Talampanel for Amyotrophic Lateral Sclerosis (ALS)

ALS Clinical Trial

— ALS  

Official title:

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)

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

• ALS
• Amyotrophic Lateral Sclerosis

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