.\r<br>\r<br>          -  Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias, poorly\r<br>             controlled hypertension or severe heart failure.\r<br>\r<br>          -  History of epilepsy.\r<br>\r<br>          -  Female subject who was pregnant, lactating or planning pregnancy during the course of\r<br>             the study.\r<br>\r<br>          -  Significant renal or hepatic impairment.\r<br>\r<br>          -  Scheduled elective surgery or other procedures requiring general anaesthesia during\r<br>             the study.\r<br>\r<br>          -  Subject who was terminally ill or was inappropriate for placebo medication.\r<br>\r<br>          -  Any other significant disease or disorder which, in the opinion of the investigator,\r<br>             either put the subject at risk because of participation in the study, or influenced\r<br>             the result of the study, or the subject's ability to participate in the study.\r<br>\r<br>          -  Regular levodopa (Sinemet®, Sinemet Plus®, Levodopa, L-dopa, Madopar®, Benserazide)\r<br>             therapy within seven days of study entry.\r<br>\r<br>          -  Male subject receiving sildenafil (Viagra®) and unwilling to stop medication for the\r<br>             duration of the study.\r<br>\r<br>          -  Subjects who were taking fentanyl (Durogesic®, Actiq®)\r<br>\r<br>          -  Subjects who were taking antiarrhythmic medications.\r<br>\r<br>          -  Known or suspected hypersensitivity to cannabinoids or any of the excipients of the\r<br>             study medications.\r<br>\r<br>          -  Known or suspected adverse reaction to cannabinoids.\r<br>\r<br>          -  Planned travel outside the UK during the study (applicable to the UK centres only).\r<br>\r<br>          -  Donation of blood during the study.\r<br>\r<br>          -  Subjects who had participated in another research study in the 12 weeks prior to study\r<br>             entry.\r<br>\r<br>          -  Subjects previously randomised into this study.\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Willing and able to give informed consent.\r<br>\r<br>          -  Male or female, aged 18 years or above.\r<br>\r<br>          -  Stable disease for at least three months prior to study entry, in the opinion of the\r<br>             investigator.\r<br>\r<br>          -  Diagnosed with MS whose spasticity was not wholly relieved with the therapy at the\r<br>             time of study entry.\r<br>\r<br>          -  Significant spasticity in at least two muscle groups defined as a score of two or more\r<br>             on the Ashworth Scale for each muscle group.\r<br>\r<br>          -  Stable dose of current anti-spasticity medication for at least 30 days prior to study\r<br>             entry.\r<br>\r<br>          -  Willing to maintain a stable dose of anti-spasticity medication and level of\r<br>             physiotherapy for the duration of the study.\r<br>\r<br>          -  Clinically acceptable laboratory results at Visit 2.\r<br>\r<br>          -  Willing, if female and of child bearing potential or male subjects with a partner of\r<br>             child bearing potential, to ensure that effective contraception was used during the\r<br>             study and for three months thereafter.\r<br>\r<br>          -  No cannabinoid use (cannabis, Marinol® or Nabilone) for at least seven days before\r<br>             Visit 1 and were willing to abstain from any use of cannabis during the study.\r<br>\r<br>          -  Able (in the investigators opinion) and willing to comply with all study requirements.\r<br>\r<br>          -  Willing for the Home Office to be notified of his or her participation in the study\r<br>             (applicable to the UK centres only).\r<br>\r<br>          -  Willing to allow his or her GP and consultant, if appropriate, to be notified of\r<br>             participation in the study.\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  History of schizophrenia, other psychotic illness, severe personality disorder or\r<br>             other significant psychiatric disorder other than depression associated with their\r<br>             underlying condition.\r<br>\r<br>          -  Known history of alcohol or substance abuse.\r<br>\r<br>          -  Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias, poorly\r<br>             controlled hypertension or severe heart failure.\r<br>\r<br>          -  History of epilepsy.\r<br>\r<br>          -  Female subject who was pregnant, lactating or planning pregnancy during the course of\r<br>             the study.\r<br>\r<br>          -  Significant renal or hepatic impairment.\r<br>\r<br>          -  Scheduled elective surgery or other procedures requiring general anaesthesia during\r<br>             the study.\r<br>\r<br>          -  Subject who was terminally ill or was inappropriate for placebo medication.\r<br>\r<br>          -  Any other significant disease or disorder which, in the opinion of the investigator,\r<br>             either put the subject at risk because of participation in the study, or influenced\r<br>             the result of the study, or the subject's ability to participate in the study.\r<br>\r<br>          -  Regular levodopa (Sinemet®, Sinemet Plus®, Levodopa, L-dopa, Madopar®, Benserazide)\r<br>             therapy within seven days of study entry.\r<br>\r<br>          -  Male subject receiving sildenafil (Viagra®) and unwilling to stop medication for the\r<br>             duration of the study.\r<br>\r<br>          -  Subjects who were taking fentanyl (Durogesic®, Actiq®)\r<br>\r<br>          -  Subjects who were taking antiarrhythmic medications.\r<br>\r<br>          -  Known or suspected hypersensitivity to cannabinoids or any of the excipients of the\r<br>             study medications.\r<br>\r<br>          -  Known or suspected adverse reaction to cannabinoids.\r<br>\r<br>          -  Planned travel outside the UK during the study (applicable to the UK centres only).\r<br>\r<br>          -  Donation of blood during the study.\r<br>\r<br>          -  Subjects who had participated in another research study in the 12 weeks prior to study\r<br>             entry.\r<br>\r<br>          -  Subjects previously randomised into this study.\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Willing and able to give informed consent.\r<br>\r<br>          -  Male or female, aged 18 years or above.\r<br>\r<br>          -  Stable disease for at least three months prior to study entry, in the opinion of the\r<br>             investigator.\r<br>\r<br>          -  Diagnosed with MS whose spasticity was not wholly relieved with the therapy at the\r<br>             time of study entry.\r<br>\r<br>          -  Significant spasticity in at least two muscle groups defined as a score of two or more\r<br>             on the Ashworth Scale for each muscle group.\r<br>\r<br>          -  Stable dose of current anti-spasticity medication for at least 30 days prior to study\r<br>             entry.\r<br>\r<br>          -  Willing to maintain a stable dose of anti-spasticity medication and level of\r<br>             physiotherapy for the duration of the study.\r<br>\r<br>          -  Clinically acceptable laboratory results at Visit 2.\r<br>\r<br>          -  Willing, if female and of child bearing potential or male subjects with a partner of\r<br>             child bearing potential, to ensure that effective contraception was used during the\r<br>             study and for three months thereafter.\r<br>\r<br>          -  No cannabinoid use (cannabis, Marinol® or Nabilone) for at least seven days before\r<br>             Visit 1 and were willing to abstain from any use of cannabis during the study.\r<br>\r<br>          -  Able (in the investigators opinion) and willing to comply with all study requirements.\r<br>\r<br>          -  Willing for the Home Office to be notified of his or her participation in the study\r<br>             (applicable to the UK centres only).\r<br>\r<br>          -  Willing to allow his or her GP and consultant, if appropriate, to be notified of\r<br>             participation in the study.\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  History of schizophrenia, other psychotic illness, severe personality disorder or\r<br>             other significant psychiatric disorder other than depression associated with their\r<br>             underlying condition.\r<br>\r<br>          -  Known history of alcohol or substance abuse.\r<br>\r<br>          -  Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias, poorly\r<br>             controlled hypertension or severe heart failure.\r<br>\r<br>          -  History of epilepsy.\r<br>\r<br>          -  Female subject who was pregnant, lactating or planning pregnancy during the course of\r<br>             the study.\r<br>\r<br>          -  Significant renal or hepatic impairment.\r<br>\r<br>          -  Scheduled elective surgery or other procedures requiring general anaesthesia during\r<br>             the study.\r<br>\r<br>          -  Subject who was terminally ill or was inappropriate for placebo medication.\r<br>\r<br>          -  Any other significant disease or disorder which, in the opinion of the investigator,\r<br>             either put the subject at risk because of participation in the study, or influenced\r<br>             the result of the study, or the subject's ability to participate in the study.\r<br>\r<br>          -  Regular levodopa (Sinemet®, Sinemet Plus®, Levodopa, L-dopa, Madopar®, Benserazide)\r<br>             therapy within seven days of study entry.\r<br>\r<br>          -  Male subject receiving sildenafil (Viagra®) and unwilling to stop medication for the\r<br>             duration of the study.\r<br>\r<br>          -  Subjects who were taking fentanyl (Durogesic®, Actiq®)\r<br>\r<br>          -  Subjects who were taking antiarrhythmic medications.\r<br>\r<br>          -  Known or suspected hypersensitivity to cannabinoids or any of the excipients of the\r<br>             study medications.\r<br>\r<br>          -  Known or suspected adverse reaction to cannabinoids.\r<br>\r<br>          -  Planned travel outside the UK during the study (applicable to the UK centres only).\r<br>\r<br>          -  Donation of blood during the study.\r<br>\r<br>          -  Subjects who had participated in another research study in the 12 weeks prior to study\r<br>             entry.\r<br>\r<br>          -  Subjects previously randomised into this study.\r<br>",
            "exclusion_criteria": null,
            "condition": "Spasticity;Multiple Sclerosis;Spasticity;Multiple Sclerosis;Spasticity;Multiple Sclerosis;Spasticity;Multiple Sclerosis",
            "intervention": "Drug: Sativex®;Drug: Placebo;Drug: Sativex®;Drug: Placebo;Drug: Sativex®;Drug: Placebo;Drug: Sativex®;Drug: Placebo",
            "primary_outcome": "Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.;Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.",
