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Talampanel for Amyotrophic Lateral Sclerosis (ALS) | Clinical Trials | Clareo Health

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Talampanel for Amyotrophic Lateral Sclerosis (ALS)

A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of Talampanel in Subjects With Amyotrophic Lateral Sclerosis (ALS)

NCT00696332•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (24)

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

Key Dates

Start Date

September 1, 2008

Primary Completion Date

April 1, 2010

Completion Date

May 1, 2010

Last Updated

October 21, 2011

Enrollment

559

ACTUAL participants

Conditions

ALS

Interventions

Talampanel

DRUG

Talampanel

DRUG

placebo

OTHER

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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: March 29, 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.

View ClinicalTrials.gov Terms and Conditions

Talampanel for Amyotrophic Lateral Sclerosis (ALS)

Inclusion Criteria

Exclusion Criteria

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The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes

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