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=78",
    "previous": "http://api.gregory-ms.com/trials/?format=api&page=76",
    "results": [
        {
            "trial_id": 3558,
            "title": "A Phase I, sequential group, randomized, double-blind, placebo-controlled study to assess the tolerability and safety of escalating doses of oral laquinimod administered\r\ndaily in subjects with relapsing remitting multiple sclerosis (RRMS)",
            "summary": null,
            "published_date": "2009-04-21T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:19.912605Z",
            "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011234-99",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "euctr": "EUCTR2009-011234-99-DE"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "3785063",
            "last_refreshed_on": "2014-02-03",
            "scientific_title": "A Phase I, sequential group, randomized, double-blind, placebo-controlled study to assess the tolerability and safety of escalating doses of oral laquinimod administered\r\ndaily in subjects with relapsing remitting multiple sclerosis (RRMS) - MS-LAQ-101",
            "primary_sponsor": "Teva Pharmaceutical Industries Ltd",
            "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": "2009-06-23",
            "target_size": "160",
            "study_type": "Interventional clinical trial of medicinal product",
            "study_design": "Controlled: yes\nRandomised: yes\nOpen: no\nSingle blind: no\nDouble blind: yes\nParallel group: no\nCross over: no\nOther: yes\nOther trial design description: sequential group\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no\nNumber of treatment arms in the trial: 2",
            "phase": null,
            "countries": "Germany",
            "contact_firstname": "Dr. Matthias Roeckel",
            "contact_lastname": null,
            "contact_address": "Waldeckerstr. 7",
            "contact_email": "[email protected]",
            "contact_tel": "+4961059767643",
            "contact_affiliation": "Teva Pharma GmbH",
            "inclusion_criteria": "Inclusion criteria: <br>1. Subjects must have a confirmed and documented diagnosis of\r<br>Relapsing Remitting Multiple Sclerosis (RRMS), as defined by\r<br>the Revised McDonald criteria [Ann Neurol 2005: 58:840-846].\r<br>2. Subjects must have had experienced at least one documented\r<br>relapse in the 3 years prior to screening.\r<br>3. Subjects must be ambulatory with an EDSS score of 0-5.5 at\r<br>screening.\r<br>4. Subjects must be between 18 and 55 years of age, inclusive.\r<br>5. Subjects must be relapse-free and in a stable neurological\r<br>condition at least 30 days prior to screening.\r<br>6. Women of child-bearing potential must practice a highly\r<br>effective method of birth control [acceptable methods of birth\r<br>control in this study include: surgical sterilization, oral\r<br>contraceptive, contraceptive patch, long-acting injectable\r<br>contraceptive, hormonal intrauterine devices or partner's\r<br>vasectomy. Subjects using a non-hormonal IUD will be\r<br>required to use an additional hormonal or barrier method].\r<br>7. Subjects must be willing and able to give written informed\r<br>consent and comply with the protocol requirements for the\r<br>duration of the study.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 160<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range 0<br>",
            "exclusion_criteria": "Exclusion criteria: <br>1. An onset of relapse or any treatment with corticosteroids\r<br>(intravenous [iv], intramuscular [im] and/or per os [po]) or\r<br>ACTH between Day -7 (screening) and 0 (baseline).\r<br>2. Use of experimental or investigational drugs, and/or\r<br>participation in clinical drug studies within 6 months prior to\r<br>screening.\r<br>3. Use of immunosuppressive (including Mitoxantrone and\r<br>Natalizumab) or cytotoxic agents within 6 months prior to the\r<br>screening visit.\r<br>4. Previous use of laquinimod.\r<br>5. Treatment with glatiramer acetate (Copaxone®), Interferon\r<br>beta-1a (Avonex®, Rebif®), Interferon beta-1b (Betaseron®) or\r<br>IVIG within 1 month prior to screening visit.\r<br>6. A known history of tuberculosis.\r<br>7. Positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV antibody.\r<br>8. Use of inhibitors of CYP3A4 within 2 weeks prior to the\r<br>screening visit (3 weeks for fluoxetine).\r<br>9. Use of amiodarone within 2 years prior to screening visit.\r<br>10. Pregnancy or breastfeeding.\r<br>11. Subjects with a clinically significant or unstable medical or\r<br>surgical condition that would preclude safe and complete study\r<br>participation, as determined by medical history, physical\r<br>exams, ECG, laboratory tests or imaging. \r<br>12. Known hypersensitivity that would preclude administration of\r<br>laquinimod, such as to the following: mannitol, meglumine or\r<br>sodium stearyl fumarate.\r<br>13. The subject’s inability to give informed consent, or to complete\r<br>the study, or if the subject is considered by the investigator to\r<br>be, for any reason, an unsuitable candidate for this study.\r<br>14. Use of inducers of CYP3A4 within 2 weeks prior to the screening visit.<br>",
            "condition": "Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis (RRMS).\r\n\r\nThis study is planned to assess the tolerability and safety of escalating doses of oral\r\nlaquinimod administered daily in subjects with RRMS. <br>MedDRA version: 15.1\nLevel: PT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis\nSystem Organ Class: 10029205 - Nervous system disorders\n;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]",