            "secondary_outcome": "Change From Baseline in Mean Ashworth Scale Score at the End of Treatment;Change From Baseline in Mean Spasm Frequency Score at the End of Treatment;Change From Baseline in Mean Motricity Index Score for the Arms;Patient's Global Impression of Change in Condition at the End of Treatment;Incidence of Adverse Events as a Measure of Subject Safety;Change From Baseline in Mean Motricity Index Score for the Legs",
            "secondary_id": "GWMS0106",
            "source_support": "Please refer to primary and secondary sponsors",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3635,
            "title": "Cognitive Testing for the Pain Quality Assessment Scale (PQAS)",
            "summary": null,
            "published_date": "2008-11-07T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.762825Z",
            "link": "http://clinicaltrials.gov/show/NCT00715598",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT00715598"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "4644283",
            "last_refreshed_on": "2015-02-19",
            "scientific_title": "Cognitive Testing for the Pain Quality Assessment Scale (PQAS)",
            "primary_sponsor": "University of Washington",
            "retrospective_flag": "No",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "18 Years",
            "inclusion_agemax": "N/A",
            "inclusion_gender": "Both",
            "date_enrollement": "2008-06-28",
            "target_size": "213",
            "study_type": "Observational",
            "study_design": "Observational Model: Case Control, Time Perspective: Cross-Sectional",
            "phase": "N/A",
            "countries": "United States",
            "contact_firstname": "",
            "contact_lastname": "Mark P Jensen, Ph.D.",
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": "University of Washington",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Phase 1: have a primary pain problem caused either by musculoskeletal or neuropathic\r<br>             pain for SCI subjects,and neuropathic pain for subjects with MS.\r<br>\r<br>          -  have been diagnosed with an SCI or MS by a physician.\r<br>\r<br>          -  read, speak and understand English.\r<br>\r<br>          -  be at least 18 years of age.\r<br>\r<br>          -  experienced pain in the last three months prior to recruitment.\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>        -Individuals will be enrolled in the study if they meet all the eligibility criteria\r<br>        listed above; there are no particular exclusion criteria for this study.\r<br>",
            "exclusion_criteria": null,
            "condition": "Pain;Spinal Cord Injuries;Multiple Sclerosis",
            "intervention": null,
            "primary_outcome": "Pain Quality Assessment Scale (PQAS)",
            "secondary_outcome": null,
            "secondary_id": "33066-G",
            "source_support": "Please refer to primary and secondary sponsors",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3634,
            "title": "Amiloride Treatment in Multiple Sclerosis - Amiloride in MS",
            "summary": null,
            "published_date": "2008-07-15T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.727190Z",
            "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004051-11",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "euctr": "EUCTR2007-004051-11-GB"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "2468196",
            "last_refreshed_on": "2012-03-19",
            "scientific_title": "Amiloride Treatment in Multiple Sclerosis - Amiloride in MS",
            "primary_sponsor": "Oxford Racliffe NHS Trust",
            "retrospective_flag": "Yes",
            "date_registration": null,
            "source_register": "EU Clinical Trials Register",
            "recruitment_status": "Not Recruiting",
            "other_records": "No",
            "inclusion_agemin": null,
            "inclusion_agemax": null,
            "inclusion_gender": "<br>Female: yes<br>Male: yes<br>",
            "date_enrollement": "2008-12-18",
            "target_size": "23",
            "study_type": "Interventional clinical trial of medicinal product",
            "study_design": "Controlled: yes\nRandomised: \nOpen: yes\nSingle blind: \nDouble blind: \nParallel group: \nCross over: yes\nOther: \nIf controlled, specify comparator, Other Medicinial Product: \nPlacebo: \nOther: yes\nOther specify the comparator: Only those patients that have completed the Phase1 of the trial( no study drug) will be recruited",
            "phase": null,
            "countries": "United Kingdom",
            "contact_firstname": null,
            "contact_lastname": null,
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": null,
            "inclusion_criteria": "Inclusion criteria: <br>1.\tSubjects with primary progressive MS, who have completed the Phase I of the study which was performed over 52 weeks, when patients were not given any specific treatment.<br><br>2.\tWilling and able to comply with study visits according to protocol for the  <br>        full study period<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) <br>F.1.3.1 Number of subjects for this age range <br>",
            "exclusion_criteria": "Exclusion criteria: <br>11.\tAny immunosuppressive or immunomodulatory therapy received in the previous 12 months of the study.<br>2.\tCorticosteroids ( excluding topical or inhaled steroids) received in the previous three months.<br>3.\tHyperkalemia i.e; serum potassium levels ( greater than 5.5 mEq per litre)<br>4.\tPatients on potassium supplementation, patients receiving other potassium-conserving agents, such as spironolactone or triamterene. Potassium supplementation in the form of medication, potassium-containing salt substitutes or a potassium-rich diet.<br>5.\tImpaired renal function : Anuria, acute or chronic renal insufficiency and evidence of diabetic nephropathy <br>6.\tDiabetes mellitus.<br>7.\tHypersensitivity to amiloride hydrochloride or its ingredients.<br>8.\tOther serious illnesses or medical conditions such as cardiopulmonary disease.<br>9.\tPatient on angiotensin II receptor antagonist, angiotensin receptor blocker, cyclosporine and tacrolimus.<br>10.\tPregnant or breast feeding women, or patient/partner planning pregnancy within next 12months.<br>11.\tBlood urea nitrogen [BUN] levels over 30 mg per 100 mL or serum creatinine levels over 1.5 mg per 100 mL<br><br>",
            "condition": "Multiple Sclerosis",
            "intervention": "<br>Trade Name: Amiloride<br>Product Name: Amiloride Hydrochloride<br>Pharmaceutical Form: Coated tablet<br><br>",
            "primary_outcome": "Main Objective: The prinicipal aim of this study is to assess the efficacy of Amiloride on neurodegenerative change in multiple sclerosis.The primary outcome measure will be change in Magnetic resonance imaging markers studied over a period of 12 months.;Secondary Objective: The secondary research objective will be to assess Physician based EDSS and patient based MSIS-29. The overall mean change from baseline to end of study will be assessed.;Primary end point(s): MRI evidence of slowing of progression. However the study will terminate at 52 weeks after patients have been started on study drug",
            "secondary_outcome": null,
            "secondary_id": null,
            "source_support": null,
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3633,
            "title": "CDP323 Biomarker Study",
            "summary": null,
            "published_date": "2008-07-29T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.707258Z",
            "link": "http://clinicaltrials.gov/show/NCT00726648",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT00726648"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "4645118",
            "last_refreshed_on": "2015-02-19",
            "scientific_title": "Double-blind, Placebo-controlled, Randomized, Parallel-group Study in Subjects With Relapsing Forms of Multiple Sclerosis to Evaluate the Effects of Different CDP323 Doses on Biomarker Patterns as Well as on Safety and Tolerability.",
            "primary_sponsor": "UCB Pharma",
            "retrospective_flag": "No",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "18 Years",
            "inclusion_agemax": "65 Years",
            "inclusion_gender": "Both",
            "date_enrollement": "2008-07-28",
            "target_size": "71",
            "study_type": "Interventional",
            "study_design": "Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science",
            "phase": "Phase 1/Phase 2",
            "countries": "United Kingdom",
            "contact_firstname": "",
            "contact_lastname": "UCB Clinical Trial Call Center",
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": "UCB Pharma",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Female and male subjects aged 18-65 years\r<br>\r<br>          -  Relapsing form of MS with at least one clinical relapse in the 24 months before\r<br>             screening;\r<br>\r<br>          -  Screening EDSS score of 0-6.5;\r<br>\r<br>          -  Must be fully immunocompetent\r<br>\r<br>          -  Female subjects of childbearing potential must agree to practice contraception\r<br>             methods\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Any conditions that could interfere with the contrast-enhanced MRI;\r<br>\r<br>          -  Any clinically significant disease state or findings other than MS;\r<br>\r<br>          -  Any clinically significant deviation from the pre-defined ranges for laboratory\r<br>             tests;\r<br>\r<br>          -  Concomitant treatment with MS disease modifying drugs\r<br>",
            "exclusion_criteria": null,
            "condition": "Relapsing Multiple Sclerosis",
            "intervention": "Drug: CDP323;Drug: CDP323;Drug: CDP323;Drug: CDP323;Drug: Placebo",
            "primary_outcome": "Pharmacodynamic parameters related to leukocyte trafficking",
            "secondary_outcome": "Standard and disease-related safety variables;Class-related safety parameters",
            "secondary_id": "EudraCT 2008-000147-34;IND 74863;C32325",
            "source_support": "Please refer to primary and secondary sponsors",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3632,
            "title": "A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Duloxetine HCl in Patients with Central Neuropathic Pain Due to Multiple Sclerosis - HMFR",
            "summary": null,
            "published_date": "2008-07-29T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.685227Z",
            "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002560-34",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "euctr": "EUCTR2008-002560-34-BE"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "2471855",
            "last_refreshed_on": "2012-03-19",
            "scientific_title": "A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Duloxetine HCl in Patients with Central Neuropathic Pain Due to Multiple Sclerosis - HMFR",
