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=72",
    "previous": "http://api.gregory-ms.com/trials/?format=api&page=70",
    "results": [
        {
            "trial_id": 3618,
            "title": "A Long-Term Open Label Extension Study to assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus.",
            "summary": null,
            "published_date": "2008-03-10T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.360074Z",
            "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007663-25",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "euctr": "EUCTR2007-007663-25-GB"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "8616660",
            "last_refreshed_on": "2019-12-10",
            "scientific_title": "A Long-Term Open Label Extension Study to assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus.",
            "primary_sponsor": "Merz Pharmaceuticals GmbH",
            "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": "2008-11-17",
            "target_size": "48",
            "study_type": "Interventional clinical trial of medicinal product",
            "study_design": "<br>                Controlled: no<br>                Randomised: no<br>                Open: yes<br>                Single blind: no<br>                Double blind: no<br>                Parallel group: no<br>                Cross over: no<br>                Other: no<br>                If controlled, specify comparator, Other Medicinial Product: no<br>                Placebo: no<br>                Other: no<br>",
            "phase": "Human pharmacology (Phase I): no\n                Therapeutic exploratory (Phase II): yes\n                Therapeutic confirmatory - (Phase III): no\n                Therapeutic use (Phase IV): no",
            "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>                •\tMale or female patients between 18 and 81 years (inclusive) of age who have successfully completed both study periods in the previous double-blind protocol MRZ 92579 0707/1 and who have been deemed eligible (had a response to treatment) in the judgment of the Investigator;<br>                •\tPatient fulfilled, at entry into the double-blind study, the diagnostic criteria for congenital idiopathic nystagmus (CIN) or nystagmus secondary to multiple sclerosis (MS);<br>                •\tPatient has been properly informed of the nature and risks of the study and has given written informed consent prior to entering the study;<br>                •\t12 lead electrocardiogram (ECG) without clinically significant abnormalities at baseline;<br>                •\tAble and willing to comply with instructions during the outpatient periods;<br>                •\tFor females of childbearing potential (last menses less than one year prior to enrolment): negative pregnancy test at baseline (i.e. prior to entry in the double-blind treatment phase); not breast-feeding; either surgically sterile or agreement to use a medically accepted, highly effective contraception  during the entire duration of the study.<br>                Multiple sclerosis patients only:<br>                •\t‘multiple sclerosis’ patients must be neurologically stable with no evidence of acute relapse.<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) yes<br>                F.1.3.1 Number of subjects for this age range<br>",
            "exclusion_criteria": "Exclusion criteria: <br>                •\tOccurrence of any major treatment-emergent adverse event or condition during the previous protocol (MRZ 92579 0707/1) that, in the opinion of the Investigator, should exclude the patient from participating in the open label extension;<br>                •\tPatients with a clinically significant medical or surgical condition at baseline which might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic system or other conditions / abnormalities of sufficient severity that would preclude safe enrollment in the study or interfere with their participation in the study (e.g. psychiatric disorder);<br>                •\tPatients with arterial hypertension (systolic blood pressure greater than 180 mmHg or less than 90 mmHg), or hypotension (diastolic blood pressure greater than 105 mmHg or less than 50 mmHg) at baseline;<br>                •\tPatients with known hypersensitivity or intolerance to neramexane, amantadine, or memantine;<br>                •\tPatients with known or suspected alcoholism or drug abuse<br>                •\tPatients requiring concomitant treatment with any prohibited prescription or over-the-counter medication (Appendix 11.1);<br>                •\tRelevant non-compliance issue(s) in the previous protocol or a history of chronic non-compliance with drug regimens;<br>                •\tPatients who, in the judgment of the Investigator, might not be suitable for enrollment into the study.<br>                Multiple sclerosis patients only:<br><br>",
            "condition": "congenital idiopathic nystagmus and aquired nystagmus <br>\n                MedDRA version: 9.1\n                Level: LLT\n                Classification code 10029864\n                Term: Nystagmus\n             <br>\n                MedDRA version: 9.1\n                Level: LLT\n                Classification code 10029867\n                Term: Nystagmus congenital",
            "intervention": "<br>                Product Name: Neramexane mesylate MR film-coated tablet 25 mg<br>                Pharmaceutical Form: Modified-release tablet<br>                INN or Proposed INN: Neramexane Mesylate<br>                CAS Number: 457068-92-7<br>                Other descriptive name: 1-Amino-1,3,3,5,5-Pentamethylcyclohexane-Mesylate<br>                Concentration unit: mg milligram(s)<br>                Concentration type: equal<br>                Concentration number: 25-<br><br>",
            "primary_outcome": "Main Objective: The main purpose of the study is to evaluate the long-term safety and tolerability of daily doses of 25, 50, or 75 mg neramexane mesylate in the treatment of congenital idiopathic nystagmus or nystagmus secondary to multiple sclerosis. The study will also investigate the permanence of visual acuity improvement (long-term efficacy).;Secondary Objective: ;Primary end point(s): The primary objective of this open-label, extension study is to evaluate the long-term safety and tolerability of daily doses of 25, 50, or 75 mg neramexane mesylate in the treatment of CIN or nystagmus secondary to multiple sclerosis.  A further objective of the trial will be to investigate the permanence of visual acuity improvement.",
            "secondary_outcome": null,
            "secondary_id": "MRZ 92579-0738/1",
            "source_support": null,
            "ethics_review_status": "Approved",
            "ethics_review_approval_date": "1900-01-01",
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": "2010-10-06",
            "results_url_link": null
        },
        {
            "trial_id": 3617,
            "title": "Cognitive behavioural therapy software for the treatment of depression in people with multiple sclerosis",
            "summary": null,
            "published_date": "2008-06-10T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.340034Z",
            "link": "http://isrctn.com/ISRCTN81846800",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "isrctn": "ISRCTN81846800"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "9065142",
            "last_refreshed_on": "2020-04-06",
            "scientific_title": "Computerised cognitive behavioural therapy for treatment of depression in multiple sclerosis (MS) (CoSMoS): Clinical trial pilot study",
            "primary_sponsor": "University of Sheffield (UK)",
            "retrospective_flag": "No",
            "date_registration": null,
            "source_register": "ISRCTN",
            "recruitment_status": "Not Recruiting",
            "other_records": "No",
            "inclusion_agemin": null,