            "intervention": "<br>Product Name: Laquinimod Capsules 0.6 mg<br>Product Code: TV-5600<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: laquinimod<br>CAS Number: 248282-07-7<br>Current Sponsor code: TV-5600<br>Other descriptive name: ABR-215062 sodium salt<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 0.6-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Product Name: Laquinimod Capsules 0.3 mg<br>Product Code: TV-5600<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: laquinimod<br>CAS Number: 248282-07-7<br>Current Sponsor code: TV-5600<br>Other descriptive name: ABR-215062 sodium salt<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 0.3-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>",
            "primary_outcome": "Main Objective: This study is aimed to assess the safety and tolerability profile of ascending doses<br>of laquinimod administered daily in subjects with RRMS, and is safety oriented in<br>nature; therefore, no formal hypothesis testing is planned.;Secondary Objective: Pharmacokinetic assessment.<br>The relationship between tolerability and safety measures and exposure may be assessed as deemed appropriate.;Primary end point(s): There is no primary endpoint in this study.<br><br>This study is aimed to assess the safety and tolerability profile of ascending doses<br>of laquinimod administered daily in subjects with RRMS, and is safety oriented in<br>nature; therefore, no formal hypothesis testing is planned.;Timepoint(s) of evaluation of this end point: There is no primary endpoint in this study.",
            "secondary_outcome": "Secondary end point(s): This study is aimed to assess the safety and tolerability profile of ascending doses\r<br>of laquinimod administered daily in subjects with RRMS, and is safety oriented in\r<br>nature; therefore, no formal hypothesis testing is planned.;Timepoint(s) of evaluation of this end point: This study is aimed to assess the safety and tolerability profile of ascending doses\r<br>of laquinimod administered daily in subjects with RRMS, and is safety oriented in\r<br>nature; therefore, no formal hypothesis testing is planned.",
            "secondary_id": "MS-LAQ-101",
            "source_support": "Teva Pharmaceutical Industries, Ltd",
            "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": 3557,
            "title": "Bayer/Cognitive Assessments With Multiple Sclerosis Subjects",
            "summary": null,
            "published_date": "2009-04-22T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:19.896167Z",
            "link": "http://clinicaltrials.gov/show/NCT00888277",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT00888277"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "4657377",
            "last_refreshed_on": "2015-02-19",
            "scientific_title": "Neuropsychological Assessments in the Multiple Sclerosis Clinic",
            "primary_sponsor": "University of Louisville",
            "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": "2009-05-28",
            "target_size": "74",
            "study_type": "Observational",
            "study_design": "Observational Model: Case-Only, Time Perspective: Prospective",
            "phase": "N/A",
            "countries": "United States",
            "contact_firstname": "",
            "contact_lastname": "Richard Kirzinger, MD",
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": "University of Louisville",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  EDSS at last visit = 7.0\r<br>\r<br>          -  Relapsing/Remitting or Secondary Progressive MS\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Severe Depressive Illness: Beck Depression Inventory Score > 55.\r<br>\r<br>          -  Unable to read with/without glasses- Visual Acuity better than or equal to 20/60 in\r<br>             one eye.\r<br>\r<br>          -  Unwilling to sign Informed Consent.\r<br>\r<br>          -  Evidence on clinical examination of severe dementia at discretion of evaluating\r<br>             neurologist.\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis, Relapsing-remitting;Multiple Sclerosis, Secondary Progressive",
            "intervention": null,
            "primary_outcome": "SDMT correlation with the findings on the Neuropsychological Battery. The Neuropsychological Battery will confirm that the SDMT is sensitive and specific in identifying MS patients with cognitive findings.",
            "secondary_outcome": "SDMT association with the BDI. The SDMT will be independent of depression.;Overlap of Depression with Cognitive Dysfunction. There will still be identified a high percentage of patients having both cognitive and depressive symptoms.;Lack of association of Cognitive Dysfunction with the Physical Scales of the EDSS.",
            "secondary_id": "OICN 090742;UofL IRB # 09.0167",
            "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": 3556,
            "title": "Study to investigate the combination of methylprednisolone and interferon-beta in the treatment of multiple sclerosis",
            "summary": null,
            "published_date": "2009-04-24T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:19.876930Z",
            "link": "http://isrctn.com/ISRCTN16202527",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "isrctn": "ISRCTN16202527"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "4539492",
            "last_refreshed_on": "2015-01-13",
            "scientific_title": "Nordic trial of methylprednisolone as add-on therapy to interferon-beta for the treatment of relapsing-remitting multiple sclerosis: a randomised, double-blind, placebo-controlled, parallel-group, multicentre trial",
            "primary_sponsor": "Danish Multiple Sclerosis Research Center (Denmark)",
            "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": "2003-08-25",
            "target_size": "300",
            "study_type": "Interventional",
            "study_design": "Randomised double-blind placebo-controlled parallel-group multicentre trial (Treatment)",
            "phase": null,
            "countries": "Denmark;Finland;Norway;Sweden",
            "contact_firstname": null,
            "contact_lastname": null,
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": null,