            "primary_sponsor": "Eli Lilly and Company",
            "retrospective_flag": "Yes",
            "date_registration": null,
            "source_register": "EU Clinical Trials Register",
            "recruitment_status": "Not Recruiting",
            "other_records": "No",
            "inclusion_agemin": null,
            "inclusion_agemax": null,
            "inclusion_gender": "<br>Female: yes<br>Male: yes<br>",
            "date_enrollement": "2008-02-09",
            "target_size": "238",
            "study_type": "Interventional clinical trial of medicinal product",
            "study_design": "Controlled: yes\nRandomised: yes\nOpen: no\nSingle blind: no\nDouble blind: yes\nParallel group: yes\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no",
            "phase": null,
            "countries": "Belgium",
            "contact_firstname": null,
            "contact_lastname": null,
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": null,
            "inclusion_criteria": "Inclusion criteria: <br>[1] Present with central neuropathic pain due to MS based on the disease diagnostic criteria<br>[2] Are male or female outpatients at least 18 years of age at the time of consent<br>[3] Have a score of 4 or greater on the daily 24-hour average pain score (0-<br>10) for at least 4 of the 7 days prior to Visit 2<br>[4] Females must test negative for pregnancy at Visit 1. Females of childbearing potential must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study drug<br>[5] Have an educational level and degree of understanding such that the patient can communicate intelligibly<br>[6] Are judged to be reliable and agree to keep all appointments for clinic<br>visits, tests, and procedures required by the protocol<br>[7] Complete the daily diaries for at least 70% of the days between Visit 1 and Visit 2<br>[8] Patients may continue other prescription and non-prescription analgesic<br>medications as long as the dose has been stable for 1 month prior to<br>Visit 1, and they agree to maintain that stable dose throughout the study. Patients will NOT be allowed to change doses of concomitant analgesics<br>during the study<br>[9] Diagnosis of MS at least 1 year prior to Visit 1 as determined by MacDonald or Poser criteria.<br>[10] Clinical stability as determined by an absence of MS exacerbation or<br>change in disease modifying therapy for the 3 months prior to Visit 1.<br>[11] Daily central neuropathic pain due to MS present for a minimum of 3 months prior to Visit 1<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range <br>",
            "exclusion_criteria": "Exclusion criteria: <br>[12] Are investigator site personnel directly affiliated with this study and/or their immediate families<br>[13] Are Lilly employees<br>[14] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry<br>[15] Are currently in a clinical trial of MS disease-modifying therapy<br>[16] Have pain that cannot be clearly differentiated from causes other than MS<br>[17] Have previously completed this study, withdrawn from any duloxetine study, or have been intolerant to previous duloxetine treatment. Note: Patients who have screen-failed for the reason of previous exposure to duloxetine may be reconsidered for this study.<br>[18] Have previously demonstrated lack of response to an adequate trial of duloxetine per investigator opinion.<br>[19] Are unwilling to comply with the use of a data collection device to directly record data from the patient. For those patients who do not have enough fine motor control to enter data directly into the device, a designated assistant may be used for data entry. The assistant must be the same person for all data entries. The designated assistant may not be site personnel or personnel affiliated with the study.<br>[20] Any current or historical DSM-IV diagnosis  of mania, bipolar disorder, psychosis, or schizoaffective disorder<br>[21] History of DSM-IV-TR substance abuse or dependence within the 6<br>months immediately prior to Visit 1, excluding nicotine and caffeine. For purposes of this study, prior or current use (at Visit 1) of dronabinol (Saltivex) for MS or MS pain will not be considered to meet the DSm-IV criteria for substance abuse. However, use of this medication may be subject to other restrictions (see concomitant medication list for excluded medications).<br>[22] Are taking any excluded medications that cannot be discontinued at<br>Visit 1 (see concomitant medication list for excluded medications).<br>[23] Have had treatment with a MAOI within 14 days of randomization or<br>the potential need to use an MAOI during the study or within 5 days of<br>discontinuation of study drug<br>[24] Have a positive urine drug screen for any substance of abuse or excluded<br>medication<br>[25] Are pregnant or breast-feeding<br>[26] Have serious cardiovascular, hepatic, renal, respiratory, or hematologic<br>illness, or other medical or psychiatric condition that, in the opinion of<br>the investigator, would compromise participation or be likely to lead to<br>hospitalization during the course of the study.<br>[27] Have elective surgery planned during the trial.<br>[28] Have a history of recurrent seizures other than febrile seizures.<br>[29] Are judged clinically by the investigator or are identified by the C-SSRS or BDI-II question 9 to be at suicidal risk prior to starting study drug. Patients will need to be evaluated by the investigator and/or a psychiatrist if they exhibit suicidality as assessed by the C-SSRS or BDI-II question 9 at any time after randomization.<br>[30] Have uncontrolled narrow-angle glaucoma.<br>[31] Have acute liver injury or severe cirrhosis <br>[32] Have known hypersensitivity to duloxetine or any of the inactive ingredients<br>[33] Have frequent or severe allergic reactions to multiple medications<br>[34] Current DSM-IV-TR Axis I alcohol or eating disorders or PTSD as determined either by patient history or by diagnosis using specific modules of the MINI<br>",
            "condition": "Central neuropathic pain due to Multiple sclerosis <br>MedDRA version: 9.1\nLevel: LLT\nClassification code 10054095\nTerm: Neuropathic pain",
            "intervention": "<br>Trade Name: Cymbalta<br>Product Name: Duloxetine<br>Product Code: LY248686<br>Pharmaceutical Form: Gastro-resistant capsule, hard<br>INN or Proposed INN: DULOXETINE<br>CAS Number: 116539594<br>Current Sponsor code: LY248686<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 30-<br>Pharmaceutical form of the placebo: Gastro-resistant capsule, hard<br>Route of administration of the placebo: Oral use<br><br>",
            "primary_outcome": "Main Objective: to assess the efficacy of duloxetine 60 mg once daily (QD) compared with placebo on the reduction of central neuropathic pain severity as measured by the weekly mean of the daily 24-hour average pain scores in patients with central neuropathic pain due to MS assessed using an 11-point Likert scale and collected via daily patient diary at the end of 6 weeks of treatment.;Secondary Objective: • To evaluate response to treatment with duloxetine versus placebo using 2<br>response criteria, a 30% or 50% reduction, in the weekly 24-hour average pain scores described in the primary objective<br>• To assess the efficacy of duloxetine versus placebo as measured by:PGI-Improvement scale,the weekly mean of the 24-hour worst, least, and night pain scores assessed using an 11-point Likert scale and collected via daily patient diary,BPI– Severity and Interference,CGI-Severity<br>• To assess the impact of treatment with duloxetine versus<br>placebo on patient-reported health outcomes, as measured by the MS-QOL-54<br>• To assess the safety of duloxetine versus placebo treatment-emergent adverse events, discontinuation adverse events, solicited questioning of suicide-related events, and suicide risk as assessed the C-SSRS, laboratory assessments, and vital signs.;Primary end point(s): The primary efficacy measure is the weekly mean of the 24-hour average pain severity assessed daily by each patient, via daily diary, using an 11-point Likert scale.",
            "secondary_outcome": null,
            "secondary_id": "F1J-US-HMFR(b)",
            "source_support": null,
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3631,
            "title": "Oral Cladribine in Early Multiple Sclerosis (MS)",
            "summary": null,
            "published_date": "2008-07-30T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.659796Z",
            "link": "https://clinicaltrials.gov/show/NCT00725985",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT00725985"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "6612040",
            "last_refreshed_on": "2017-12-16",
            "scientific_title": "A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Oral Cladribine in Subjects With a First Clinical Event at High Risk of Converting to MS",
            "primary_sponsor": "EMD Serono",
            "retrospective_flag": "Yes",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "Yes",
            "inclusion_agemin": "18 Years",
            "inclusion_agemax": "55 Years",
            "inclusion_gender": "All",
            "date_enrollement": "2008-12-31",
            "target_size": "617",
            "study_type": "Interventional",
            "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).",
            "phase": "Phase 3",
            "countries": "United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;United States;Saudi Arabia;United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;United States;Saudi Arabia;United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;United States;Saudi Arabia;United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;United States;Saudi Arabia;United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;United States;Saudi Arabia",
            "contact_firstname": "; ; ; ;",
            "contact_lastname": "Bettina Stubinski, MD;Bettina Stubinski, MD;Bettina Stubinski, MD;Bettina Stubinski, MD;Bettina Stubinski, MD",
            "contact_address": null,
            "contact_email": ";;;;",
            "contact_tel": ";;;;",
