Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT00811902
Status:
COMPLETED
Last Update Posted:
2016-02-26
First Post:
2008-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C101289', 'term': 'nerispirdine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 405}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'dispFirstSubmitDate': '2016-01-28', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-28', 'studyFirstSubmitDate': '2008-12-18', 'dispFirstSubmitQcDate': '2016-01-28', 'studyFirstSubmitQcDate': '2008-12-18', 'dispFirstPostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT)', 'timeFrame': '14 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12)', 'timeFrame': '14 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple sclerosis'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess the activity of nerispirdine in improving the ability to walk, in patients with multiple sclerosis (MS).\n\nSecondary objectives:\n\n* To assess other measures of walking ability, tiredness, and lower limb muscular strength, spasticity, clinical assessment by subject and clinical assessment of change by the Study Investigator\n* To assess the safety and tolerance of nerispirdine\n* To evaluate the pharmacokinetics (PK) parameters of nerispirdine', 'detailedDescription': 'Total duration per patient is approximately 19 weeks in total, comprising a 3-week screening period inclusive of a 2-week placebo run-in period, a 14-week treatment period, and a 2-week placebo run-out (follow-up) period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically definite MS (according to McDonald criteria),\n\nExclusion Criteria:\n\n* Multiple sclerosis exacerbation or clinical relapse within 6-month prior to the screening visit.\n* Subject who is not able to complete two trials of a timed 25 foot walk, with or without an assisted device,\n* Patients without valid V1, V2, and V4 T25-FW measurements are not eligible for randomization.\n* Female patients who are either pregnant or breastfeeding.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00811902', 'briefTitle': 'Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients With Multiple Sclerosis.', 'orgStudyIdInfo': {'id': 'DRI10566'}, 'secondaryIdInfos': [{'id': '2008-001999-67', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nerispirdine 50mg', 'description': 'Nerispirdine 50mg once daily for 14 weeks', 'interventionNames': ['Drug: Nerispirdine']}, {'type': 'EXPERIMENTAL', 'label': 'Nerispirdine 100mg', 'description': 'Nerispirdine 100mg once daily for 14 weeks', 'interventionNames': ['Drug: Nerispirdine']}, {'type': 'EXPERIMENTAL', 'label': 'Nerispirdine 200mg', 'description': 'Nerispirdine 200mg once daily for 14 weeks', 'interventionNames': ['Drug: Nerispirdine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for Nerispirdine once daily for 14 weeks', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Nerispirdine', 'type': 'DRUG', 'otherNames': ['HP184'], 'description': 'tablet, oral administration', 'armGroupLabels': ['Nerispirdine 100mg', 'Nerispirdine 200mg', 'Nerispirdine 50mg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'tablet, oral administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'city': 'Laval', 'country': 'Canada', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Lysaker', 'country': 'Norway', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 59.90994, 'lon': 10.63545}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}