            "inclusion_criteria": "Inclusion criteria: 1. Males and females between the age of 18 and 55 years (both included)<br>2. Has multiple sclerosis according to the McDonald criteria and suffers from clinically definite relapsing-remitting MS according to the Poser criteria<br>3. Has a disability equivalent to Expanded Disability Status Scale (EDSS) of 5.5 or less<br>4. Has been on treatment with IFN-beta-1a (Rebif®) for at least 1 year and has received IFN-beta-1a (Rebif®) 44 µg three times weekly for at least 1 month<br>5. Has shown clinical activity defined as at least one relapse during the previous 12 months and thereby is classified as a patient with partial treatment response. A historical relapse may be accepted as qualifying as judged by the treating physician.<br>6. Is prepared to and considered able to follow the protocol during the whole study period and to attend the planned visits<br>7. Female of childbearing potential must use adequate contraceptive methods and must have negative pregnancy test results<br>8. Has given written informed consent",
            "exclusion_criteria": "Exclusion criteria: 1. Has received treatment with lymphoid irradiation, mitoxantrone, cyclophosphamide, or long-term systemic glucocorticoids<br>2. Has received treatment with azathioprine, cyclosporine, glatiramer acetate, or other immunosuppressive agents or intravenous immunoglobulin within 6 months prior to inclusion in the study<br>3. Has changed IFN-beta preparation or dose within 3 months of inclusion in the study<br>4. Has received treatment with systemic glucocorticoids (relapse treatment) or adrenocorticotropic hormone (ACTH) within 8 weeks prior to inclusion in the study<br>5. Has experienced a relapse within one month prior to the inclusion in the study<br>6. Has converted to secondary progressive MS<br>7. Has a history of peptic ulcer or present symptoms of dyspepsia<br>8. Has suffered from major depression or any other psychiatric disorder that would preclude safe participation in the study<br>9. Has diabetes mellitus<br>10. Has alcohol or drug abuse<br>11. Has cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischaemic heart disease (New York Heart Association [NYHA] Functional Classification III or IV), or malignant hypertension<br>12. Has renal insufficiency<br>13. Has aspartate aminotransferase (ASAT) greater than 2.5 x normal upper limit<br>14. Has leucopenia less than 2500 leucocytes per microlitre or thrombocytopenia less than 100,000 thrombocytes per microlitre<br>15. Has any medical illness requiring treatment with systemic corticosteroids<br>16. Has any systemic disease, which can influence his/her safety and compliance, or the evaluation of the disability<br>17. Has formerly shown severe reactions against corticosteroids<br>18. Is pregnant or breast-feeding<br>19. Has epilepsy not under control by anti-epileptic drug (AED)",
            "condition": "Relapsing-remitting multiple sclerosis <br>Nervous System Diseases <br>Multiple sclerosis",
            "intervention": "Methylprednisolone 100 mg tablets or identically appearing placebo tablets. Dose and administration: 2 tablets after the morning meal on 5 consecutive days at 4-week intervals for at least 96 weeks (extension to 144 weeks possible).",
            "primary_outcome": "The mean number of documented relapses per patient per year at 96 weeks. A documented relapse was defined as the appearance of a new or worsening of old neurological symptoms or signs, in the absence of fever, persisting for more than 48 hours and causing objective changes on neurological examination and preceded by a period of more than 30 days with a stable or improving condition. Changes in bowel and bladder or cerebral functions should not have been solely responsible for a relapse.",
            "secondary_outcome": "1. The mean number of documented relapses per patient per year at 48 weeks<br>2. The occurrence of neutralising antibodies at 96 weeks<br>3. Changes in the Multiple Sclerosis Functional Composite (MSFC) score<br>4. The time to a permanent increase in disability of 1.0 point as measured by the Extended Disability Status Score (EDSS) and confirmed at 2 consecutive visits with an interval of 24 weeks<br>5. The number of active lesions (new or enlarging lesions) on T2 weighted magnetic resonance imaging (MRI)",
            "secondary_id": "N/A",
            "source_support": "Merck Serono (Denmark) - non-conditional grant; investigator-initiated and investigator-driven study",
            "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": 3555,
            "title": "Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis",
            "summary": null,
            "published_date": "2009-04-24T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:19.859566Z",
            "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002626-11",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "euctr": "EUCTR2008-002626-11-SE"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "6333033",
            "last_refreshed_on": "2017-07-24",
            "scientific_title": "Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis - PMSIT",
            "primary_sponsor": "Dept of Neurology",
            "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": "2009-02-07",
            "target_size": null,
            "study_type": "Interventional clinical trial of medicinal product",
            "study_design": "Controlled: no\nRandomised: no\nOpen: no\nSingle blind: no\nDouble blind: no\nParallel group: no\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: no\nOther: no",
            "phase": "Human pharmacology (Phase I): no\nTherapeutic exploratory (Phase II): yes\nTherapeutic confirmatory - (Phase III): no\nTherapeutic use (Phase IV): no",
            "countries": "Sweden",
            "contact_firstname": null,
            "contact_lastname": null,
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": null,