            "contact_affiliation": "Merck Serono S.A., Geneva;Merck Serono S.A., Geneva;Merck Serono S.A., Geneva;Merck Serono S.A., Geneva;Merck Serono S.A., Geneva",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Male or female between 18 and 55 years old, inclusive\r<br>\r<br>          -  Weighed between 40 to 120 kilogram (kg), inclusive\r<br>\r<br>          -  Subject has experienced a single, first clinical event suggestive of MS within 75 days\r<br>             prior to the Screening visit, (clock starts 24 hours after onset). The event must be a\r<br>             new neurological abnormality present for at least 24 hours, either mono- or\r<br>             polysymptomatic\r<br>\r<br>          -  Subject has at least two clinically silent lesions on the T2-weighted MRI scan, at\r<br>             screening, with a size of at least 3 millimeter (mm), at least one of which is ovoid\r<br>             or periventricular or infratentorial on screening MRI\r<br>\r<br>          -  Subject has EDSS 0 - 5.0 at Screening\r<br>\r<br>          -  Subject has no medical history or evidence of latent tuberculosis infection (LTBI) or\r<br>             active tubercular disease, as evidenced by the Mantoux tuberculosis (TB) skin test or\r<br>             a comparable sensitive test according to local regulations/guidelines (if the Mantoux\r<br>             test is not available), and/or a chest X-ray\r<br>\r<br>          -  Subject has normal hematological parameters at Screening, as defined by the central\r<br>             laboratory that performed all the assessments\r<br>\r<br>          -  If female, she must:\r<br>\r<br>               -  be neither pregnant nor breast-feeding, nor attempting to conceive and\r<br>\r<br>               -  use a highly effective method of contraception throughout the entire duration of\r<br>                  the study and for 90 days following completion of the last dose of study\r<br>                  medication. A highly effective method of contraception is defined as those which\r<br>                  result in a low failure rate (that is less than 1 percent per year) when used\r<br>                  consistently and correctly such as implants, injectables, combined oral\r<br>                  contraceptives, some intrauterine devices, sexual abstinence or vasectomized\r<br>                  partner, or\r<br>\r<br>               -  be post-menopausal or surgically sterilized (Note: for Danish sites only,\r<br>                  subjects should use a hormonal contraceptive or intrauterine device for the\r<br>                  duration of the trial)\r<br>\r<br>          -  Male subjects must be willing to use contraception to avoid impregnating partners\r<br>             throughout the study, and for 90 days following the last dose of study medication\r<br>\r<br>          -  Be willing and able to comply with study procedures for the duration of the study\r<br>\r<br>          -  Subject has to provide written informed consent voluntarily, including, for United\r<br>             states of America (USA), subject authorization under Health Insurance Portability and\r<br>             Accountability Act (HIPAA), prior to any study-related procedure that is not part of\r<br>             normal medical care\r<br>\r<br>          -  Subject has refused any treatment already available for clinically isolated syndrome\r<br>             (CIS) such as interferons or glatiramer acetate, at the time of entry into the Initial\r<br>             Treatment Period of this study\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Subject has a diagnosis of MS (per McDonald criteria, 2005)\r<br>\r<br>          -  Subject has any other disease that could better explain the subject's signs and\r<br>             symptoms\r<br>\r<br>          -  Subject has complete transverse myelitis or bilateral optic neuritis\r<br>\r<br>          -  Subject using or has used any other approved MS disease modifying drug (DMD)\r<br>\r<br>          -  Subject has used any investigational drug or undergone an experimental procedure\r<br>             within 12 weeks prior to Study day 1\r<br>\r<br>          -  Subject received oral or systemic corticosteroids or adrenocorticotropic hormone\r<br>             (ACTH) within 30 days prior to screening MRI. The MRI had to be performed 30 days\r<br>             after the oral or systemic corticosteroids or ACTH treatment. In case this interfered\r<br>             with MRI timing the screening period could be extended accordingly.\r<br>\r<br>          -  Subject has abnormal total bilirubin, or aspartate aminotransferase (AST) or alanine\r<br>             aminotransferase (ALT) or alkaline phosphatase greater than 2.5 times the upper limit\r<br>             of normal\r<br>\r<br>          -  Subject suffered from current autoimmune disease other than MS\r<br>\r<br>          -  Subject suffered from psychiatric illness (including history of, or concurrent, severe\r<br>             depressive disorders and/or suicidal ideation) that in the opinion of the investigator\r<br>             creates undue risk to the subject or could affect compliance with the study protocol\r<br>\r<br>          -  Subject suffered from major medical illness such as cardiac (for example angina,\r<br>             congestive heart failure or arrhythmia), endocrinologic, hepatic, immunologic,\r<br>             metabolic, renal, pulmonary, gastrointestinal, dermatologic, or other major disease\r<br>             that would preclude the administration of oral cladribine\r<br>\r<br>          -  Subject has a history of seizures not adequately controlled by medications\r<br>\r<br>          -  Subject has a known allergy to cladribine, interferon-beta, the excipient(s) of the\r<br>             study medications, or to gadolinium- diethylenetriamine penta-acetic acid (DTPA)\r<br>\r<br>          -  Subject has any renal condition that would preclude the administration of gadolinium\r<br>             (for example acute or chronic severe renal insufficiency (glomerular filtration rate\r<br>             [GFR] less than 30 milliliter per minute per 1.73 square meter [mL/min/1.73 m^2])\r<br>\r<br>          -  Subject has a history of chronic or clinically significant hematological abnormalities\r<br>\r<br>          -  Subject has a history of active or chronic infectious disease or any disease that\r<br>             compromises immune function (for example human immunodeficiency virus positive [HIV+],\r<br>             human T-lymphotrophic virus [HTLV-1], Lyme disease, latent tuberculosis infection\r<br>             [LTBI] or TB, insulin-dependent diabetes).\r<br>\r<br>          -  Subject has previously been screened in this study (signed an informed consent) and\r<br>             then withdrawn\r<br>\r<br>          -  Subject has received any immunomodulatory or immunosuppressive therapy) at any time\r<br>             prior to Study Day 1, including, but not limited to, the following products: any\r<br>             interferon, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine,\r<br>             methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod,\r<br>             cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment\r<br>             (for example natalizumab, alemtuzumab/Campath, anti-cluster of differentiation 4\r<br>             [CD4]), intravenous immunoglobulin G (IVIG), cytokines or anti-cytokine therapy\r<br>\r<br>          -  Subject has received experimental MS treatment\r<br>\r<br>          -  Subject has a history of alcohol or drug abuse\r<br>\r<br>          -  Subject has intolerance or any contraindication to both paracetamol (acetaminophen)\r<br>             and ibuprofen\r<br>\r<br>          -  Subject has inability to administer subcutaneous injections either by self or by\r<br>             caregiver\r<br>\r<br>          -  Subject has prior or current malignancy (with the exception of in situ basal or\r<br>             squamous cell skin cancer surgically removed without recurrence for at least five\r<br>             years)\r<br>\r<br>          -  Subject has a positive stool hemoccult test at Screening\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Male or female between 18 and 55 years old, inclusive\r<br>\r<br>          -  Weighed between 40 to 120 kilogram (kg), inclusive\r<br>\r<br>          -  Subject has experienced a single, first clinical event suggestive of MS within 75 days\r<br>             prior to the Screening visit, (clock starts 24 hours after onset). The event must be a\r<br>             new neurological abnormality present for at least 24 hours, either mono- or\r<br>             polysymptomatic\r<br>\r<br>          -  Subject has at least two clinically silent lesions on the T2-weighted MRI scan, at\r<br>             screening, with a size of at least 3 millimeter (mm), at least one of which is ovoid\r<br>             or periventricular or infratentorial on screening MRI\r<br>\r<br>          -  Subject has EDSS 0 - 5.0 at Screening\r<br>\r<br>          -  Subject has no medical history or evidence of latent tuberculosis infection (LTBI) or\r<br>             active tubercular disease, as evidenced by the Mantoux tuberculosis (TB) skin test or\r<br>             a comparable sensitive test according to local regulations/guidelines (if the Mantoux\r<br>             test is not available), and/or a chest X-ray\r<br>\r<br>          -  Subject has normal hematological parameters at Screening, as defined by the central\r<br>             laboratory that performed all the assessments\r<br>\r<br>          -  If female, she must:\r<br>\r<br>               -  be neither pregnant nor breast-feeding, nor attempting to conceive and\r<br>\r<br>               -  use a highly effective method of contraception throughout the entire duration of\r<br>                  the study and for 90 days following completion of the last dose of study\r<br>                  medication. A highly effective method of contraception is defined as those which\r<br>                  result in a low failure rate (that is less than 1 percent per year) when used\r<br>                  consistently and correctly such as implants, injectables, combined oral\r<br>                  contraceptives, some intrauterine devices, sexual abstinence or vasectomized\r<br>                  partner, or\r<br>\r<br>               -  be post-menopausal or surgically sterilized (Note: for Danish sites only,\r<br>                  subjects should use a hormonal contraceptive or intrauterine device for the\r<br>                  duration of the trial)\r<br>\r<br>          -  Male subjects must be willing to use contraception to avoid impregnating partners\r<br>             throughout the study, and for 90 days following the last dose of study medication\r<br>\r<br>          -  Be willing and able to comply with study procedures for the duration of the study\r<br>\r<br>          -  Subject has to provide written informed consent voluntarily, including, for United\r<br>             states of America (USA), subject authorization under Health Insurance Portability and\r<br>             Accountability Act (HIPAA), prior to any study-related procedure that is not part of\r<br>             normal medical care\r<br>\r<br>          -  Subject has refused any treatment already available for clinically isolated syndrome\r<br>             (CIS) such as interferons or glatiramer acetate, at the time of entry into the Initial\r<br>             Treatment Period of this study\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Subject has a diagnosis of MS (per McDonald criteria, 2005)\r<br>\r<br>          -  Subject has any other disease that could better explain the subject's signs and\r<br>             symptoms\r<br>\r<br>          -  Subject has complete transverse myelitis or bilateral optic neuritis\r<br>\r<br>          -  Subject using or has used any other approved MS disease modifying drug (DMD)\r<br>\r<br>          -  Subject has used any investigational drug or undergone an experimental procedure\r<br>             within 12 weeks prior to Study day 1\r<br>\r<br>          -  Subject received oral or systemic corticosteroids or adrenocorticotropic hormone\r<br>             (ACTH) within 30 days prior to screening MRI. The MRI had to be performed 30 days\r<br>             after the oral or systemic corticosteroids or ACTH treatment. In case this interfered\r<br>             with MRI timing the screening period could be extended accordingly.