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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00696332
Other study ID # ALS-TAL-201 (ALSTAR)
Secondary ID ALSTAR
Status Completed
Phase Phase 2
First received June 10, 2008
Last updated October 20, 2011
Start date September 2008
Est. completion date May 2010

Study information

Verified date October 2011
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 559
Est. completion date May 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Subjects with sporadic or familial ALS classified as definite, probable, or laboratory-supported probable ALS according to the revised El Escorial criteria.

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Talampanel
capsules Talampanel, 3 times per day, 52 weeks
Talampanel
capsules Talampanel, 3 times per day, 52 weeks
Other:
placebo
capsules, placebo, 3 times a day, for 52 weeks

Locations

Country Name City State
Belgium Academic Hospital University of Leuven - ALS dept Leuven
Canada London Health Sciences Centre Motor Neuro Diseases Clinic London Ontario
Canada Montreal Neurological Institute Montreal Quebec
Canada ALS Centre Vancouver British Columbia
France C.H.U. La Timone - Service de Neurologie Marseille Cedex 5
France C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques Montpellier Cedex 5
France Hopital La Pitie Salpetriere - Federation de Neurologie Paris
Germany Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik Berlin
Germany Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik Bochum
Germany Universitaet Ulm Ulm
Hungary Semmelweis University, Department of Neurology Budapest
Israel Sourasky MC -EMG Unit Tel Aviv
Italy Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone Lissone (MI)
Italy Centro Clinico NEMO Milano
Italy Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze Torino
Netherlands Universitair Medisch Centrum Utrecht Utrecht
Spain Hospital Carlos III Madrid
United States Johns Hopkins OPC - Meyer Bldg Baltimore Maryland
United States Massachusetts General Hospital-Neurology Clinical Trials Unit Charlestown Massachusetts
United States University of Kansas Medical Center - Dept of Neurology Kansas City Kansas
United States Columbia University - Neurology Institute New York New York
United States Mayo Clinic Rochester Minnesota
United States CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center San Francisco California
United States SUNY Upstate Medical University Syracuse New York

Sponsors (1)

Lead Sponsor Collaborator
Teva Pharmaceutical Industries

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in ALS Functional Rating Score (ALSFRS-R slope) 52 weeks No
Secondary Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation. 52 weeks No
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