            "inclusion_criteria": "Inclusion criteria: <br>A subject will be eligible for inclusion in this study if all of the following criteria apply:<br><br>•\tBetween the age of 18 and 65 years of age<br>•\tProgressive MS since at least three years<br>•\tSome kind of documented progression of neurological symptoms during the previ-ous two years.<br>•\tEDSS 4,0 - 7.0 (inclusive) (basically spared arm functions)<br>•\tConventional therapy not indicated, contraindicated or failed<br>•\tJudged as compliant with the protocol<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 30<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>A subject will not be eligible for inclusion in this study if any of the following criteria ap-plies:<br><br>•\tEligible for any of the conventional MS therapies<br>•\tRRMS<br>•\tBleeding diathesis or medication contraindicating neurosurgical procedures or lumbar puncture<br>•\tCognitive defect making informed consent unreliable<br>•\tAny medidal condition contraindicating minor surgical procedures, as judged by anaesthesiologist<br>•\tSevere uncontrolled heart disease<br>•\tPregnant or lactating women<br>•\tPatients having contraindication for or otherwise not compliant with MRI investigations<br>•\tDocumented vulnerability to infections<br>•\tSimultaneous treatment with other immunosuppressive drugs<br>•\tDocumented allergy or intolerance to Rituximab<br>•\tSevere psychiatric condition<br><br>",
            "condition": "Severe progressive multiple sclerosis in which there is no other documented treatment avalilable or allready tested. It is estimated that the prognosis for these patients are poor without any effective treatment <br>MedDRA version: 14.1\nLevel: PT\nClassification code 10028245\nTerm: Multiple sclerosis\nSystem Organ Class: 10029205 - Nervous system disorders",
            "intervention": "<br>Trade Name: Mabthera<br>Pharmaceutical Form: Concentrate for solution for infusion<br>Other descriptive name: RITUXIMAB<br><br>",
            "primary_outcome": "Main Objective: Investigate tolerability and efficacy of intrathecally administered Mabthera in severe progressive MS where there is no available effective treatment;Secondary Objective: Investigate the effects on immune parameters and magnetic resonance imaging of the treatment;Primary end point(s): The primary endpoint is to document safety parameters during the study<br>The secondary endpoints are clinical variables, ie stabilization of the disease, measured as tes for both leg, arm and cognitiv functions<br>another secondary and exploratory endpoint is by analysing biomarkers and lymfocyte subsets in the CSF and blood to document expected biological effects of the treatment.<br>",
            "secondary_outcome": null,
            "secondary_id": "ITT-PMS",
            "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": 3554,
            "title": "'Getting the Balance Right' - A comparison of physiotherapy and exercise treatments for people with multiple sclerosis (MS)",
            "summary": null,
            "published_date": "2009-04-30T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:19.841070Z",
            "link": "http://isrctn.com/ISRCTN77610415",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "isrctn": "ISRCTN77610415"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "4531768",
            "last_refreshed_on": "2015-01-13",
            "scientific_title": "A randomised controlled trial of physiotherapy and exercise interventions for ambulatory people with multiple sclerosis (MS)",
            "primary_sponsor": "University of Limerick (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": "2008-01-04",
            "target_size": "328",
            "study_type": "Interventional",
            "study_design": "Cluster-randomised single-blind multi-centre trial  (Treatment)",
            "phase": null,
            "countries": "Ireland",
            "contact_firstname": null,
            "contact_lastname": null,
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": null,
            "inclusion_criteria": "Inclusion criteria: 1. Both males and females, aged >=18<br>2. Diagnosis of MS confirmed by their consultant physician or neurologist<br>3. Resident in the republic of Ireland",
            "exclusion_criteria": "Exclusion criteria: 1. Currently experiencing an exacerbation of symptoms due to relapse<br>2. Patients who have had steroid treatment within 3 months of the baseline measurement<br>3. Pregnant at time of referral<br>4. Under 18 years of age",
            "condition": "Multiple sclerosis (MS) <br>Nervous System Diseases <br>Multiple sclerosis",
            "intervention": "The physiotherapy interventions for strands A and B are standardised and based on the latest evidence for practice in order to allow reproduction of the programmes. The yoga and fitness instructor interventions are not specified, in order to represent normal practice, but are well documented to allow comparison later. <br><br>To ensure standardisation of physiotherapy interventions, training for those physiotherapists delivering the programmes will be held on three occasions, supporting documentation will be provided and follow up advice and information for deliverers will be supplied as necessary by email and telephone. The content of the interventions for both strands is described below. The attendance and participation of each study participant will be documented on a weekly basis. <br><br>The control groups in both strands will not receive any intervention for the 12 weeks and were told to continue with their normal routine. Once the control period is over participants will receive the treatment of their choice but the response to this will not be assessed as part of this trial. <br><br>Strand A: <br><br>Intervention 1: Physiotherapy led strength and aerobic training <br>Participants will attend an hour long circuit class once a week for 10 weeks. This will be a circuit style class consisting of \"sit to stand\" / squat, bridging, resisted shoulder flexion, walking / bike, resisted elbow flexion, lunges or resisted knee extension, hip extension, calf raises. All exercises will be completed at 50-80% of the participants' one-repetition-maximum and the load will be increased by 2-5% when twelve repetitions are easily achieved. The aim is for the participant to be failing on the last repetition. If the next available load is higher than 2-5% (such as going from 1 kg to 2 kg in resisted shoulder flexion) the participant can increase the repetitions so that they are still failing to achieve full range on motion on the last one. The primary aim is to achieve 'overload' of the muscle to achieve",