\r<br>\r<br>          -  Subject has abnormal total bilirubin, or aspartate aminotransferase (AST) or alanine\r<br>             aminotransferase (ALT) or alkaline phosphatase greater than 2.5 times the upper limit\r<br>             of normal\r<br>\r<br>          -  Subject suffered from current autoimmune disease other than MS\r<br>\r<br>          -  Subject suffered from psychiatric illness (including history of, or concurrent, severe\r<br>             depressive disorders and/or suicidal ideation) that in the opinion of the investigator\r<br>             creates undue risk to the subject or could affect compliance with the study protocol\r<br>\r<br>          -  Subject suffered from major medical illness such as cardiac (for example angina,\r<br>             congestive heart failure or arrhythmia), endocrinologic, hepatic, immunologic,\r<br>             metabolic, renal, pulmonary, gastrointestinal, dermatologic, or other major disease\r<br>             that would preclude the administration of oral cladribine\r<br>\r<br>          -  Subject has a history of seizures not adequately controlled by medications\r<br>\r<br>          -  Subject has a known allergy to cladribine, interferon-beta, the excipient(s) of the\r<br>             study medications, or to gadolinium- diethylenetriamine penta-acetic acid (DTPA)\r<br>\r<br>          -  Subject has any renal condition that would preclude the administration of gadolinium\r<br>             (for example acute or chronic severe renal insufficiency (glomerular filtration rate\r<br>             [GFR] less than 30 milliliter per minute per 1.73 square meter [mL/min/1.73 m^2])\r<br>\r<br>          -  Subject has a history of chronic or clinically significant hematological abnormalities\r<br>\r<br>          -  Subject has a history of active or chronic infectious disease or any disease that\r<br>             compromises immune function (for example human immunodeficiency virus positive [HIV+],\r<br>             human T-lymphotrophic virus [HTLV-1], Lyme disease, latent tuberculosis infection\r<br>             [LTBI] or TB, insulin-dependent diabetes).\r<br>\r<br>          -  Subject has previously been screened in this study (signed an informed consent) and\r<br>             then withdrawn\r<br>\r<br>          -  Subject has received any immunomodulatory or immunosuppressive therapy) at any time\r<br>             prior to Study Day 1, including, but not limited to, the following products: any\r<br>             interferon, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine,\r<br>             methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod,\r<br>             cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment\r<br>             (for example natalizumab, alemtuzumab/Campath, anti-cluster of differentiation 4\r<br>             [CD4]), intravenous immunoglobulin G (IVIG), cytokines or anti-cytokine therapy\r<br>\r<br>          -  Subject has received experimental MS treatment\r<br>\r<br>          -  Subject has a history of alcohol or drug abuse\r<br>\r<br>          -  Subject has intolerance or any contraindication to both paracetamol (acetaminophen)\r<br>             and ibuprofen\r<br>\r<br>          -  Subject has inability to administer subcutaneous injections either by self or by\r<br>             caregiver\r<br>\r<br>          -  Subject has prior or current malignancy (with the exception of in situ basal or\r<br>             squamous cell skin cancer surgically removed without recurrence for at least five\r<br>             years)\r<br>\r<br>          -  Subject has a positive stool hemoccult test at Screening\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Male or female between 18 and 55 years old, inclusive\r<br>\r<br>          -  Weighed between 40 to 120 kilogram (kg), inclusive\r<br>\r<br>          -  Subject has experienced a single, first clinical event suggestive of MS within 75 days\r<br>             prior to the Screening visit, (clock starts 24 hours after onset). The event must be a\r<br>             new neurological abnormality present for at least 24 hours, either mono- or\r<br>             polysymptomatic\r<br>\r<br>          -  Subject has at least two clinically silent lesions on the T2-weighted MRI scan, at\r<br>             screening, with a size of at least 3 millimeter (mm), at least one of which is ovoid\r<br>             or periventricular or infratentorial on screening MRI\r<br>\r<br>          -  Subject has EDSS 0 - 5.0 at Screening\r<br>\r<br>          -  Subject has no medical history or evidence of latent tuberculosis infection (LTBI) or\r<br>             active tubercular disease, as evidenced by the Mantoux tuberculosis (TB) skin test or\r<br>             a comparable sensitive test according to local regulations/guidelines (if the Mantoux\r<br>             test is not available), and/or a chest X-ray\r<br>\r<br>          -  Subject has normal hematological parameters at Screening, as defined by the central\r<br>             laboratory that performed all the assessments\r<br>\r<br>          -  If female, she must:\r<br>\r<br>               -  be neither pregnant nor breast-feeding, nor attempting to conceive and\r<br>\r<br>               -  use a highly effective method of contraception throughout the entire duration of\r<br>                  the study and for 90 days following completion of the last dose of study\r<br>                  medication. A highly effective method of contraception is defined as those which\r<br>                  result in a low failure rate (that is less than 1 percent per year) when used\r<br>                  consistently and correctly such as implants, injectables, combined oral\r<br>                  contraceptives, some intrauterine devices, sexual abstinence or vasectomized\r<br>                  partner, or\r<br>\r<br>               -  be post-menopausal or surgically sterilized (Note: for Danish sites only,\r<br>                  subjects should use a hormonal contraceptive or intrauterine device for the\r<br>                  duration of the trial)\r<br>\r<br>          -  Male subjects must be willing to use contraception to avoid impregnating partners\r<br>             throughout the study, and for 90 days following the last dose of study medication\r<br>\r<br>          -  Be willing and able to comply with study procedures for the duration of the study\r<br>\r<br>          -  Subject has to provide written informed consent voluntarily, including, for United\r<br>             states of America (USA), subject authorization under Health Insurance Portability and\r<br>             Accountability Act (HIPAA), prior to any study-related procedure that is not part of\r<br>             normal medical care\r<br>\r<br>          -  Subject has refused any treatment already available for clinically isolated syndrome\r<br>             (CIS) such as interferons or glatiramer acetate, at the time of entry into the Initial\r<br>             Treatment Period of this study\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Subject has a diagnosis of MS (per McDonald criteria, 2005)\r<br>\r<br>          -  Subject has any other disease that could better explain the subject's signs and\r<br>             symptoms\r<br>\r<br>          -  Subject has complete transverse myelitis or bilateral optic neuritis\r<br>\r<br>          -  Subject using or has used any other approved MS disease modifying drug (DMD)\r<br>\r<br>          -  Subject has used any investigational drug or undergone an experimental procedure\r<br>             within 12 weeks prior to Study day 1\r<br>\r<br>          -  Subject received oral or systemic corticosteroids or adrenocorticotropic hormone\r<br>             (ACTH) within 30 days prior to screening MRI. The MRI had to be performed 30 days\r<br>             after the oral or systemic corticosteroids or ACTH treatment. In case this interfered\r<br>             with MRI timing the screening period could be extended accordingly.\r<br>\r<br>          -  Subject has abnormal total bilirubin, or aspartate aminotransferase (AST) or alanine\r<br>             aminotransferase (ALT) or alkaline phosphatase greater than 2.5 times the upper limit\r<br>             of normal\r<br>\r<br>          -  Subject suffered from current autoimmune disease other than MS\r<br>\r<br>          -  Subject suffered from psychiatric illness (including history of, or concurrent, severe\r<br>             depressive disorders and/or suicidal ideation) that in the opinion of the investigator\r<br>             creates undue risk to the subject or could affect compliance with the study protocol\r<br>\r<br>          -  Subject suffered from major medical illness such as cardiac (for example angina,\r<br>             congestive heart failure or arrhythmia), endocrinologic, hepatic, immunologic,\r<br>             metabolic, renal, pulmonary, gastrointestinal, dermatologic, or other major disease\r<br>             that would preclude the administration of oral cladribine\r<br>\r<br>          -  Subject has a history of seizures not adequately controlled by medications\r<br>\r<br>          -  Subject has a known allergy to cladribine, interferon-beta, the excipient(s) of the\r<br>             study medications, or to gadolinium- diethylenetriamine penta-acetic acid (DTPA)\r<br>\r<br>          -  Subject has any renal condition that would preclude the administration of gadolinium\r<br>             (for example acute or chronic severe renal insufficiency (glomerular filtration rate\r<br>             [GFR] less than 30 milliliter per minute per 1.73 square meter [mL/min/1.73 m^2])\r<br>\r<br>          -  Subject has a history of chronic or clinically significant hematological abnormalities\r<br>\r<br>          -  Subject has a history of active or chronic infectious disease or any disease that\r<br>             compromises immune function (for example human immunodeficiency virus positive [HIV+],\r<br>             human T-lymphotrophic virus [HTLV-1], Lyme disease, latent tuberculosis infection\r<br>             [LTBI] or TB, insulin-dependent diabetes).