Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-04 @ 12:16 PM
Study NCT ID:
NCT00190268
Status:
COMPLETED
Last Update Posted:
2011-02-21
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D005221', 'term': 'Fatigue'}], '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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077770', 'term': 'Amifampridine'}], 'ancestors': [{'id': 'D015761', 'term': '4-Aminopyridine'}, {'id': 'D000631', 'term': 'Aminopyridines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-18', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2011-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.', 'timeFrame': '43 months', 'description': 'improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.'}], 'secondaryOutcomes': [{'measure': 'evaluation of safety', 'timeFrame': '43 months', 'description': 'evaluation of safety'}, {'measure': 'quality of life impact', 'timeFrame': '43 months', 'description': 'quality of life impact'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'fatigue', '3,4-diaminopyridine'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': "Rational of study : 3,4-diaminopyridine is suspected to improved the fatigue associated in patient's multiple sclerosis.\n\nIn order to confirm this hypothesis, a randomized, controlled versus placebo, double blinded study is performed.", 'detailedDescription': 'We proposed a randomized controlled trial between 3,4-diaminopyridine and placebo .\n\nThe main objective : improvement of fatigue by diminution of EMIF-SEP score between the arm treatment and placebo arm. The hypothesis tested is that the 3,4-DAP is efficacy in the fatigue of multiple sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years and = \\<60 years\n* Patients with multiple sclerosis clinically defined and with MIFS-SEP score \\> 44, without deficit sleep and without depression.\n* Patients without treatment by 3,4-DAP since 3 months\n* EDSS score \\< 6\n\nExclusion Criteria:\n\n* ASAT/ALAT \\> 2 x ULN\n* MADRS \\>= 20\n* Abnormality cardiac rhythm\n* Pregnancy\n* Asthma\n* Evolutive affection\n* Renal failure'}, 'identificationModule': {'nctId': 'NCT00190268', 'briefTitle': 'Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis', 'nctIdAliases': ['NCT00169429'], 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Multicentric Study, Comparative, Randomized, in Double Knowledge of the Effectiveness (Versus Placebo) of a Salt Of 3,4 - Diaminopyridine in the Treatment of Tiredness During the Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'P020304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3,4-diaminopyridine', 'description': '3,4-diaminopyridine', 'interventionNames': ['Drug: 3,4-diaminopyridine']}], 'interventions': [{'name': '3,4-diaminopyridine', 'type': 'DRUG', 'description': '3,4-diaminopyridine', 'armGroupLabels': ['3,4-diaminopyridine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Henri Mondor Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Pitié Salpetriere Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Tenon Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Pontchaillou Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Pierre Cesaro, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hopital Henri Mondor-France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Isabelle BRINDEL', 'oldOrganization': 'Department of Clinical Research of developpement'}}}}