            "primary_outcome": "Multiple Sclerosis Impact Scale 29, v2<br><br>All primary and secondary outcomes will be assessed at the following timepoins: Week 1, (before intervention), week 12 (after intervention/control period) and week 24 (follow-up)",
            "secondary_outcome": "1. Muscle strength using hand held dynamometry<br>2. Modified Ashworth Scale<br>3. Physiological Cost Index<br>4. Six-minute walking test<br>5. Berg Balance Scale<br>6. Modified Fatigue Impact Scale <br><br>All primary and secondary outcomes will be assessed at the following timepoins: Week 1, (before intervention), week 12 (after intervention/control period) and week 24 (follow-up)",
            "secondary_id": "N/A",
            "source_support": "Multiple Sclerosis Society of Ireland (MS Ireland) (Ireland) - through Tesco (UK) 'Charity of the Year' funding, Pobal (Ireland) - Dormant Accounts Flagship Fund",
            "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": 3553,
            "title": "BEYOND Pilot Study",
            "summary": null,
            "published_date": "2009-04-05T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:19.821827Z",
            "link": "http://clinicaltrials.gov/show/NCT00893217",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT00893217"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "4657747",
            "last_refreshed_on": "2015-02-19",
            "scientific_title": "Double-blind, Randomized, Parallel Group, Multicenter Study of the Safety and Tolerability of Betaseron 500 Mcg Subcutaneously Every Other Day and Betaseron 250 Mcg Subcutaneously Every Other Day for at Least 12 Weeks in Patients With RRMS",
            "primary_sponsor": "Bayer",
            "retrospective_flag": "No",
            "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": "2002-11-28",
            "target_size": "71",
            "study_type": "Interventional",
            "study_design": "Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment",
            "phase": "Phase 2",
            "countries": "United States",
            "contact_firstname": "",
            "contact_lastname": "Bayer Study Director",
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": "Bayer",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>        Diagnosis of RRMS as defined by any of the following McDonald diagnostic criteria\r<br>        (McDonald et al 2001; see Appendix 16.1.1 [(Protocol Appendix 5]):\r<br>\r<br>          -  Two relapses and objective clinical evidence (history or present) of at least 2\r<br>             lesions\r<br>\r<br>          -  Two relapses and objective clinical evidence (history or present) of 1 lesion; and\r<br>             dissemination in space, demonstrated by MRI (Barkhof/Tintoré criteria) or 2 MRI T2\r<br>             lesions consistent with MS plus positive CSF.\r<br>\r<br>          -  One relapse with objective clinical evidence (history or present) of at least 2\r<br>             lesions, and dissemination in time, demonstrated signs of disease activity ( new Gd+\r<br>             lesion or new T2 lesion) in an MRI scan at least 3 months after the onset of that\r<br>             clinical event.\r<br>\r<br>          -  One relapse and objective clinical evidence (history or present) of 1 lesion, and\r<br>             dissemination in space, demonstrated by MRI (Barkhof/Tintoré criteria); or 2 MRI T2\r<br>             lesions consistent with MS plus positive CSF, and dissemination in time, demonstrated\r<br>             by signs of disease activity (new Gd+ lesion or new T2 lesion) in an MRI scan at\r<br>             least 3 months after the onset of that clinical event.\r<br>\r<br>               -  18 to 55 years of age\r<br>\r<br>               -  Score of 0-5.5 on the Kurtzke Expanded Disability Status Scale' (EDSS; see\r<br>                  Appendix 16.1.1 [Protocol Appendix 4])\r<br>\r<br>               -  Naïve to immunomodulating therapies or previously treated with immunomodulating\r<br>                  therapies other than any interferon (IFN) more than 30 days prior to the start\r<br>                  of the study\r<br>\r<br>               -  If female of child-bearing potential, agreement to practice adequate\r<br>                  contraception methods (IUCD, condoms, oral contraceptives, or other adequate\r<br>                  barrier contraception)\r<br>\r<br>               -  Negative serum pregnancy test results.\r<br>\r<br>               -  Signed and dated statement of informed consent\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Clinically significant heart disease such as uncontrolled cardiac dysrhythmia, angina\r<br>             pectoris, cardiomyopathy, or congestive heart failure\r<br>\r<br>          -  History of severe depression, suicide attempts, or current suicidal ideations\r<br>\r<br>          -  Clinically significant liver, renal, and bone marrow dysfunction as defined by any of\r<br>             the following laboratory evaluations:\r<br>\r<br>          -  bone marrow dysfunction:\r<br>\r<br>               -  Hb <8.5 g/dl\r<br>\r<br>               -  WBC <2.5 x 109/L\r<br>\r<br>               -  platelet count <125 x 109/L\r<br>\r<br>          -  renal dysfunction: creatinine >1.8 mg/dL\r<br>\r<br>          -  liver dysfunction:\r<br>\r<br>               -  ASAT (SGOT) >3xupper limit of normal\r<br>\r<br>               -  bilirubin >2x upper limit