\r<br>\r<br>          -  Subject has previously been screened in this study (signed an informed consent) and\r<br>             then withdrawn\r<br>\r<br>          -  Subject has received any immunomodulatory or immunosuppressive therapy) at any time\r<br>             prior to Study Day 1, including, but not limited to, the following products: any\r<br>             interferon, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine,\r<br>             methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod,\r<br>             cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment\r<br>             (for example natalizumab, alemtuzumab/Campath, anti-cluster of differentiation 4\r<br>             [CD4]), intravenous immunoglobulin G (IVIG), cytokines or anti-cytokine therapy\r<br>\r<br>          -  Subject has received experimental MS treatment\r<br>\r<br>          -  Subject has a history of alcohol or drug abuse\r<br>\r<br>          -  Subject has intolerance or any contraindication to both paracetamol (acetaminophen)\r<br>             and ibuprofen\r<br>\r<br>          -  Subject has inability to administer subcutaneous injections either by self or by\r<br>             caregiver\r<br>\r<br>          -  Subject has prior or current malignancy (with the exception of in situ basal or\r<br>             squamous cell skin cancer surgically removed without recurrence for at least five\r<br>             years)\r<br>\r<br>          -  Subject has a positive stool hemoccult test at Screening\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Male or female between 18 and 55 years old, inclusive\r<br>\r<br>          -  Weighed between 40 to 120 kilogram (kg), inclusive\r<br>\r<br>          -  Subject has experienced a single, first clinical event suggestive of MS within 75 days\r<br>             prior to the Screening visit, (clock starts 24 hours after onset). The event must be a\r<br>             new neurological abnormality present for at least 24 hours, either mono- or\r<br>             polysymptomatic\r<br>\r<br>          -  Subject has at least two clinically silent lesions on the T2-weighted MRI scan, at\r<br>             screening, with a size of at least 3 millimeter (mm), at least one of which is ovoid\r<br>             or periventricular or infratentorial on screening MRI\r<br>\r<br>          -  Subject has EDSS 0 - 5.0 at Screening\r<br>\r<br>          -  Subject has no medical history or evidence of latent tuberculosis infection (LTBI) or\r<br>             active tubercular disease, as evidenced by the Mantoux tuberculosis (TB) skin test or\r<br>             a comparable sensitive test according to local regulations/guidelines (if the Mantoux\r<br>             test is not available), and/or a chest X-ray\r<br>\r<br>          -  Subject has normal hematological parameters at Screening, as defined by the central\r<br>             laboratory that performed all the assessments\r<br>\r<br>          -  If female, she must:\r<br>\r<br>               -  be neither pregnant nor breast-feeding, nor attempting to conceive and\r<br>\r<br>               -  use a highly effective method of contraception throughout the entire duration of\r<br>                  the study and for 90 days following completion of the last dose of study\r<br>                  medication. A highly effective method of contraception is defined as those which\r<br>                  result in a low failure rate (that is less than 1 percent per year) when used\r<br>                  consistently and correctly such as implants, injectables, combined oral\r<br>                  contraceptives, some intrauterine devices, sexual abstinence or vasectomized\r<br>                  partner, or\r<br>\r<br>               -  be post-menopausal or surgically sterilized (Note: for Danish sites only,\r<br>                  subjects should use a hormonal contraceptive or intrauterine device for the\r<br>                  duration of the trial)\r<br>\r<br>          -  Male subjects must be willing to use contraception to avoid impregnating partners\r<br>             throughout the study, and for 90 days following the last dose of study medication\r<br>\r<br>          -  Be willing and able to comply with study procedures for the duration of the study\r<br>\r<br>          -  Subject has to provide written informed consent voluntarily, including, for United\r<br>             states of America (USA), subject authorization under Health Insurance Portability and\r<br>             Accountability Act (HIPAA), prior to any study-related procedure that is not part of\r<br>             normal medical care\r<br>\r<br>          -  Subject has refused any treatment already available for clinically isolated syndrome\r<br>             (CIS) such as interferons or glatiramer acetate, at the time of entry into the Initial\r<br>             Treatment Period of this study\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Subject has a diagnosis of MS (per McDonald criteria, 2005)\r<br>\r<br>          -  Subject has any other disease that could better explain the subject's signs and\r<br>             symptoms\r<br>\r<br>          -  Subject has complete transverse myelitis or bilateral optic neuritis\r<br>\r<br>          -  Subject using or has used any other approved MS disease modifying drug (DMD)\r<br>\r<br>          -  Subject has used any investigational drug or undergone an experimental procedure\r<br>             within 12 weeks prior to Study day 1\r<br>\r<br>          -  Subject received oral or systemic corticosteroids or adrenocorticotropic hormone\r<br>             (ACTH) within 30 days prior to screening MRI. The MRI had to be performed 30 days\r<br>             after the oral or systemic corticosteroids or ACTH treatment. In case this interfered\r<br>             with MRI timing the screening period could be extended accordingly.\r<br>\r<br>          -  Subject has abnormal total bilirubin, or aspartate aminotransferase (AST) or alanine\r<br>             aminotransferase (ALT) or alkaline phosphatase greater than 2.5 times the upper limit\r<br>             of normal\r<br>\r<br>          -  Subject suffered from current autoimmune disease other than MS\r<br>\r<br>          -  Subject suffered from psychiatric illness (including history of, or concurrent, severe\r<br>             depressive disorders and/or suicidal ideation) that in the opinion of the investigator\r<br>             creates undue risk to the subject or could affect compliance with the study protocol\r<br>\r<br>          -  Subject suffered from major medical illness such as cardiac (for example angina,\r<br>             congestive heart failure or arrhythmia), endocrinologic, hepatic, immunologic,\r<br>             metabolic, renal, pulmonary, gastrointestinal, dermatologic, or other major disease\r<br>             that would preclude the administration of oral cladribine\r<br>\r<br>          -  Subject has a history of seizures not adequately controlled by medications\r<br>\r<br>          -  Subject has a known allergy to cladribine, interferon-beta, the excipient(s) of the\r<br>             study medications, or to gadolinium- diethylenetriamine penta-acetic acid (DTPA)\r<br>\r<br>          -  Subject has any renal condition that would preclude the administration of gadolinium\r<br>             (for example acute or chronic severe renal insufficiency (glomerular filtration rate\r<br>             [GFR] less than 30 milliliter per minute per 1.73 square meter [mL/min/1.73 m^2])\r<br>\r<br>          -  Subject has a history of chronic or clinically significant hematological abnormalities\r<br>\r<br>          -  Subject has a history of active or chronic infectious disease or any disease that\r<br>             compromises immune function (for example human immunodeficiency virus positive [HIV+],\r<br>             human T-lymphotrophic virus [HTLV-1], Lyme disease, latent tuberculosis infection\r<br>             [LTBI] or TB, insulin-dependent diabetes).\r<br>\r<br>          -  Subject has previously been screened in this study (signed an informed consent) and\r<br>             then withdrawn\r<br>\r<br>          -  Subject has received any immunomodulatory or immunosuppressive therapy) at any time\r<br>             prior to Study Day 1, including, but not limited to, the following products: any\r<br>             interferon, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine,\r<br>             methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod,\r<br>             cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment\r<br>             (for example natalizumab, alemtuzumab/Campath, anti-cluster of differentiation 4\r<br>             [CD4]), intravenous immunoglobulin G (IVIG), cytokines or anti-cytokine therapy\r<br>\r<br>          -  Subject has received experimental MS treatment\r<br>\r<br>          -  Subject has a history of alcohol or drug abuse\r<br>\r<br>          -  Subject has intolerance or any contraindication to both paracetamol (acetaminophen)\r<br>             and ibuprofen\r<br>\r<br>          -  Subject has inability to administer subcutaneous injections either by self or by\r<br>             caregiver\r<br>\r<br>          -  Subject has prior or current malignancy (with the exception of in situ basal or\r<br>             squamous cell skin cancer surgically removed without recurrence for at least five\r<br>             years)\r<br>\r<br>          -  Subject has a positive stool hemoccult test at Screening\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis",
            "intervention": "Drug: Cladribine;Drug: Cladribine;Drug: Placebo;Drug: Rebif® new formulation (RNF);Drug: Cladribine;Drug: Cladribine;Drug: Placebo;Drug: Rebif® new formulation (RNF);Drug: Cladribine;Drug: Cladribine;Drug: Placebo;Drug: Rebif® new formulation (RNF);Drug: Cladribine;Drug: Cladribine;Drug: Placebo;Drug: Rebif® new formulation (RNF)",
            "primary_outcome": "Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS;Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS;Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS",
            "secondary_outcome": "Time to Develop Multiple Sclerosis (MS) Conversion According to the Revised McDonald Criteria (2005) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With McDonald MS;Number of Combined Unique Active (CUA) Lesions, New or Enlarging Time Constant 2 (T2) Lesions, and New or Persisting Time Constant 1 (T1) Gadolinium Enhanced (Gd+) Lesions Per Participant Per Scan;Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)",
            "secondary_id": "28821",
            "source_support": "Please refer to primary and secondary sponsors",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3630,
            "title": "12-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis.",
            "summary": null,
            "published_date": "2008-12-08T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.622725Z",
            "link": "https://clinicaltrials.gov/show/NCT00735007",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT00735007"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "6491118",
            "last_refreshed_on": "2017-10-19",
