Talampanel for Amyotrophic Lateral Sclerosis (ALS)

NCT00696332 | Completed Phase 2 DMC

• 2 other identifiers: ALS-TAL-201 (ALSTAR)ALSTAR
• Study Type: interventional
• Target: 559
• Locations: 10 countries
• Sites: 24

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.

Conditions

ALS

Keywords

ALS

Outcome Measures

Primary Outcomes (1)

• Change in ALS Functional Rating Score (ALSFRS-R slope)

  52 weeks

Secondary Outcomes (1)

• Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation.

  52 weeks

Study Arms (3)

Talampanel 50mg

EXPERIMENTAL

50mg Talampanel 3 times per day

Drug: Talampanel

Talampanel 25mg

EXPERIMENTAL

25mg Talampanel 3 times per day

Drug: Talampanel

Placebo

PLACEBO COMPARATOR

placebo 3 times per day

Other: placebo

Interventions

Talampanel DRUG

capsules Talampanel, 3 times per day, 52 weeks

Also known as: AMPA antagonist

Talampanel 50mg

placebo OTHER

capsules, placebo, 3 times a day, for 52 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (24)

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

San Francisco, California, 94115, United States

Location

University of Kansas Medical Center - Dept of Neurology

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins OPC - Meyer Bldg

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital-Neurology Clinical Trials Unit

Charlestown, Massachusetts, 02129, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia University - Neurology Institute

New York, New York, 10032, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Academic Hospital University of Leuven - ALS dept

Leuven, B-3000, Belgium

Location

ALS Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

London Health Sciences Centre Motor Neuro Diseases Clinic

London, Ontario, N6A 5A5, Canada

Location

Montreal Neurological Institute

Montreal, Quebec, H3A 2B4, Canada

Location

C.H.U. La Timone - Service de Neurologie

Marseille, 13385, France

Location

C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques

Montpellier, 34295, France

Location

Hopital La Pitie Salpetriere - Federation de Neurologie

Paris, 75013, France

Location

Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik

Berlin, 13353, Germany

Location

Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik

Bochum, 44789, Germany

Location

Universitaet Ulm

Ulm, 89081, Germany

Location

Semmelweis University, Department of Neurology

Budapest, 1083, Hungary

Location

Sourasky MC -EMG Unit

Tel Aviv, 64239, Israel

Location

Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone

Lissone (MI), 20035, Italy

Location

Centro Clinico NEMO

Milan, 20162, Italy

Location

Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze

Torino, 10126, Italy

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Location

Hospital Carlos III

Madrid, 28029, Spain

Location

MeSH Terms

Interventions

talampanel

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 12, 2008
• Study Start: September 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 21, 2011

Record last verified: 2011-10

Locations

US (7); BE (1); DE (3); IL (1); IT (3); NL (1); FR (3); CA (3); HU (1); ES (1)