            "inclusion_agemax": null,
            "inclusion_gender": "Both",
            "date_enrollement": "2008-01-09",
            "target_size": "24",
            "study_type": "Interventional",
            "study_design": "Parallel group randomised pilot trial (Treatment)",
            "phase": "Not Specified",
            "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. Aged 18+, both males and females<br>                2. Diagnosis of MS confirmed by neurologist<br>                3. Beck Depression Inventory-II score of at least 14 on two consecutive occasions<br>                4. Not currently or within past three months receiving any treatment from a psychologist, psychotherapist or psychiatrist<br>                5. Willingness to be randomised to CCBT, at home or primary care facility or treatment as usual<br>",
            "exclusion_criteria": "Exclusion criteria: <br>                1. Unable to read or write English<br>                2. Beck Depression Inventory score of at least 29 on two consecutive occasions<br>                3. Active suicidal ideas<br>                4. Current or life-time diagnosis of any of the following:<br>                4.1. Psychosis<br>                4.2. Organic mental disorder<br>                4.3. Alcohol or drug dependency<br>                5. Kurtzke Expanded Disability Status Scale (EDSS) score of 8.5 or above<br>                6. Unable to use the CCBT package due to physical disability<br>                7. Unable to use the CCBT package due to cognitive symptoms (mini-mental state of 20 below or if, in the opinion of the study psychologist, the individual would be unlikely to benefit from CCBT)<br>",
            "condition": "Depression in people with multiple sclerosis (MS) <br>Mental and Behavioural Disorders <br>Depressive episodes in MS sufferers",
            "intervention": "<br>                Participants are randomly allocated to one of two groups.<br><br>                Intervention group: CBT software (Ultrasis - Beating the Blues®)<br>                Control group: Treatment as usual<br><br>                Ultrasis - Beating the Blues® is a computer-interactive programme for the treatment of anxiety and depression. It is based on cognitive behavioural therapy (CBT), which helps patients to identify and change unhelpful ways of thinking and to learn more effective ways of solving problems. The programme consists of two interwoven strands: the cognitive (or \"thinking\") strategies and the behavioural (or \"doing\") strategies. Patients are helped to understand the causes and symptoms of anxiety and depression and to work on their specific problems. The programme consists of a 15 minute \"Introduction to Therapy\" video plus eight computer-interactive sessions of approximately 50 minutes each in duration. Each session consists of a mix of cognitive and behavioural strategies, which are customised to the patient's individual problems. The eight computer sessions are designed to be taken weekly, or thereabouts, and each session builds on the previous one. Patients can repeat sessions if they wish. The computer keeps track of which session they have reached.<br><br>                Total duration of interventions: 8 weeks<br>                Total duration of follow-up: 3 months<br>",
            "primary_outcome": "Change in self-reported symptoms of depression: the difference between mean change scores of CCBT and standard care, as measured on the Beck Depression Inventory - Second Edition (BDI-II) 21-item self report instrument. Recorded at baseline, eight weeks or on completion of CCBT (whichever is later) and three months thereafter.",
            "secondary_outcome": "<br>                The following will be recorded at baseline, eight weeks or on completion of CCBT (whichever is later) and three months thereafter:<br>                1. Depression as measured on the Patient Health Questionnaire-9 item (PHQ-9)<br>                2. Anxiety measured on the Generalised Anxiety Disorder-7 item (GAD-7)<br>                3. Disease-specific quality of life, measured on the Multiple Sclerosis Impact Scale-29 item (MSIS-29)<br>                4. Generic health-related quality of life, measured on the 36-item Short Form health survey (SF-36)<br>",
            "secondary_id": "NCT00678496;112276",
            "source_support": "Multiple Sclerosis Society (UK) (ref: 845/06)",
            "ethics_review_status": null,
            "ethics_review_approval_date": "1900-01-01",
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": "Northern and Yorkshire NHS Research Ethics Committee, 05/09/2008, ref: 08/H0903/41",
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": "2010-01-31",
            "results_url_link": null
        },
        {
            "trial_id": 3616,
            "title": "A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a",
            "summary": null,
            "published_date": "2008-07-10T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.318127Z",
            "link": "http://clinicaltrials.gov/show/NCT00771043",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT00771043"
            },
            "categories": [
                {
                    "category_id": 7,
                    "category_description": "",
                    "category_name": "Natalizumab",
                    "category_slug": "natalizumab",
                    "category_terms": [
                        "natalizumab",
                        "tysabri"
                    ],
                    "article_count": 295
                }
            ],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "4648490",
            "last_refreshed_on": "2015-02-19",
            "scientific_title": "Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a",
            "primary_sponsor": "Biogen Idec",
            "retrospective_flag": "Yes",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "18 Years",
            "inclusion_agemax": "55 Years",
            "inclusion_gender": "Both",
            "date_enrollement": "2008-11-28",
            "target_size": "50",
            "study_type": "Interventional",
            "study_design": "Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",
            "phase": "Phase 4",
            "countries": "United States",
            "contact_firstname": null,
            "contact_lastname": null,
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": null,
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Diagnosis of RRMS.\r<br>\r<br>          -  Patients with unilateral AON consistent with Multiple Sclerosis (MS).\r<br>\r<br>          -  Treatment with intravenous methylprednisolone (IVMP) at 1gm daily for  three days\r<br>             after the onset of AON, without a taper, and completed within 14 days of the AON\r<br>             symptom onset.\r<br>\r<br>          -  Age 18-55 years.\r<br>\r<br>          -  Expanded Disability Status Scale (EDSS) 0 to 5.0.\r<br>\r<br>          -  Understand and sign informed consent.\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  History or presence of progressive multifocal leukoencephalopathy (PML).\r<br>\r<br>          -  Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Secondary Progressive\r<br>             Multiple Sclerosis (SPMS).\r<br>\r<br>          -  Immune-compromised in the judgment of the Investigator.\r<br>\r<br>          -  History of or presence of clinically significant medical illness or laboratory\r<br>             abnormality that, in the opinion of the investigator or Sponsor, would preclude\r<br>             participation in the study.\r<br>\r<br>          -  Concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, etc).\r<br>\r<br>          -  Previous history of severe disc edema, hemorrhage, or > 1 confirmed optic neuritis\r<br>             (ON) with the most recent ON symptom onset being less than 12 months ago.\r<br>\r<br>          -  Previous treatment with > 1 Disease Modifying Therapy (DMT).\r<br>\r<br>          -  Previous treatment with investigational products for MS, immunosuppressant or\r<br>             cytotoxic therapy.\r<br>\r<br>          -  Previous treatment with TYSABRI®\r<br>\r<br>          -  Women who are not postmenopausal, surgically sterile, or willing to practice\r<br>             contraception.\r<br>\r<br>          -  Women pregnant, breast feeding, or planning to become pregnant.\r<br>\r<br>          -  Involved with other study protocol simultaneously without prior approval.\r<br>\r<br>          -  Determined not suitable for study participation by Investigator and/or Sponsor.\r<br>",