of normal\r<br>\r<br>          -  Epilepsy not adequately controlled by treatment\r<br>\r<br>          -  Any conditions that could interfere with the MRI or any other evaluation in the study\r<br>\r<br>          -  Known allergy to human proteins including albumin and IFN, or to mannitol or\r<br>             gadolinium\r<br>\r<br>          -  Participation in any clinical study within the past 30 days or use/intake of an\r<br>             investigational drug within the last 3 months prior to study entry\r<br>\r<br>          -  Prior treatment with monoclonal antibody therapy, cladribine or total lymphoid\r<br>             irradiation\r<br>\r<br>          -  Treatment with cytotoxic or immunosuppressive therapies (except systemic steroid or\r<br>             adrenocorticotropic hormone [ACTH]) within 6 months prior to study entry; or systemic\r<br>             steroid or ACTH within 1 month prior to study entry\r<br>\r<br>          -  Presence of monoclonal gammopathy\r<br>\r<br>          -  Inability to tolerate both NSAIDs and acetaminophen\r<br>\r<br>          -  Pregnancy or lactation\r<br>\r<br>          -  History of alcohol or drug abuse\r<br>\r<br>          -  Inability to administer subcutaneous injections either by self or by caregiver\r<br>\r<br>          -  Medical, psychiatric or other conditions that compromise the patient's ability to\r<br>             give informed consent, to understand the patient information, to comply with the\r<br>             study protocol, or to complete the study\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis;Relapsing-Remitting",
            "intervention": "Drug: Betaseron (Interferon beta-1b, BAY86-5046);Drug: Betaseron (Interferon beta-1b, BAY86-5046)",
            "primary_outcome": "To evaluate the safety and tolerability of IFNB-1b 500 mcg given subcutaneously (SC) QOD compared with the standard dose of 250 mcg QOD in patients with RRMS.",
            "secondary_outcome": null,
            "secondary_id": "BEYOND pilot;307000;91232",
            "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": 3552,
            "title": "Zoledronate to prevent bone loss in acute multiple sclerosis",
            "summary": null,
            "published_date": "2009-05-05T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:19.803651Z",
            "link": "http://isrctn.com/ISRCTN87039596",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "isrctn": "ISRCTN87039596"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "4539428",
            "last_refreshed_on": "2015-01-13",
            "scientific_title": "A randomised controlled trial to evaluate whether zoledronate prevents bone loss in acute multiple sclerosis",
            "primary_sponsor": "North Bristol NHS Trust (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": "2009-04-20",
            "target_size": "40",
            "study_type": "Interventional",
            "study_design": "Single-blind randomised two-arm placebo-controlled 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. Aged 18 - 65 years (either sex) with a diagnosis of multiple sclerosis (MS)<br>2. Acute flare up requiring treatment with a corticosteroid<br>3. Able to attend for study investigations and assessments<br>4. Willing and able to provide informed consent",
            "exclusion_criteria": "Exclusion criteria: 1. Previous diagnosis of osteoporosis<br>2. Bone therapy within previous 12 months<br>3. Previous bisphosphonate therapy at any time<br>4. Associated disorder that may affect bone metabolism<br>5. Pregnancy<br>6. Breastfeeding",
            "condition": "Multiple sclerosis <br>Nervous System Diseases <br>Multiple sclerosis",
            "intervention": "A single dose of intravenous zoledronate 5 mg/placebo prior to commencement of intravenous corticosteroid for acute exacerbation of multiple sclerosis symptoms. Blood samples taken on days 1, 2, 3, 7, 90, 180 and 360. Dual energy X-ray absorptiometry (DXA) scans taken on day 7, 90, 180 and 360.<br><br>Updated 11/08/2014: this trial was halted prematurely due to problems with recruitment.",
            "primary_outcome": "A significant difference in serum type I collagen C-telopeptides (CTX) according to treatment group at day 7 of the study",
            "secondary_outcome": "Increased bone mineral density (BMD), measured at days 7, 90,180 and 360",
            "secondary_id": "CZOL446HGB15T",
            "source_support": "Novartis Pharmaceuticals (UK)",
            "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": 3551,
            "title": "Trichuris suis Ova Therapy for Relapsing Multiple Sclerosis - a safety study - TRIMS A",
            "summary": null,
            "published_date": "2009-06-05T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:19.786828Z",
            "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-007549-29",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "euctr": "EUCTR2008-007549-29-DK"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "11224219",
            "last_refreshed_on": "2021-08-02",
            "scientific_title": "Trichuris suis Ova Therapy for Relapsing Multiple Sclerosis - a safety study - TRIMS A",
            "primary_sponsor": "Danish Multiple Sclerosis Research Center",
            "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": "2009-09-06",
            "target_size": "10",
            "study_type": "Interventional clinical trial of medicinal product",
            "study_design": "Controlled: no<br>Randomised: no<br>Open: no<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: <br>If controlled, specify comparator, Other Medicinial Product: <br>Placebo: <br>Other: <br>",
            "phase": "Human pharmacology (Phase I): no\nTherapeutic exploratory (Phase II): yes\nTherapeutic confirmatory - (Phase III): no\nTherapeutic use (Phase IV): no",
            "countries": "Denmark",
            "contact_firstname": null,
            "contact_lastname": null,
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": null,
