Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT00696332
Status:
COMPLETED
Last Update Posted:
2011-10-21
First Post:
2008-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Talampanel for Amyotrophic Lateral Sclerosis (ALS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C085266', 'term': 'talampanel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 559}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'dispFirstSubmitDate': '2011-08-16', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-20', 'studyFirstSubmitDate': '2008-06-10', 'dispFirstSubmitQcDate': '2011-08-16', 'studyFirstSubmitQcDate': '2008-06-11', 'dispFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ALS Functional Rating Score (ALSFRS-R slope)', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation.', 'timeFrame': '52 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ALS'], 'conditions': ['ALS']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy, tolerability and safety of oral administration of talampanel compared to a placebo in subjects with ALS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Subjects with sporadic or familial ALS classified as definite, probable, or laboratory-supported probable ALS according to the revised El Escorial criteria.\n\nInclusion Criteria:\n\n1. Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria.\n2. Subject has experienced his/her first ALS symptoms within 3 years prior to the screening visit.\n3. Slow VC test equal to or greater than 70% of the predicted value.\n4. The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points.\n5. Subjects taking riluzole must be on a stable dose for at least 8 weeks prior to screening visit.\n6. Ages 18-80 (inclusive)\n\nExclusion Criteria:\n\n1. The use of invasive or non-invasive ventilation.\n2. Subject having undergone gastrostomy.\n3. Subject with any clinically significant or unstable medical condition.\n4. Subject participating in any other investigational drug trial or using investigational drug (within 12 weeks prior to screening and thereafter).\n5. Females who are pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT00696332', 'acronym': 'ALS', 'briefTitle': 'Talampanel for Amyotrophic Lateral Sclerosis (ALS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of Talampanel in Subjects With Amyotrophic Lateral Sclerosis (ALS)', 'orgStudyIdInfo': {'id': 'ALS-TAL-201 (ALSTAR)'}, 'secondaryIdInfos': [{'id': 'ALSTAR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Talampanel 50mg', 'description': '50mg Talampanel 3 times per day', 'interventionNames': ['Drug: Talampanel']}, {'type': 'EXPERIMENTAL', 'label': 'Talampanel 25mg', 'description': '25mg Talampanel 3 times per day', 'interventionNames': ['Drug: Talampanel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo 3 times per day', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Talampanel', 'type': 'DRUG', 'otherNames': ['AMPA antagonist'], 'description': 'capsules Talampanel, 3 times per day, 52 weeks', 'armGroupLabels': ['Talampanel 50mg']}, {'name': 'Talampanel', 'type': 'DRUG', 'otherNames': ['AMPA antagonist'], 'description': 'capsules Talampanel, 3 times per day, 52 weeks', 'armGroupLabels': ['Talampanel 25mg']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'capsules, placebo, 3 times a day, for 52 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center - Dept of Neurology', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins OPC - Meyer Bldg', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02129', 'city': 'Charlestown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital-Neurology Clinical Trials Unit', 'geoPoint': {'lat': 42.37787, 'lon': -71.062}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University - Neurology Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Academic Hospital University of Leuven - ALS dept', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'V5Z 2G9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'ALS Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre Motor Neuro Diseases Clinic', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'H3A 2B4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Neurological Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'C.H.U. La Timone - Service de Neurologie', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital La Pitie Salpetriere - Federation de Neurologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44789', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitaet Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '1083', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University, Department of Neurology', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky MC -EMG Unit', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '20035', 'city': 'Lissone (MI)', 'country': 'Italy', 'facility': 'Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone', 'geoPoint': {'lat': 45.61236, 'lon': 9.23985}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'Centro Clinico NEMO', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '28029', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Carlos III', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}