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COMPLETEDPhase 2NCT00696332

Talampanel for Amyotrophic Lateral Sclerosis (ALS)

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.

Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.•7 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

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

Exclusion Criteria

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 21, 2011Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment559

Start dateSep 2008

Last updatedOct 21, 2011

Condition

Locations shown

CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center

San Francisco, California

University of Kansas Medical Center - Dept of Neurology

Kansas City, Kansas

Johns Hopkins OPC - Meyer Bldg

Baltimore, Maryland

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2011Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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