Status:
COMPLETED
Talampanel for Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
ALS
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Subjects with sporadic or familial ALS classified as definite, probable, or laboratory-supported probable ALS according to the revised El Escorial criteria.
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
559 Patients enrolled
Trial Details
Trial ID
NCT00696332
Start Date
September 1 2008
End Date
May 1 2010
Last Update
October 21 2011
Active Locations (24)
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1
CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center
San Francisco, California, United States, 94115
2
University of Kansas Medical Center - Dept of Neurology
Kansas City, Kansas, United States, 66160
3
Johns Hopkins OPC - Meyer Bldg
Baltimore, Maryland, United States, 21287
4
Massachusetts General Hospital-Neurology Clinical Trials Unit
Charlestown, Massachusetts, United States, 02129