            "exclusion_criteria": null,
            "condition": "Relapsing-Remitting Multiple Sclerosis",
            "intervention": "Drug: TYSABRI and AVONEX",
            "primary_outcome": "Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups.",
            "secondary_outcome": "Changes in average RNFL thickness of affected eyes (corrected by fellow eyes) across treatment groups.",
            "secondary_id": "US 010-07-NAT",
            "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": 3615,
            "title": "An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis TOWER",
            "summary": null,
            "published_date": "2008-10-10T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.298191Z",
            "link": "https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=111-08",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "per": "PER-111-08"
            },
            "categories": [
                {
                    "category_id": 14,
                    "category_description": "Aubagio is a medicine that contains the active substance teriflunomide. It is used to treat patients from the age of 10 years with multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves. \r\n\r\nAubagio is used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).",
                    "category_name": "Aubagio",
                    "category_slug": "aubagio",
                    "category_terms": [
                        "teriflunomide",
                        "aubagio"
                    ],
                    "article_count": 102
                }
            ],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "13333922",
            "last_refreshed_on": "2023-09-04",
            "scientific_title": "A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis",
            "primary_sponsor": "sanofi-aventis Recherche & Development,",
            "retrospective_flag": "Yes",
            "date_registration": null,
            "source_register": "REPEC",
            "recruitment_status": "Not Recruiting",
            "other_records": "No",
            "inclusion_agemin": "18",
            "inclusion_agemax": "55",
            "inclusion_gender": "--",
            "date_enrollement": "1900-01-01",
            "target_size": "16",
            "study_type": "Interventional",
            "study_design": "<br>\t\t\tPlacebo-controlled, parallel-group study (4 groups) multicenter, multinational, randomized;<br>\t\t\tdouble blind between the oral dose arms and open for the beta interferon arm (Rebif®), using a caliper arm, Rebif® (interferon beta 1a) and an evaluating doctor who is blinded to the entire treatment.<br>",
            "phase": "III",
            "countries": "China;Philippines;Thailand;Turkey;Germany;Austria;Belgium;Belarus;Slovakia;Spain;Estonia;France;Greece;Netherlands;Poland;United Kindgdom;Romania;Sweden;Ukraine;Australia;Czech Republic;South Africa;Canada;Chile;Mexico;United States",
            "contact_firstname": "Pablo",
            "contact_lastname": "Acevedo",
            "contact_address": "Av. Javier Prado Este N° 444 Int. 1501, Urb. Jardin",
            "contact_email": "[email protected]",
            "contact_tel": "988180698/ 4114710 anexo 4804",
            "contact_affiliation": "SANOFI AVENTIS DEL PERU S.A.",
            "inclusion_criteria": "Inclusion criteria: \r<br>\t\t\t• Patients with multiple sclerosis recurrence varieties that meet McDonald´s criteria for the diagnosis of MS at the time of the selection visit and EDSS 55.5 score at the selection visit\r<br>\t\t\t• At least one relapse in the 12 months preceding the random assignment or at least 2 relapses in the 24 months preceding the random assignment visit\r<br>\t\t\t• Provide signed informed consent in the form of informed consent\r<br>",
            "exclusion_criteria": "Exclusion criteria: \r<br>\t\t\t• <18 years of age or> 56 years of age\r<br>\t\t\t• Patients with significant bone marrow dysfunction or significant anemia, leukopenia or thrombocytopenia\r<br>\t\t\t• Persistent, significant or severe infection\r<br>\t\t\t• Impaired hepatic function or persistent elevations (confirmed by a second test) of serum glutamic pyruvic transaminase (SGPT / ALT), serum glutamicoxalastic transaminase (SGOT / AST) or direct bilirubin greater than 1.5-times the upper limit of normal\r<br>\t\t\t• Known history of hepatitis\r<br>\t\t\t• Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 2 weeks prior to randomization\r<br>\t\t\t• Patients positive for human immunodeficiency virus (HIV)\r<br>\t\t\t• Prior or concomitant use of cladribine, mitoxantrone or other immunosuppressive agents, such as azathioprine, cyclofosfamide, cyclosporin, methotrexate or mycophenolate\r<br>\t\t\t• Concomitant or prior use of natalizumab (Tysabri®)\r<br>\t\t\t• Breastfeeding or pregnant women\r<br>",
            "condition": "-G35  Multiple sclerosis\r\n\t\t <br>Multiple sclerosis;G35 ;Multiple sclerosis",
            "intervention": "<br>\t\t\tGroup name:Group 1 Type of group;1 N° of participants:430 Intervention(s) description:Teriflunomide 7 mg once daily during 48 weeks<br>\t\t\tGroup name:Group 3 Type of group;2 N° of participants:430 Intervention(s) description:Placebo (for teriflunomide) once daily for 48 weeks<br>",
            "primary_outcome": "<br>Outcome name:ARR is obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations.<br>Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores.<br>To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and baseline EDSS stratum as covariates).<br><br><br>Measure:Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate<br>Timepoints:Core treatment period between 48 - 152 weeks depending on time of enrollment<br>",
            "secondary_outcome": "<br>\t\t\tOutcome name:FIS is a participants-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in 3 areas; physical, cognitive, and social.\r<br>\t\t\tFIS total score ranges from 0 (no problem) to 160 (extreme problem).\r<br>\t\t\tBaseline adjusted least-squares means at week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model.\r<br>\t\t\tMeasure:Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score\r<br>\t\t\tTimepoints:Baseline (before randomization), Week 12, Week 24 and Week 48\r<br>\t\t;\r<br>\t\t\tOutcome name:Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for FIS total score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors).\r<br>\r<br>\t\t\tMeasure:Core Treatment Period: Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score\r<br>\t\t\tTimepoints:Baseline (before randomization) and up to Week 152\r<br>\t\t;\r<br>\t\t\tOutcome name:SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument. It is constructed such that the 36 questions represent 8 of the most important health concepts: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.\r<br>\r<br>\r<br>\t\t\tMeasure:Core Treatment Period: Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores\r<br>\t\t\tTimepoints:Baseline (before randomization), Week 12, Week 24 and Week 48\r<br>\t\t;\r<br>\t\t\tOutcome name:Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for each summary score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors).\r<br>\r<br>\t\t\tMeasure:Core Treatment Period: Change From Baseline to Last Visit in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores\r<br>\t\t\tTimepoints:Baseline (before randomization) and up to Week 152\r<br>\t\t;\r<br>\t\t\tOutcome name:Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.