            "inclusion_criteria": "Inclusion criteria: <br>?\tage between 19 and 55 years<br>?\trelapsing course of multiple sclerosis (relapsing-remitting or secondary progressive  MS with relapses)<br>?\tduration of the disease of at least 1 year<br>?\tEDSS ? 5.5 (expanded disability scale – see Appendix B and C)<br>?\tno disease modifying therapy or unchanged immunomodulatory therapy for the last 3 months<br>?\tat least 2 documented relapses during the last 24 months with the last relapse within the last 6 months or at least 1 documented relapse during the last 24 months with at least one Gadolinium positive lesion on a screening MRI.  <br>?\tnine or more focal brain lesions on MRI according to the Barkhof criteria<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>?\tpregnancy or period of breastfeeding or missing adequate contraceptive protection for female premenopausal patients<br>?\trelapse in the last month prior enrolment<br>?\ttreatment with steroids in the last 30 days <br>?\tprevious treatment with mitoxantrone, cyclophosphamide or other intensive immunosupression, total irradiation or any kind of experimental therapy<br>?\ttreatment with glatiramer acetate, azathioprine, IVIG or any other immunosuppressive or immunomodulatory drug apart from interferon-beta in the 6 months prior to enrolment<br>?\tcardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (CCS III or IV), malignant hypertension <br>?\tdiabetes mellitus and other autoimmune diseases<br>?\thistory of renal insufficiency<br>?\tstay in tropical areas during the last 3 months<br>?\teosinophilia in the blood (> 0,45 billion/l)<br>?\tconcurrent systemic infections such as hepatitis B virus, hepatitis C virus, HIV and other infections which the investigator might find relevant.<br><br>",
            "condition": "Relapsing Multipel Sclerosis <br>MedDRA version: 12.0\nLevel: LLT\nClassification code 10028245\nTerm: Multiple sclerosis\n <br>MedDRA version: 12.0\nLevel: LLT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis\n <br>MedDRA version: 12.0\nLevel: LLT\nClassification code 10053395\nTerm: Progressive multiple sclerosis",
            "intervention": "<br>Product Name: Trichuris suis Ova<br>Product Code: TSO<br>Pharmaceutical Form: Oral suspension<br>INN or Proposed INN: Trichuris suis eggs<br>Current Sponsor code: Trichuris suis eggs<br>Other descriptive name: Trichuris suis eggs<br>Concentration unit: thousand organisms/ml thousand organisms/millilitre<br>Concentration type: range<br>Concentration number: 0,15-0,183<br><br>",
            "primary_outcome": "Main Objective: To evaluate safety of TSO in the treatment of relapsing Multipel Sclerosis patients;Secondary Objective: ;Primary end point(s): ?\tStandard safety parameters including adverse events, clinical laboratory tests and vital signs<br>?\tMRI scans <br>?\tRelapses<br>",
            "secondary_outcome": null,
            "secondary_id": "2008-229",
            "source_support": null,
            "ethics_review_status": "Approved",
            "ethics_review_approval_date": "2009-09-06",
            "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": 3550,
            "title": "A prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMER",
            "summary": null,
            "published_date": "2009-12-05T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:19.767974Z",
            "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-009503-19",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "euctr": "EUCTR2009-009503-19-BE"
            },
            "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": "6349314",
            "last_refreshed_on": "2017-08-21",
            "scientific_title": "A prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMER",
            "primary_sponsor": "Biogen Idec International GmbH",
            "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": "2010-07-20",
            "target_size": "200",
            "study_type": "Interventional clinical trial of medicinal product",
            "study_design": "Controlled: no\nRandomised: \nOpen: \nSingle blind: \nDouble blind: \nParallel group: \nCross over: \nOther: \nIf controlled, specify comparator, Other Medicinial Product: \nPlacebo: \nOther:",
            "phase": "Human pharmacology (Phase I): no\nTherapeutic exploratory (Phase II): no\nTherapeutic confirmatory - (Phase III): no\nTherapeutic use (Phase IV): yes",
            "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. Must give written informed consent and provide all authorizations required by local law (e.g., Protected Health Information [PHI])<br>2. Men or women between 18 and 60 years of age, inclusive<br>3. Must have EDSS = 5.5 at baseline.<br>4. Must be able to walk at least 100m without assistive devices<br>5. Must be natalizumab naïve<br>6. Must have a documented diagnosis of a relapsing remitting form of MS as defined by the revised McDonald Committee criteria (Polman, 2005)<br>7. Must have had a recent MRI (within 3 months from baseline)<br>8. Must have had at least 1 relapse in the previous year and must satisfy the locally approved therapeutic indications for TYSABRI®. If TYSABRI®  is not yet approved in a specific country, patients must fulfill the following criteria:<br>•  Patients with high disease activity despite treatment with a beta-interferon defined as patients who have failed to respond to a full and adequate course of a beta-interferon. Patients must have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gd-enhancing lesion. <br>Or <br>•  Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined as patients who have had 2 or more disabling relapses in one year and 1 or more Gd-enhancing lesions on brain MRI or significant increase in T2 lesions as compared to a previous MRI<br>9. Must be stable in disability for at least 30 days prior to enrollment to the study<br>10. Must be stable in symptomatic management of the disease, specifically spasticity, depression and fatigue for at least 30 days prior to enrollment to the study<br>11. Must be considered by the Investigator to be free of signs and symptoms suggestive of PML based on medical history, physical examination, or laboratory testing.