            "scientific_title": "International, Multicenter, Single-arm, Open-label, 12-week Phase IIIb Study to Evaluate RebiSmart™ Suitability for Self Injection of Rebif® New Formulation (RNF) in Multidose Cartridges in Patients With Relapsing Form of Multiple Sclerosis (RMS)",
            "primary_sponsor": "EMD Serono",
            "retrospective_flag": "No",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "18 Years",
            "inclusion_agemax": "65 Years",
            "inclusion_gender": "All",
            "date_enrollement": "2008-07-28",
            "target_size": "106",
            "study_type": "Interventional",
            "study_design": null,
            "phase": "Phase 3",
            "countries": "United States;Canada;Germany;Italy;Spain;Sweden;Canada;Germany;Italy;Spain;Sweden;United States;United States;Canada;Germany;Italy;Spain;Sweden;Canada;Germany;Italy;Spain;Sweden;United States;United States;Canada;Germany;Italy;Spain;Sweden;Canada;Germany;Italy;Spain;Sweden;United States;United States;Canada;Germany;Italy;Spain;Sweden;Canada;Germany;Italy;Spain;Sweden;United States",
            "contact_firstname": "; ; ;",
            "contact_lastname": "Elisabetta Verdun di Cantogno, MD;Elisabetta Verdun di Cantogno, MD;Elisabetta Verdun di Cantogno, MD;Elisabetta Verdun di Cantogno, MD",
            "contact_address": null,
            "contact_email": ";;;",
            "contact_tel": ";;;",
            "contact_affiliation": "Merck Serono International, S.A., an affiliate of Merck KGaA, Darmstadt, Germany;Merck Serono International, S.A., an affiliate of Merck KGaA, Darmstadt, Germany;Merck Serono International, S.A., an affiliate of Merck KGaA, Darmstadt, Germany;Merck Serono International, S.A., an affiliate of Merck KGaA, Darmstadt, Germany",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Males and females between 18 and 65 years of age, inclusive\r<br>\r<br>          -  Female subjects must be neither pregnant nor breast-feeding and must lack\r<br>             child-bearing potential, as defined by either:\r<br>\r<br>               -  Post-menopausal or surgically sterile, or\r<br>\r<br>               -  Using a highly effective method of contraception for the duration of the study.\r<br>                  This is defined as a method that result in a low failure rate (i.e., less than 1%\r<br>                  per year) when used consistently and correctly, and includes for instance\r<br>                  implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s,\r<br>                  sexual abstinence or vasectomised partner.\r<br>\r<br>          -  Have RMS according to the revised McDonald Criteria 2005\r<br>\r<br>          -  Have disease duration for at least 3 months\r<br>\r<br>          -  Are currently receiving RNF 44 mcg sc by Rebiject IITM (RII) tiw and have been\r<br>             consistently on therapy for a minimum of 6 weeks prior to Screening\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Have any disease other than MS that could better explain his/her signs and symptoms\r<br>\r<br>          -  Receive any other injectable medications on a regular basis during the week prior to\r<br>             the screening period or throughout the duration of the study. The administration of a\r<br>             single injection for treatment or prophylaxis of a condition unrelated to the\r<br>             patient's MS or the patient's RNF therapy (e.g., influenza or pneumococcus\r<br>             vaccination) will be acceptable\r<br>\r<br>          -  Receive any MS therapy other than Rebif / RNF (e.g., other disease-modifying drug\r<br>             [DMD]s: immunomodulatory , immunosuppressive agents or combination therapy) within 12\r<br>             months prior to study enrolment or at any time during the study\r<br>\r<br>          -  Receive oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within\r<br>             30 days prior to SD1\r<br>\r<br>          -  Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 3 x\r<br>             upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2\r<br>             x ULN if associated with any elevation of ALT or alkaline phosphatase\r<br>\r<br>          -  Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5\r<br>             x lower limit of normal\r<br>\r<br>          -  Have moderate to severe renal impairment\r<br>\r<br>          -  History of any chronic pain syndrome\r<br>\r<br>          -  Any visual or physical impairment that precludes the subject self-injecting the\r<br>             treatment using the RebiSmartä\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Males and females between 18 and 65 years of age, inclusive\r<br>\r<br>          -  Female subjects must be neither pregnant nor breast-feeding and must lack\r<br>             child-bearing potential, as defined by either:\r<br>\r<br>               -  Post-menopausal or surgically sterile, or\r<br>\r<br>               -  Using a highly effective method of contraception for the duration of the study.\r<br>                  This is defined as a method that result in a low failure rate (i.e., less than 1%\r<br>                  per year) when used consistently and correctly, and includes for instance\r<br>                  implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s,\r<br>                  sexual abstinence or vasectomised partner.\r<br>\r<br>          -  Have RMS according to the revised McDonald Criteria 2005\r<br>\r<br>          -  Have disease duration for at least 3 months\r<br>\r<br>          -  Are currently receiving RNF 44 mcg sc by Rebiject IITM (RII) tiw and have been\r<br>             consistently on therapy for a minimum of 6 weeks prior to Screening\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Have any disease other than MS that could better explain his/her signs and symptoms\r<br>\r<br>          -  Receive any other injectable medications on a regular basis during the week prior to\r<br>             the screening period or throughout the duration of the study. The administration of a\r<br>             single injection for treatment or prophylaxis of a condition unrelated to the\r<br>             patient's MS or the patient's RNF therapy (e.g., influenza or pneumococcus\r<br>             vaccination) will be acceptable\r<br>\r<br>          -  Receive any MS therapy other than Rebif / RNF (e.g., other disease-modifying drug\r<br>             [DMD]s: immunomodulatory , immunosuppressive agents or combination therapy) within 12\r<br>             months prior to study enrolment or at any time during the study\r<br>\r<br>          -  Receive oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within\r<br>             30 days prior to SD1\r<br>\r<br>          -  Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 3 x\r<br>             upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2\r<br>             x ULN if associated with any elevation of ALT or alkaline phosphatase\r<br>\r<br>          -  Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5\r<br>             x lower limit of normal\r<br>\r<br>          -  Have moderate to severe renal impairment\r<br>\r<br>          -  History of any chronic pain syndrome\r<br>\r<br>          -  Any visual or physical impairment that precludes the subject self-injecting the\r<br>             treatment using the RebiSmartä\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Males and females between 18 and 65 years of age, inclusive\r<br>\r<br>          -  Female subjects must be neither pregnant nor breast-feeding and must lack\r<br>             child-bearing potential, as defined by either:\r<br>\r<br>               -  Post-menopausal or surgically sterile, or\r<br>\r<br>               -  Using a highly effective method of contraception for the duration of the study.\r<br>                  This is defined as a method that result in a low failure rate (i.e., less than 1%\r<br>                  per year) when used consistently and correctly, and includes for instance\r<br>                  implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s,\r<br>                  sexual abstinence or vasectomised partner.\r<br>\r<br>          -  Have RMS according to the revised McDonald Criteria 2005\r<br>\r<br>          -  Have disease duration for at least 3 months\r<br>\r<br>          -  Are currently receiving RNF 44 mcg sc by Rebiject IITM (RII) tiw and have been\r<br>             consistently on therapy for a minimum of 6 weeks prior to Screening\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Have any disease other than MS that could better explain his/her signs and symptoms\r<br>\r<br>          -  Receive any other injectable medications on a regular basis during the week prior to\r<br>             the screening period or throughout the duration of the study. The administration of a\r<br>             single injection for treatment or prophylaxis of a condition unrelated to the\r<br>             patient's MS or the patient's RNF therapy (e.g., influenza or pneumococcus\r<br>             vaccination) will be acceptable\r<br>\r<br>          -  Receive any MS therapy other than Rebif / RNF (e.g., other disease-modifying drug\r<br>             [DMD]s: immunomodulatory , immunosuppressive agents or combination therapy) within 12\r<br>             months prior to study enrolment or at any time during the study\r<br>\r<br>          -  Receive oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within\r<br>             30 days prior to SD1\r<br>\r<br>          -  Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 3 x\r<br>             upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2\r<br>             x ULN if associated with any elevation of ALT or alkaline phosphatase\r<br>\r<br>          -  Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5\r<br>             x lower limit of normal\r<br>\r<br>          -  Have moderate to severe renal impairment\r<br>\r<br>          -  History of any chronic pain syndrome\r<br>\r<br>          -  Any visual or physical impairment that precludes the subject self-injecting the\r<br>             treatment using the RebiSmartä\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Males and females between 18 and 65 years of age, inclusive\r<br>\r<br>          -  Female subjects must be neither pregnant nor breast-feeding and must lack\r<br>             child-bearing potential, as defined by either:\r<br>\r<br>               -  Post-menopausal or surgically sterile, or\r<br>\r<br>               -  Using a highly effective method of contraception for the duration of the study.\r<br>                  This is defined as a method that result in a low failure rate (i.e., less than 1%\r<br>                  per year) when used consistently and correctly, and includes for instance\r<br>                  implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s,\r<br>                  sexual abstinence or vasectomised partner.