\r<br>\r<br>\t\t\tMeasure:Core Treatment Period: Overview of Adverse Events\r<br>\t\t\tTimepoints:From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first\r<br>\t\t;\r<br>\t\t\tOutcome name:AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.\r<br>\r<br>\t\t\tMeasure:Extension Treatment Period: Overview of Treatment Emergent Adverse Events (TEAE)\r<br>\t\t\tTimepoints:From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period\r<br>\t\t;\r<br>\t\t\tOutcome name:EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation.\r<br>\t\t\tEDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS).\r<br>\t\t\tBaseline adjusted least-squares means at Week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on EDSS score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model.\r<br>\r<br>\r<br>\t\t\tMeasure:Core Treatment Period: Change From Baseline to Week 48 in EDSS Total Score\r<br>\t\t\tTimepoints:Baseline (before randomization), Week 12, Week 24, Week 36 and Week 48\r<br>\t\t;\r<br>\t\t\tOutcome name:Probability of disability progression at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first 12-week sustained disability progression [i.e. increase from baseline of at least 1 point in EDSS score (at least 0.5 point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks].\r<br>\t\t\tParticipants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.\r<br>\t\t\tKaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time &#8804;t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t.\r<br>\t\t\tMeasure:Core Treatment Period: Time to Disability Progression\r<br>\t\t\tTimepoints:Core treatment period between 48 - 152 weeks depending on time of enrollment\r<br>\t\t;\r<br>\t\t\tOutcome name:Probability of no relapse at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to relapse defined as the time from randomization to first EDSS confirmed relapse.\r<br>\t\t\tParticipants free of confirmed relapse (no EDSS confirmed relapse observed on treatment) were censored at the date of the last study drug intake.\r<br>\t\t\tMeasure:Core Treatment Period: Time Without Relapse\r<br>\t\t\tTimepoints:Core treatment period between 48 - 152 weeks depending on time of enrollment\r<br>",
            "secondary_id": "NCT00751881;EUCTR2007-004452-36-ES",
            "source_support": null,
            "ethics_review_status": "Approved",
            "ethics_review_approval_date": "2008-05-29",
            "ethics_review_contact_name": "[email protected]",
            "ethics_review_contact_address": "Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma",
            "ethics_review_contact_phone": "616-5500 Anx. 246",
            "ethics_review_contact_email": "[email protected]",
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3614,
            "title": "Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple Sclerosis",
            "summary": null,
            "published_date": "2008-10-13T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.278753Z",
            "link": "http://clinicaltrials.gov/show/NCT00772525",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT00772525"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "4648603",
            "last_refreshed_on": "2015-02-19",
            "scientific_title": "A Double-blind, Placebo-controlled, Randomized Crossover, Activity Study of Single Oral Doses of 50 mg and 400 mg Nerispirdine on Visual Function in Patients With Multiple Sclerosis",
            "primary_sponsor": "Sanofi",
            "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": "2008-09-28",
            "target_size": "31",
            "study_type": "Interventional",
            "study_design": "Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment",
            "phase": "Phase 2",
            "countries": "United States",
            "contact_firstname": "",
            "contact_lastname": "Robert SERGOTT, MD",
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": "Wills Eye Institute, Thomas Jefferson University, Philadelphia Pennsylvania, USA",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Clinically definite MS (McDonald criteria), which includes patients with\r<br>             remitting-relapsing, secondary progressive, progressive-relapsing, or primary\r<br>             progressive MS who have had a past history of Optic Neuritis.\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Multiple sclerosis exacerbation within 60 days of the Screening Visit and the relapse\r<br>             involved the visual fields or visual acuity\r<br>\r<br>          -  No eye with appropriate degree of lesions for this study as defined by criteria based\r<br>             on degree of visual acuity deficit, refractive error, VEP P100 latency and average\r<br>             retinal nerve fiber layer thickness of as measured by Optical Coherence Tomography\r<br>             (OCT)\r<br>\r<br>          -  Any MS-unrelated prior ophthalmological impairment (eg, compressive, ischemic, toxic,\r<br>             or nutritional optic neuropathies, Leber's hereditary optic atrophy)\r<br>\r<br>          -  Previously exposed to 3,4-diaminopyridine or 4-aminopyridine\r<br>\r<br>        The above information is not intended to contain all considerations relevant to a\r<br>        patient's potential participation in a clinical trial.\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis;Optic Nerve;Neuritis",
            "intervention": "Drug: Nerispirdine (HP184);Drug: Placebo",
            "primary_outcome": "Visual Evoked Potential (P100) latency",
            "secondary_outcome": "Pelli-Robson Contrast Sensitivity Score;Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score;Visual Evoked Potential (VEP) amplitude",
            "secondary_id": "ACT10573",
            "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": 3613,
            "title": "Group exercise therapy for mobility and balance in people with multiple sclerosis",
            "summary": null,
            "published_date": "2008-10-17T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.246433Z",
            "link": "http://isrctn.com/ISRCTN78227711",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "isrctn": "ISRCTN78227711"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "4529046",
            "last_refreshed_on": "2015-01-13",
            "scientific_title": "Group exercise therapy for mobility and balance in people with multiple sclerosis: a randomised controlled trial",
            "primary_sponsor": "University of Ulster (UK)",
            "retrospective_flag": "No",
            "date_registration": null,
            "source_register": "ISRCTN",
            "recruitment_status": "Not Recruiting",
            "other_records": "No",
            "inclusion_agemin": null,
            "inclusion_agemax": null,
            "inclusion_gender": "Both",
            "date_enrollement": "2008-01-03",
            "target_size": "160",
            "study_type": "Interventional",
            "study_design": "Single-blind, randomised, single-centre trial (Treatment)",
            "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: 1. Confirmed diagnosis of MS<br>2. Male or female, over 18 years of age<br>3. In a stable phase of their MS<br>4. Cognitively they must have a Score of 6 or more in the 10-point mini mental score (Hodkinson, 1972)<br>5. A minimum score of 14 on the Rivermead Mobility Index",
            "exclusion_criteria": "Exclusion criteria: 1. The Expanded Disability Status Scale (EDSS) >7.00<br>2. Serious other medical or surgical condition",
            "condition": "Multiple sclerosis with balance and mobility problems <br>Nervous System Diseases <br>Multiple sclerosis",
