Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-29 @ 1:16 PM
Study NCT ID:
NCT00217295
Status:
UNKNOWN
Last Update Posted:
2005-09-22
First Post:
2005-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068556', 'term': 'Interferon beta-1a'}, {'id': 'D000077236', 'term': 'Topiramate'}], 'ancestors': [{'id': 'D016899', 'term': 'Interferon-beta'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-06', 'completionDateStruct': {'date': '2007-12'}, 'lastUpdateSubmitDate': '2005-09-14', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability'}], 'secondaryOutcomes': [{'measure': 'Brain atrophy on nMRI'}, {'measure': 'Disease progression on EDSS and MSFC'}, {'measure': 'Relapse rate'}]}, 'conditionsModule': {'keywords': ['Relapsing-remitting multiple sclerosis', 'Brain atrophy', 'Disease progression'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This is a clinical trial in relapsing-remitting Multiple Sclerosis to determine if Topamax added to Avonex has a neuroprotective effect as measured by the brain parenchymal fraction ( a measure of brain shrinkage) and by clinical assessment scores to evaluate disease progression.', 'detailedDescription': "The protocol requires all participants to be treated with Avonex and in addition patients will be blindly assigned to either a group who receive Topamax or a placebo control. Repeated neurological and clinical examinations are performed with laboratory tests to determine any possible adverse drug effects. The scaled neurologic examinations (EDSS and MSFC) and brain MRI's are done at regular intervals to evaluate possible treatment effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRelapsing-remitting multiple sclerosis\n\n\\-\n\nExclusion Criteria:\n\nSecondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -'}, 'identificationModule': {'nctId': 'NCT00217295', 'briefTitle': 'A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Multiple Sclerosis Institute'}, 'officialTitle': 'A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis.', 'orgStudyIdInfo': {'id': 'MSI-101'}, 'secondaryIdInfos': [{'id': 'BiogenIdec'}, {'id': 'Ortho-McNeil'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Avonex and Topamax', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19146', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey I Greenstein, MD', 'role': 'CONTACT', 'phone': '215-985-2245'}, {'name': 'Iris J Gold, MBA', 'role': 'CONTACT', 'phone': '215-985-2245'}, {'name': 'Jeffrey I Greenstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Multiple Sclerosis Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Jeffrey I Greenstein, MD', 'role': 'CONTACT', 'phone': '215-985-2245'}], 'overallOfficials': [{'name': 'Jeffrey I Greenstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MSI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Multiple Sclerosis Institute', 'class': 'OTHER'}}}}