Talampanel for Amyotrophic Lateral Sclerosis (ALS)

Phase 2

Completed

• Conditions: ALS
• Interventions: Drug: Talampanel; Other: placebo

• Registration Number: NCT00696332
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-06-11
• Study First Posted: 2008-06-12
• Study Start: 2008-09
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Disposition First Submitted: 2011-08-16
• Disposition First Submitted QC: 2011-08-16
• Disposition First Posted: 2011-08-23
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-20
• Last Update Posted: 2011-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 559

Inclusion 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Talampanel 50mg	Talampanel	50mg Talampanel 3 times per day
Talampanel 25mg	Talampanel	25mg Talampanel 3 times per day
Placebo	placebo	placebo 3 times per day

Primary Outcome Measures

Name	Time	Method
Change in ALS Functional Rating Score (ALSFRS-R slope)	52 weeks

Secondary Outcome Measures

Name	Time	Method
Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation.	52 weeks

Trial Locations

Locations (24)

Academic Hospital University of Leuven - ALS dept; 🇧🇪 Leuven, Belgium

C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques; 🇫🇷 Montpellier Cedex 5, France

Montreal Neurological Institute; 🇨🇦 Montreal, Quebec, Canada

Columbia University - Neurology Institute; 🇺🇸 New York, New York, United States

Hopital La Pitie Salpetriere - Federation de Neurologie; 🇫🇷 Paris, France

Semmelweis University, Department of Neurology; 🇭🇺 Budapest, Hungary

Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone; 🇮🇹 Lissone (MI), Italy

Massachusetts General Hospital-Neurology Clinical Trials Unit; 🇺🇸 Charlestown, Massachusetts, United States

London Health Sciences Centre Motor Neuro Diseases Clinic; 🇨🇦 London, Ontario, Canada

C.H.U. La Timone - Service de Neurologie; 🇫🇷 Marseille Cedex 5, France

CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center; 🇺🇸 San Francisco, California, United States

Johns Hopkins OPC - Meyer Bldg; 🇺🇸 Baltimore, Maryland, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States

University of Kansas Medical Center - Dept of Neurology; 🇺🇸 Kansas City, Kansas, United States

Centro Clinico NEMO; 🇮🇹 Milano, Italy

Universitaet Ulm; 🇩🇪 Ulm, Germany

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands

Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze; 🇮🇹 Torino, Italy

Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik; 🇩🇪 Berlin, Germany

Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik; 🇩🇪 Bochum, Germany

Sourasky MC -EMG Unit; 🇮🇱 Tel Aviv, Israel

Hospital Carlos III; 🇪🇸 Madrid, Spain

ALS Centre; 🇨🇦 Vancouver, British Columbia, Canada