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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
559
capsules Talampanel, 3 times per day, 52 weeks
capsules Talampanel, 3 times per day, 52 weeks
capsules, placebo, 3 times a day, for 52 weeks
Change in ALS Functional Rating Score (ALSFRS-R slope)
Time frame: 52 weeks
Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation.
Time frame: 52 weeks
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CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center
San Francisco, California, United States
University of Kansas Medical Center - Dept of Neurology
Kansas City, Kansas, United States
Johns Hopkins OPC - Meyer Bldg
Baltimore, Maryland, United States
Massachusetts General Hospital-Neurology Clinical Trials Unit
Charlestown, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Columbia University - Neurology Institute
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Academic Hospital University of Leuven - ALS dept
Leuven, Belgium
ALS Centre
Vancouver, British Columbia, Canada
London Health Sciences Centre Motor Neuro Diseases Clinic
London, Ontario, Canada
...and 14 more locations