Talampanel for Amyotrophic Lateral Sclerosis (ALS)

Completed · Phase 2 · Has a placebo group

Conditions studied: ALS

In brief

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.

Key facts

Study ID

NCT00696332

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

559

Starts

2008-09-01

Expected to finish

2010-05-01

Last updated by the study team

2011-10-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria.
• Subject has experienced his/her first ALS symptoms within 3 years prior to the screening visit.
• Slow VC test equal to or greater than 70% of the predicted value.
• The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points.
• Subjects taking riluzole must be on a stable dose for at least 8 weeks prior to screening visit.
• Ages 18-80 (inclusive)

You may not qualify if…

• The use of invasive or non-invasive ventilation.
• Subject having undergone gastrostomy.
• Subject with any clinically significant or unstable medical condition.
• Subject participating in any other investigational drug trial or using investigational drug (within 12 weeks prior to screening and thereafter).
• Females who are pregnant or nursing.

Where it is running

• 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
• Montreal Neurological Institute — Montreal, Quebec, Canada
• C.H.U. La Timone - Service de Neurologie — Marseille, France
• C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques — Montpellier, France
• Hopital La Pitie Salpetriere - Federation de Neurologie — Paris, France
• Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik — Berlin, Germany
• Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik — Bochum, Germany
• Universitaet Ulm — Ulm, Germany
• Semmelweis University, Department of Neurology — Budapest, Hungary
• Sourasky MC -EMG Unit — Tel Aviv, Israel
• Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone — Lissone (MI), Italy
• Centro Clinico NEMO — Milan, Italy
• Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze — Torino, Italy
• Universitair Medisch Centrum Utrecht — Utrecht, Netherlands
• Hospital Carlos III — Madrid, Spain

Full record on ClinicalTrials.gov

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