            "intervention": "The exercise group will attend an exercise class twice per week for 6 weeks. The exercises will consist of 8 different stations and will be staged according to ability. Each class will last approximately 90 minutes with 10 minutes warm up, 3 minutes per exercise, 3 minutes rest in between and a cool down period/discussion time at the end. <br><br>There is no intervention for the control group. At the end of the study period they will be offered 1-2 workshops (as necessary) at the end of the trial to teach them the exercises that were offered to the experimental group.",
            "primary_outcome": "Rivermead Mobility Index, assessed at baseline, immediately after the 6 weeks of intervention, and 3 and 6 months following discharge from the intervention. Analysis will be conducted on an intention to treat basis.",
            "secondary_outcome": "The following will be assessed at baseline, immediately after the 6 weeks of intervention, and 3 and 6 months following discharge from the intervention: <br>1. Berg Balance Scale <br>2. The Multiple Sclerosis Impact Scale (MSIS-29) <br>3. Multiple Sclerosis Walking Scale-12 <br>4. Barthel Index <br>5. MS Self-efficacy Scale <br><br>Analysis will be conducted on an intention to treat basis.",
            "secondary_id": "N/A",
            "source_support": "The Research and Development Office, Northern Ireland Health and Social Services Central Services Agency (United Kingdom) (grant ref: RRG 8.5-RRG/3277/05)",
            "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": 3612,
            "title": "AIMSPRO® and the bladder in multiple sclerosis (MS)",
            "summary": null,
            "published_date": "2008-10-24T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.218112Z",
            "link": "http://isrctn.com/ISRCTN17551402",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "isrctn": "ISRCTN17551402"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "8284174",
            "last_refreshed_on": "2019-08-26",
            "scientific_title": "A randomised, double-blind, placebo-controlled study of AIMSPRO® in secondary progressive multiple sclerosis (MS)",
            "primary_sponsor": "Daval International Ltd (UK)",
            "retrospective_flag": "Yes",
            "date_registration": null,
            "source_register": "ISRCTN",
            "recruitment_status": "Not Recruiting",
            "other_records": "No",
            "inclusion_agemin": null,
            "inclusion_agemax": null,
            "inclusion_gender": "Both",
            "date_enrollement": "2008-01-11",
            "target_size": "20",
            "study_type": "Interventional",
            "study_design": "Treatment, parallel-assignment, double-blind (subject, caregiver, investigator, outcomes assessor), randomised, crossover, placebo-controlled, safety/efficacy trial (Treatment)",
            "phase": "Not Applicable",
            "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. Male and female patients aged 18 years or older<br>                2. Men and women of childbearing potential must use adequate birth control measures for the duration of the study and should continue such precautions for 6 months after receiving the last injection of AIMSPRO®<br>                3. Clinically definite secondary progressive multiple sclerosis<br>                4. Ambulant, walking aids allowed<br>                5. No more than one relapse within the last 12 months and no relapse within the last 6 months<br>                6. Urinary frequency of 8 times per 24 hours<br>                7. Urinary urgency with or without urge incontinence<br>                8. Magnetic resonance imaging (MRI) brain or spinal cord abnormalities consistent with the diagnosis of MS<br>                9. Haemoglobin >9.5 g/dL<br>                10. White blood cells (WBC) >3.5 x 10^9/L<br>                11. Neutrophils >1.5 x 10^9/L<br>                12. Platelets >100 x 10^9/L<br>                13. Baseline AST, alkaline phosphatase, thyroid function, serum electrophoresis levels must be within their normal ranges<br>                14. Able to adhere to the study visit schedule and other protocol requirements<br>                15. Capable of giving written informed consent. Consent must be obtained prior to any screening procedures.<br>",
            "exclusion_criteria": "Exclusion criteria: <br>                1. Acute symptomatic urinary infection<br>                2. Taking DDAVP® for control of nocturia<br>                3. Taking antimuscarinic agents for the control of overactive bladder symptoms<br>                4. Full-time wheelchair user<br>                5. History of immunosuppressant drug therapy of any kind in the last 3 months<br>                6. Relapse within the last 6 months<br>                7. No clear progression of disability in the last 12 months<br>                8. Co-existent medical condition precluding participation, including any history of severe allergic reaction<br>                9. Pregnant or lactating women and women who are planning pregnancy within 12 months of screening (i.e., approximately 6 months following last injection)<br>                10. Receipt of any investigational drug within 30 days prior to screening or within 5 half-lives of the investigational agent, whichever is longer<br>                11. Treatment with any therapeutic agent targeted at reducing tumour necrosis factor (TNF) (e.g., infliximab, pentoxifylline, thalidomide, etanercept, etc) within 3 months of screening<br>                12. Previous administration of AIMSPRO®<br>                13. Ongoing corticosteroid therapy or any corticosteroids within the previous 3 months<br>                14. Known allergy to animal proteins<br>                15. Known history of tuberculosis<br>                16. Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months. Less serious infections such as acute upper respiratory tract infection or simple urinary tract infection should be followed to their conclusion or treated, as appropriate, prior to inclusion<br>                17. Opportunistic infections, including but not limited to evidence of active cytomegalovirus, active Pneumocystis carinii, Aspergillosis, histoplasmosis or atypical mycobacterium infection, etc, within the previous 6 months<br>                18. Established malignant disease or renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, or cardiac disease<br>                19. A significant other neurological disorder<br>                20. Presence of a transplanted organ, with the exception of a corneal transplant >3 months prior to screening<br>                21. History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly<br>                22. Known recent clinically significant substance abuse (drug or alcohol)<br>                23. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period<br>                24. Investigational drugs or drugs targeted at reducing TNF - these are not allowed during participation in the study<br>                25. Patients will not be permitted to receive immunosuppressive treatment during this study. The exception will be where a patient's treating neurologist determines that a course of steroid therapy, oral or intravenous, is required in view of a sufficiently disabling relapse of MS<br>                26. Immunosuppressive therapy within the month prior to entry into the study<br>                27. Taking the licensed anticonvulsant medication lamotrigine or the anti-arrhythmic drug flecainide, both of which are potent sodium chan",
            "condition": "Bladder dysfunction in patients with secondary progressive multiple sclerosis <br>Nervous System Diseases <br>Multiple sclerosis",
            "intervention": "<br>                AIMSPRO® (manufactured by Sypharma Pty Ltd, Australia) vs placebo (cross-over trial).<br><br>                1.0 ml twice weekly of AIMSPRO®/placebo for 4 weeks, injected subcutaneously, followed by a 6-week washout period and then the crossover medication for a further 4-week period.<br>",
