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| ID | Type | Description | Link |
|---|---|---|---|
| ALSTAR |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Talampanel 50mg | Experimental | 50mg Talampanel 3 times per day |
|
| Talampanel 25mg | Experimental | 25mg Talampanel 3 times per day |
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| Placebo | Placebo Comparator | placebo 3 times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talampanel | Drug | capsules Talampanel, 3 times per day, 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in ALS Functional Rating Score (ALSFRS-R slope) | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation. | 52 weeks |
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Subjects with sporadic or familial ALS classified as definite, probable, or laboratory-supported probable ALS according to the revised El Escorial criteria.
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center | San Francisco | California | 94115 | United States | ||
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| Talampanel | Drug | capsules Talampanel, 3 times per day, 52 weeks |
|
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| placebo | Other | capsules, placebo, 3 times a day, for 52 weeks |
|
| University of Kansas Medical Center - Dept of Neurology |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| Johns Hopkins OPC - Meyer Bldg | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital-Neurology Clinical Trials Unit | Charlestown | Massachusetts | 02129 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Columbia University - Neurology Institute | New York | New York | 10032 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Academic Hospital University of Leuven - ALS dept | Leuven | B-3000 | Belgium |
| ALS Centre | Vancouver | British Columbia | V5Z 2G9 | Canada |
| London Health Sciences Centre Motor Neuro Diseases Clinic | London | Ontario | N6A 5A5 | Canada |
| Montreal Neurological Institute | Montreal | Quebec | H3A 2B4 | Canada |
| C.H.U. La Timone - Service de Neurologie | Marseille | 13385 | France |
| C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques | Montpellier | 34295 | France |
| Hopital La Pitie Salpetriere - Federation de Neurologie | Paris | 75013 | France |
| Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik | Berlin | 13353 | Germany |
| Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik | Bochum | 44789 | Germany |
| Universitaet Ulm | Ulm | 89081 | Germany |
| Semmelweis University, Department of Neurology | Budapest | 1083 | Hungary |
| Sourasky MC -EMG Unit | Tel Aviv | 64239 | Israel |
| Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone | Lissone (MI) | 20035 | Italy |
| Centro Clinico NEMO | Milan | 20162 | Italy |
| Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze | Torino | 10126 | Italy |
| Universitair Medisch Centrum Utrecht | Utrecht | 3584 CX | Netherlands |
| Hospital Carlos III | Madrid | 28029 | Spain |
| ID | Term |
|---|---|
| C085266 | talampanel |
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