<br>12. Must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN beta and GA) while being treated with natalizumab during the study<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>Medical History:<br>1. Onset of a relapse within 50 days prior to first infusion<br>2. Considered by the Investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing or due to prior immunosuppressive treatment<br>3. History of, or available abnormal laboratory results indicative of, any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric (including major depression), renal, and/or other major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent.  The Investigator must re-review the subject’s medical fitness for participation and consider any diseases that would preclude treatment.<br>4. History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible)<br>5. Known history of human immunodeficiency virus infection or hematological malignancy<br>6. History of organ transplantation (including anti-rejection therapy)<br>7. A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to the Screening Visit.<br><br>Treatment History:<br>8. Treatment with immunosuppressant medications (e.g., mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate) within 6 months prior to Screening<br><br>Miscellaneous<br>9. Female subjects who are not postmenopausal for at least 1 year, surgically sterile (does not include tubal ligation), or willing to practice effective contraception (as defined by the Investigator) during the study <br>10. Women who are breastfeeding, pregnant, or planning to become pregnant while on study<br>11. Current enrollment in any other study treatment or disease study<br>12. Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol<br>13. Subjects with walking impairment due to causes other than MS<br>14. Other unspecified reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment into this study.<br><br>",
            "condition": "Multiple sclerosis <br>MedDRA version: 9.1\nLevel: LLT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis",
            "intervention": "<br>Trade Name: Tysabri<br>Pharmaceutical Form: Concentrate for solution for infusion<br>INN or Proposed INN: Natalizumab<br>Current Sponsor code: BG00002<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 300-<br><br>",
            "primary_outcome": "Main Objective: To evaluate the evolution of walking capacity as measured by T100T, T25FW, MWD and EDSS during the first year of therapy with natalizumab;Secondary Objective: To evaluate the correlation between the MWD and EDSS and both walking tests, the T100T and the T25FW at baseline, at 6 months and at 1 year of therapy.<br><br>To determine how well each of the walking tests, T100T or T25FW, predicts walking limitations in all subjects and in the subgroups of subjects stratified by baseline EDSS. ;Primary end point(s): The primary endpoint of the study is the evolution of walking abilities as measured by MWD, EDSS, T25FW and T100T during the first year of therapy with natalizumab.",
            "secondary_outcome": null,
            "secondary_id": "TYS-IMA-08-11",
            "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": 3549,
            "title": "Injection Management With Betaferon: Influence on Adherence, Patients Satisfaction and Health Related Outcomes (BETAPATH)",
            "summary": null,
            "published_date": "2009-05-13T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:19.750908Z",
            "link": "https://clinicaltrials.gov/show/NCT00902135",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT00902135"
            },
            "categories": [],
            "export_date": "2024-03-28T00:00:00Z",
            "internal_number": "5007263",
            "last_refreshed_on": "2015-08-03",
            "scientific_title": "Betaferon® Injection Management: Non-interventional Study on Personal Digital Assistant (PDA)Supported Effects on Adherence to a Long-term Injection Therapy (BETAPATH)",
            "primary_sponsor": "Bayer",
            "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": "2009-05-28",
            "target_size": "702",
            "study_type": "Observational",
            "study_design": "Observational Model: Cohort, Time Perspective: Prospective",
            "phase": "N/A",
            "countries": "Germany",
            "contact_firstname": "",
            "contact_lastname": "Bayer Study Director",
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": "Bayer",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Outpatients with the diagnosis of Multiple Sclerosis and decision by the investigator\r<br>             to prescribe Betaferon.The decision for treatment type and duration is taken before\r<br>             offering the patient the possibility to participate in the study.\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Patients, who do not meet the Clinically Isolated Syndrome (CIS) or\r<br>             Relapsing/Remitting Multiple Sclerosis (RRMS) criteria, should not be included.\r<br>\r<br>          -  Exclusion criteria must be read in conjunction with the German product information.\r<br>",
            "exclusion_criteria": null,
            "condition": "Relapsing-Remitting Multiple Sclerosis",
            "intervention": "Drug: Interferon beta-1b (Betaseron, BAY86-5046);Drug: Interferon beta-1b (Betaseron, BAY86-5046);Drug: Interferon beta-1b (Betaseron, BAY86-5046)",
            "primary_outcome": "Drop out rate over 2 years",
            "secondary_outcome": "Disability status;Grade of depressiveness;Grade of fatigue;Quality of life;Cognitive status;Injection regularity",
            "secondary_id": "BF0801DE;14543",
            "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
        }
    ]
}