            "primary_outcome": "To determine whether the regular administration of AIMSPRO® improves bladder dysfunction, manifest as an increase in average voided volume",
            "secondary_outcome": "<br>                1. To determine whether the regular administration of AIMSPRO® improves other manifestations of bladder dysfunction including frequency, urgency and incontinence episodes<br>                2. To determine whether regular administration of AIMSPRO® improves general disability<br>                3. To verify findings from a peer-reviewed uncontrolled observational study related to possible changes in colour vision in MS patients taking AIMSPRO®<br>",
            "secondary_id": "NCT01228396;DIMS04",
            "source_support": "Daval International Ltd (UK)",
            "ethics_review_status": null,
            "ethics_review_approval_date": "1990-01-01",
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": "National Research Ethics Committee, National Hospital for Neurology and Neurosurgery, University College London Hospitals Foundation NHS Trust",
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": "2012-01-03",
            "results_url_link": null
        },
        {
            "trial_id": 3611,
            "title": "Mesenchymal Stem Cells for the Treatment of MS",
            "summary": null,
            "published_date": "2008-10-28T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.172748Z",
            "link": "https://clinicaltrials.gov/show/NCT00781872",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT00781872"
            },
            "categories": [
                {
                    "category_id": 12,
                    "category_description": "Autologous Hematopoietic Stem Cell Transplantation (aHSCT) and other stem cell therapies",
                    "category_name": "Stem Cells",
                    "category_slug": "stem-cells",
                    "category_terms": [
                        "stem cells",
                        "Autologous hematopoietic stem cell",
                        "ahsct"
                    ],
                    "article_count": 221
                }
            ],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "10810626",
            "last_refreshed_on": "2021-04-12",
            "scientific_title": "Explorative Trial to Investigate the Safety and Clinical Effects of Autologous Mesenchymal Bone Marrow Stem Cells (MSC) Following Their Intrathecal and Intravenous Administration in Severe Cases of Multiple Sclerosis (MS)",
            "primary_sponsor": "Hadassah Medical Organization",
            "retrospective_flag": "No",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "35 Years",
            "inclusion_agemax": "65 Years",
            "inclusion_gender": "All",
            "date_enrollement": "2006-10-28",
            "target_size": "24",
            "study_type": "Interventional",
            "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).",
            "phase": "Phase 1/Phase 2",
            "countries": null,
            "contact_firstname": "",
            "contact_lastname": "Dimitrios Karussis, Prof.",
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": "Hadassah Medical Organization",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          1. Consenting patients fulfilling the Poser's clinical criteria for definite MS\r<br>\r<br>          2. Age: 35-65, males and females\r<br>\r<br>          3. Duration of disease: >5 years\r<br>\r<br>          4. Failure to the currently available -registered- for MS immunomodulatory treatments (ie\r<br>             interferons, Copaxone, immunosuppression): the lack of response to (at least two) of\r<br>             these treatments will be determined/defined by either an increase (deterioration) of\r<br>             at least one degree in the EDSS score during the last year or the appearance of at\r<br>             least two major relapses of MS during the same period of time (under treatment).\r<br>\r<br>        Exclusion criteria\r<br>\r<br>          1. Patients who were treated with cytotoxic medications (cyclophosphamide, Mitoxanthrobne\r<br>             etc) during the last 3 months prior to the inclusion\r<br>\r<br>          2. Patients suffering from significant cardiac, renal or hepatic failure or any other\r<br>             disease that may risk the patient or interfere with the ability to interpret the\r<br>             results\r<br>\r<br>          3. Patients with active infections\r<br>\r<br>          4. Patients with severe cognitive decline or inability to understand and sign the\r<br>             informed consent\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis",
            "intervention": "Biological: Injection of autologous bone marrow derived mesenchymal stem cells",
            "primary_outcome": "Safety of one or multiple intrathecaland intravenous injections of autologous MSC in Multiple sclerosis",
            "secondary_outcome": "Clinical effects in terms of changes in the expended disability status scale (EDSS) at 3-6 month intervals;Immunological effects of treatment with MSC in MS",
            "secondary_id": "MS22MSC-HMO-CTIL",
            "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": 3610,
            "title": "Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients",
            "summary": null,
            "published_date": "2008-10-29T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.152915Z",
            "link": "https://clinicaltrials.gov/show/NCT00784836",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT00784836"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "6491965",
            "last_refreshed_on": "2017-10-19",
            "scientific_title": "A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis",
            "primary_sponsor": "Biogen",
            "retrospective_flag": "No",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "18 Years",
            "inclusion_agemax": "60 Years",
            "inclusion_gender": "All",
            "date_enrollement": "2008-10-28",
            "target_size": "3",
            "study_type": "Interventional",
            "study_design": null,
            "phase": "Phase 3",
            "countries": "United States;United States;United States;United States",
            "contact_firstname": "; ; ;",
            "contact_lastname": "Medical Director;Medical Director;Medical Director;Medical Director",
            "contact_address": null,
            "contact_email": ";;;",
            "contact_tel": ";;;",
            "contact_affiliation": "Biogen;Biogen;Biogen;Biogen",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Ability to understand the purpose and risks of the study and provide signed and dated\r<br>             informed consent and authorization to use protected health information (PHI) in\r<br>             accordance with national and local subject privacy regulations.\r<br>\r<br>          -  Male or female aged 18- to 60-years-old, inclusive, at the time of informed consent.\r<br>\r<br>          -  Must have a diagnosis of relapsing MS.\r<br>\r<br>          -  Must have a screening Expanded Disability Status Scale (EDSS) score between 0 and 6.0,\r<br>             inclusive.\r<br>\r<br>          -  All male subjects and female participants of child-bearing potential must practice\r<br>             effective contraception during the study and be willing and able to continue\r<br>             contraception for 30 days after their last study dose of Avonex.\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  History of severe allergic or anaphylactic reactions.\r<br>\r<br>          -  Diagnosed with Primary progressive, secondary progressive, or progressive relapsing\r<br>             MS.\r<br>\r<br>          -  Known allergy to any component of the Avonex formulation.\r<br>\r<br>          -  History of any clinically significant (as determined by the investigator) cardiac,\r<br>             endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,\r<br>             neurologic, dermatologic, psychiatric renal, or other major disease.