\r<br>\r<br>          -  Have RMS according to the revised McDonald Criteria 2005\r<br>\r<br>          -  Have disease duration for at least 3 months\r<br>\r<br>          -  Are currently receiving RNF 44 mcg sc by Rebiject IITM (RII) tiw and have been\r<br>             consistently on therapy for a minimum of 6 weeks prior to Screening\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Have any disease other than MS that could better explain his/her signs and symptoms\r<br>\r<br>          -  Receive any other injectable medications on a regular basis during the week prior to\r<br>             the screening period or throughout the duration of the study. The administration of a\r<br>             single injection for treatment or prophylaxis of a condition unrelated to the\r<br>             patient's MS or the patient's RNF therapy (e.g., influenza or pneumococcus\r<br>             vaccination) will be acceptable\r<br>\r<br>          -  Receive any MS therapy other than Rebif / RNF (e.g., other disease-modifying drug\r<br>             [DMD]s: immunomodulatory , immunosuppressive agents or combination therapy) within 12\r<br>             months prior to study enrolment or at any time during the study\r<br>\r<br>          -  Receive oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within\r<br>             30 days prior to SD1\r<br>\r<br>          -  Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 3 x\r<br>             upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2\r<br>             x ULN if associated with any elevation of ALT or alkaline phosphatase\r<br>\r<br>          -  Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5\r<br>             x lower limit of normal\r<br>\r<br>          -  Have moderate to severe renal impairment\r<br>\r<br>          -  History of any chronic pain syndrome\r<br>\r<br>          -  Any visual or physical impairment that precludes the subject self-injecting the\r<br>             treatment using the RebiSmartä\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis",
            "intervention": "Drug: Rebif® New Formulation (RNF) using RebiSmartTM;Drug: Rebif® New Formulation (RNF) using RebiSmartTM;Drug: Rebif® New Formulation (RNF) using RebiSmartTM;Drug: Rebif® New Formulation (RNF) using RebiSmartTM",
            "primary_outcome": "The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF).;The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF).",
            "secondary_outcome": "Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 4;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 8;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 12;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 4;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 8;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 12;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 4;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 8;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 12;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 4;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 8;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 12;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 4;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 8;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 12;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 4;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 8;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 12;The Incidence of Predefined Injection Site Reactions, MSTCQ Scores, Side Effects, McGill Pain Questionnaire, Visual Analog Scale, and Rating of Pain Regarding Injection Pain Following RNF Administration With RebiSmart at 12-week Treatment Period.",
            "secondary_id": "28733",
            "source_support": "Please refer to primary and secondary sponsors",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3629,
            "title": "The Effect of the Dose of PI-2301 on Safety, Tolerability, and Pharmacokinetics in Subjects with the Secondary Progressive Form of Multiple Sclerosis\nA double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) trial",
            "summary": null,
            "published_date": "2008-08-18T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.596379Z",
            "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007759-15",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "euctr": "EUCTR2007-007759-15-HU"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "2471913",
            "last_refreshed_on": "2012-03-19",
            "scientific_title": "The Effect of the Dose of PI-2301 on Safety, Tolerability, and Pharmacokinetics in Subjects with the Secondary Progressive Form of Multiple Sclerosis\nA double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) trial",
            "primary_sponsor": "PEPTIMMUNE Inc",
            "retrospective_flag": "Yes",
            "date_registration": null,
            "source_register": "EU Clinical Trials Register",
            "recruitment_status": "Not Recruiting",
            "other_records": "No",
            "inclusion_agemin": null,
            "inclusion_agemax": null,
            "inclusion_gender": "<br>Female: yes<br>Male: yes<br>",
            "date_enrollement": "2008-10-11",
            "target_size": "53",
            "study_type": "Interventional clinical trial of medicinal product",
            "study_design": "Controlled: yes\nRandomised: yes\nOpen: yes\nSingle blind: no\nDouble blind: yes\nParallel group: no\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no",
            "phase": null,
            "countries": "Hungary",
            "contact_firstname": null,
            "contact_lastname": null,
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": null,
            "inclusion_criteria": "Inclusion criteria: <br>1.  Male or female subjects between the ages of 18 and 60 (inclusive) who have signed an approved, informed consent document.<br>2.  Patients must have a current diagnosis of SP-MS with duration of diagnosis of at least 1 year and less than 10 years from the baseline examination.<br>3.  Female subjects must not be pregnant or lactating. If of childbearing potential, subjects must decide in conjunction with their physician on a double contraceptive method that they will use in order to avoid being pregnant since at least 14 days before their entry in the study as well as throughout the duration of the study.<br> 4.  If a female subject is unable to bear children, this must be documented on the Case Report Form (CRF; e.g., tubal ligation, hysterectomy, postmenopausal). Postmenopausal is defined as a minimum of 1 year since the last menstrual period.<br>5.  Subject must have evidence of MS obtained by MRI (T1 weighted imaging with gadolinium contrast) using a 1.5 Tesla magnet within 1 year of the baseline examination with =10 active gadolinium enhancing lesions).<br>6.  EDSS of = 3 and <7.<br>7.  Subjects must be willing and able to comply with the protocol requirements.<br>8.  With the exception of signs and symptoms that directly relate to their MS, subjects must be in good general health, without significant medical history, physical examination findings, or clinically-significant abnormal laboratory results.<br>9.     Subjects must have a negative alcohol breathalyzer test and a urine screen for drugs of abuse at the Screening Visit.<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br>",
            "exclusion_criteria": "Exclusion criteria: <br>1.  Currently or within the past 5 years, history of malignancy other than squamous or basal cell carcinoma of the skin.<br>2.  A current diagnosis or recent history within 2 years of alcoholism; drug abuse; or severe emotional, behavioral, or psychiatric problems that would hinder adequate compliance with study requirements.<br>3.  History of clinically significant gastrointestinal, renal, hepatic, endocrinic, oncologic, pulmonary or cardiovascular disease; or a history of tuberculosis, epilepsy, diabetes, psychosis, glaucoma; or any other condition, which in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.<br>4  Clinically significant abnormality on screening or baseline ECG (allowable abnormalities: occasional premature atrial beats, abnormal PR interval not associated w/ SVT or heart block, RBBB, resting ST =100 or SB = 50).<br>5.  A positive pregnancy test at the Screening Visit (serum test) or Day 1, prior to drug administration (urine test).<br>6.  MRI at Screening showing >10 CNS gadolinium-enhancing lesions on T1 scans consistent with Multiple Sclerosis, using a 1.5 Tesla magnet.<br>7.  Any relapse of multiple sclerosis within the prior 3 months.<br>8.  Immunosuppression due to acquired immunodeficiency syndrome (AIDS), or cancer chemotherapy within the 6 months prior to the Screening Visit, or other etiology of immunosuppression.<br>9.  History or evidence of hepatitis B or C.<br>10.  Participation in a previous investigational drug or device study within 30 days preceding the Screening Visit.<br>11.  History of any prior Copaxone®, Cellcept, Tysabri, or Campath use.<br>12.  History of total lymphoid irradiation.<br>13.  History within the prior 3 months prior to the Screening Visit of glucocorticoid therapy.<br>14.  History within the prior 6 months prior to the Screening Visit of any of the following:  azathioprine, cladribine, cyclophosphamide, cyclosporine, interferon beta-1a or interferon beta-1b, methotrexate, or mitoxantrone.<br><br>",
            "condition": "Patients with current diagnosis of SP-MS <br>MedDRA version: 9.1\nLevel: LLT\nClassification code 10063400\nTerm: Secondary progressive multiple sclerosis",
            "intervention": "<br>Product Name: PI-2301<br>Product Code: CO-14<br>Pharmaceutical Form: Solution for injection<br>CAS Number: 1026791-33-1<br>Current Sponsor code: PI-2301<br>Other descriptive name: CO-14<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 20-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Subcutaneous use<br><br>",
            "primary_outcome": "Main Objective: The primary objective of this study is to evaluate the safety and tolerability of 4 to 6 dose levels of PI 2301 in subjects with SP-MS when administered weekly for up to 12 weeks;Secondary Objective: The secondary objectives of this study are to evaluate the pharmacokinetics, effects on immunological/biological markers, magnetic resonance imaging (MRI), and the Expanded Disability Status Scale (EDSS) of 4 to 6 dose levels of PI-2301 in subjects with SP-MS when administered weekly for up to 12 weeks;Primary end point(s): Safety parameters : <br>Safety will be monitored with using physical examinations, vital signs, ECGs, laboratory testing, and AE/SAE assessments.  Particular attention will be focused on monitoring for anaphylaxis or hypersensitivity reactions, systemic inflammatory response syndrome (SIRS), and injection site reaction (ISR).  <br>",
            "secondary_outcome": null,
            "secondary_id": "CO-200-102",
            "source_support": null,
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        }
    ]
}