\r<br>\r<br>          -  Subjects with history of malignant disease, including solid tumors and hematologic\r<br>             malignancies.\r<br>\r<br>          -  History of seizure disorder or unexplained blackouts OR history of a seizure within 3\r<br>             months prior to Day 1.\r<br>\r<br>          -  History of suicidal ideation within 3 months prior to Day 1 or an episode of severe\r<br>             depression within 3 months prior to Day 1. Severe depression is defined as any episode\r<br>             of depression that requires hospitalization, or the initiation of antidepressant\r<br>             therapy, or an increase in the dose of an existing regimen of antidepressant therapy.\r<br>\r<br>          -  Clinically significant abnormal electrocardiogram (ECG) values as determined by the\r<br>             investigator.\r<br>\r<br>          -  Known history of, or a positive test result for, human immunodeficiency virus (HIV).\r<br>\r<br>          -  Known history of, or a positive test result for hepatitis C virus.\r<br>\r<br>          -  Abnormal screening blood tests exceeding any of the limits defined below:\r<br>\r<br>               1. Alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) greater\r<br>                  than 2 times the upper limit of normal or aspartate transaminase/serum glutamic\r<br>                  oxaloacetic transaminase or bilirubin.\r<br>\r<br>               2. Total white blood cell count (WBC) <3700 cells/mm\r<br>\r<br>               3. Platelet count <150,000 cells/mm\r<br>\r<br>               4. Hemoglobin <10 g/dL in female subjects; <11 g/dL in male subjects\r<br>\r<br>               5. Serum creatinine >upper limit of normal (ULN)\r<br>\r<br>               6. Prothrombin time (PT) or activated partial thromboplastin time (aPTT) > 1.2*ULN\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Ability to understand the purpose and risks of the study and provide signed and dated\r<br>             informed consent and authorization to use protected health information (PHI) in\r<br>             accordance with national and local subject privacy regulations.\r<br>\r<br>          -  Male or female aged 18- to 60-years-old, inclusive, at the time of informed consent.\r<br>\r<br>          -  Must have a diagnosis of relapsing MS.\r<br>\r<br>          -  Must have a screening Expanded Disability Status Scale (EDSS) score between 0 and 6.0,\r<br>             inclusive.\r<br>\r<br>          -  All male subjects and female participants of child-bearing potential must practice\r<br>             effective contraception during the study and be willing and able to continue\r<br>             contraception for 30 days after their last study dose of Avonex.\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  History of severe allergic or anaphylactic reactions.\r<br>\r<br>          -  Diagnosed with Primary progressive, secondary progressive, or progressive relapsing\r<br>             MS.\r<br>\r<br>          -  Known allergy to any component of the Avonex formulation.\r<br>\r<br>          -  History of any clinically significant (as determined by the investigator) cardiac,\r<br>             endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,\r<br>             neurologic, dermatologic, psychiatric renal, or other major disease.\r<br>\r<br>          -  Subjects with history of malignant disease, including solid tumors and hematologic\r<br>             malignancies.\r<br>\r<br>          -  History of seizure disorder or unexplained blackouts OR history of a seizure within 3\r<br>             months prior to Day 1.\r<br>\r<br>          -  History of suicidal ideation within 3 months prior to Day 1 or an episode of severe\r<br>             depression within 3 months prior to Day 1. Severe depression is defined as any episode\r<br>             of depression that requires hospitalization, or the initiation of antidepressant\r<br>             therapy, or an increase in the dose of an existing regimen of antidepressant therapy.\r<br>\r<br>          -  Clinically significant abnormal electrocardiogram (ECG) values as determined by the\r<br>             investigator.\r<br>\r<br>          -  Known history of, or a positive test result for, human immunodeficiency virus (HIV).\r<br>\r<br>          -  Known history of, or a positive test result for hepatitis C virus.\r<br>\r<br>          -  Abnormal screening blood tests exceeding any of the limits defined below:\r<br>\r<br>               1. Alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) greater\r<br>                  than 2 times the upper limit of normal or aspartate transaminase/serum glutamic\r<br>                  oxaloacetic transaminase or bilirubin.\r<br>\r<br>               2. Total white blood cell count (WBC) <3700 cells/mm\r<br>\r<br>               3. Platelet count <150,000 cells/mm\r<br>\r<br>               4. Hemoglobin <10 g/dL in female subjects; <11 g/dL in male subjects\r<br>\r<br>               5. Serum creatinine >upper limit of normal (ULN)\r<br>\r<br>               6. Prothrombin time (PT) or activated partial thromboplastin time (aPTT) > 1.2*ULN\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Ability to understand the purpose and risks of the study and provide signed and dated\r<br>             informed consent and authorization to use protected health information (PHI) in\r<br>             accordance with national and local subject privacy regulations.\r<br>\r<br>          -  Male or female aged 18- to 60-years-old, inclusive, at the time of informed consent.\r<br>\r<br>          -  Must have a diagnosis of relapsing MS.\r<br>\r<br>          -  Must have a screening Expanded Disability Status Scale (EDSS) score between 0 and 6.0,\r<br>             inclusive.\r<br>\r<br>          -  All male subjects and female participants of child-bearing potential must practice\r<br>             effective contraception during the study and be willing and able to continue\r<br>             contraception for 30 days after their last study dose of Avonex.\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  History of severe allergic or anaphylactic reactions.\r<br>\r<br>          -  Diagnosed with Primary progressive, secondary progressive, or progressive relapsing\r<br>             MS.\r<br>\r<br>          -  Known allergy to any component of the Avonex formulation.\r<br>\r<br>          -  History of any clinically significant (as determined by the investigator) cardiac,\r<br>             endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,\r<br>             neurologic, dermatologic, psychiatric renal, or other major disease.\r<br>\r<br>          -  Subjects with history of malignant disease, including solid tumors and hematologic\r<br>             malignancies.\r<br>\r<br>          -  History of seizure disorder or unexplained blackouts OR history of a seizure within 3\r<br>             months prior to Day 1.\r<br>\r<br>          -  History of suicidal ideation within 3 months prior to Day 1 or an episode of severe\r<br>             depression within 3 months prior to Day 1. Severe depression is defined as any episode\r<br>             of depression that requires hospitalization, or the initiation of antidepressant\r<br>             therapy, or an increase in the dose of an existing regimen of antidepressant therapy.\r<br>\r<br>          -  Clinically significant abnormal electrocardiogram (ECG) values as determined by the\r<br>             investigator.\r<br>\r<br>          -  Known history of, or a positive test result for, human immunodeficiency virus (HIV).\r<br>\r<br>          -  Known history of, or a positive test result for hepatitis C virus.\r<br>\r<br>          -  Abnormal screening blood tests exceeding any of the limits defined below:\r<br>\r<br>               1. Alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) greater\r<br>                  than 2 times the upper limit of normal or aspartate transaminase/serum glutamic\r<br>                  oxaloacetic transaminase or bilirubin.\r<br>\r<br>               2. Total white blood cell count (WBC) <3700 cells/mm\r<br>\r<br>               3. Platelet count <150,000 cells/mm\r<br>\r<br>               4. Hemoglobin <10 g/dL in female subjects; <11 g/dL in male subjects\r<br>\r<br>               5. Serum creatinine >upper limit of normal (ULN)\r<br>\r<br>               6. Prothrombin time (PT) or activated partial thromboplastin time (aPTT) > 1.2*ULN\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Ability to understand the purpose and risks of the study and provide signed and dated\r<br>             informed consent and authorization to use protected health information (PHI) in\r<br>             accordance with national and local subject privacy regulations.\r<br>\r<br>          -  Male or female aged 18- to 60-years-old, inclusive, at the time of informed consent.\r<br>\r<br>          -  Must have a diagnosis of relapsing MS.\r<br>\r<br>          -  Must have a screening Expanded Disability Status Scale (EDSS) score between 0 and 6.0,\r<br>             inclusive.\r<br>\r<br>          -  All male subjects and female participants of child-bearing potential must practice\r<br>             effective contraception during the study and be willing and able to continue\r<br>             contraception for 30 days after their last study dose of Avonex.\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  History of severe allergic or anaphylactic reactions.\r<br>\r<br>          -  Diagnosed with Primary progressive, secondary progressive, or progressive relapsing\r<br>             MS.\r<br>\r<br>          -  Known allergy to any component of the Avonex formulation.\r<br>\r<br>          -  History of any clinically significant (as determined by the investigator) cardiac,\r<br>             endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,\r<br>             neurologic, dermatologic, psychiatric renal, or other major disease.\r<br>\r<br>          -  Subjects with history of malignant disease, including solid tumors and hematologic\r<br>             malignancies.\r<br>\r<br>          -  History of seizure disorder or unexplained blackouts OR history of a seizure within 3\r<br>             months prior to Day 1.\r<br>\r<br>          -  History of suicidal ideation within 3 months prior to Day 1 or an episode of severe\r<br>             depression within 3 months prior to Day 1. Severe depression is defined as any episode\r<br>             of depression that requires hospitalization, or the initiation of antidepressant\r<br>             therapy, or an increase in the dose of an existing regimen of antidepressant therapy.\r<br>\r<br>          -  Clinically significant abnormal electrocardiogram (ECG) values as determined by the\r<br>             investigator.\r<br>\r<br>          -  Known history of, or a positive test result for, human immunodeficiency virus (HIV).\r<br>\r<br>          -  Known history of, or a positive test result for hepatitis C virus.\r<br>\r<br>          -  Abnormal screening blood tests exceeding any of the limits defined below:\r<br>\r<br>               1. Alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) greater\r<br>                  than 2 times the upper limit of normal or aspartate transaminase/serum glutamic\r<br>                  oxaloacetic transaminase or bilirubin.\r<br>\r<br>               2. Total white blood cell count (WBC) <3700 cells/mm\r<br>\r<br>               3. Platelet count <150,000 cells/mm\r<br>\r<br>               4. Hemoglobin <10 g/dL in female subjects; <11 g/dL in male subjects\r<br>\r<br>               5. Serum creatinine >upper limit of normal (ULN)\r<br>\r<br>               6. Prothrombin time (PT) or activated partial thromboplastin time (aPTT) > 1.2*ULN\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis",
            "intervention": "Drug: BG9418 (interferon beta 1-a);Drug: BG9418 (interferon beta 1-a);Drug: BG9418 (interferon beta 1-a);Drug: BG9418 (interferon beta 1-a)",
            "primary_outcome": "Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta);Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)",
            "secondary_outcome": "Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)",
            "secondary_id": "108MS303",
            "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": 3609,
            "title": "Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis",
            "summary": null,
            "published_date": "2008-04-11T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:21.117996Z",
            "link": "http://clinicaltrials.gov/show/NCT00785473",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT00785473"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "4649587",
            "last_refreshed_on": "2015-02-19",
            "scientific_title": "Can Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre Study",
            "primary_sponsor": "University Hospital of North Norway",
            "retrospective_flag": "No",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "18 Years",
            "inclusion_agemax": "50 Years",
            "inclusion_gender": "Both",
            "date_enrollement": "2008-01-28",
            "target_size": "80",
            "study_type": "Interventional",
            "study_design": "Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention",
            "phase": "Phase 4",
            "countries": "Norway",
            "contact_firstname": "",
            "contact_lastname": "Margitta T Kampman, MD, PhD",
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": "University Hospital of North Norway",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Age 18 to 50 years\r<br>\r<br>          -  EDSS < 4.0 (able to walk without rest some 500 m)\r<br>\r<br>          -  Women have to be premenopausal\r<br>\r<br>          -  MS according to the McDonald criteria; prepared and considered able to follow the\r<br>             protocol; using appropriate contraceptive methods (women of childbearing potential)\r<br>\r<br>          -  Having given written informed consent.\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Pregnancy or unwillingness to use contraception; alcohol or drug abuse\r<br>\r<br>          -  Use of glucocorticoid treatment other than intravenous methylprednisolone for\r<br>             treatment of relapses\r<br>\r<br>          -  Known allergy to cholecalciferol or arachis oil (peanuts)\r<br>\r<br>          -  Therapy with digitalis, calcitonin, active vitamin D3 analogues, fluoride, or\r<br>             bisphosphonates during the previous 12 months\r<br>\r<br>          -  Any condition predisposing to hypercalcaemia\r<br>\r<br>          -  Nephrolithiasis or renal insufficiency\r<br>\r<br>          -  Presence of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism in the\r<br>             year before the study began; a history of nephrolithiasis during the previous five\r<br>             years.\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis, Osteoporosis",
            "intervention": "Dietary Supplement: cholecalciferol;Dietary Supplement: calcium carbonate",
            "primary_outcome": "Changes in BMD over the 2 year study period comparing treatment and placebo groups",
            "secondary_outcome": "Cytokine expression following vitamin D supplementation;Contribution of vitamin D from different sources (generation in the skin, diet and supplements) to serum 25(OH) vitamin D (vitamin D status);Changes in parameters of lower extremity function over the 2 year study period;The number of relapses, the time to first relapse, the number of relapse-free patients;The number of patients without progression of disability judged by EDSS and;Reported infections;Ratings on a fatigue scale",
            "secondary_id": "EudraCT 2006-00427-11;MSvitD1",
            "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
        }
    ]
}