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Talampanel for Amyotrophic Lateral Sclerosis (ALS) (ALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00696332
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : October 21, 2011
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

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.

Condition or disease Intervention/treatment Phase
ALS Drug: Talampanel Other: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 559 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : September 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

Arm Intervention/treatment
Experimental: Talampanel 50mg
50mg Talampanel 3 times per day
Drug: Talampanel
capsules Talampanel, 3 times per day, 52 weeks
Other Name: AMPA antagonist

Experimental: Talampanel 25mg
25mg Talampanel 3 times per day
Drug: Talampanel
capsules Talampanel, 3 times per day, 52 weeks
Other Name: AMPA antagonist

Placebo Comparator: Placebo
placebo 3 times per day
Other: placebo
capsules, placebo, 3 times a day, for 52 weeks

Primary Outcome Measures :
  1. Change in ALS Functional Rating Score (ALSFRS-R slope) [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation. [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00696332

Hide Hide 24 study locations
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United States, California
CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center
San Francisco, California, United States, 94115
United States, Kansas
University of Kansas Medical Center - Dept of Neurology
Kansas City, Kansas, United States, 66160
United States, Maryland
Johns Hopkins OPC - Meyer Bldg
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital-Neurology Clinical Trials Unit
Charlestown, Massachusetts, United States, 02129
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Columbia University - Neurology Institute
New York, New York, United States, 10032
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Academic Hospital University of Leuven - ALS dept
Leuven, Belgium, B-3000
Canada, British Columbia
ALS Centre
Vancouver, British Columbia, Canada, V5Z 2G9
Canada, Ontario
London Health Sciences Centre Motor Neuro Diseases Clinic
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Montreal Neurological Institute
Montreal, Quebec, Canada, H3A 2B4
C.H.U. La Timone - Service de Neurologie
Marseille Cedex 5, France, 13385
C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques
Montpellier Cedex 5, France, 34295
Hopital La Pitie Salpetriere - Federation de Neurologie
Paris, France, 75013
Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik
Berlin, Germany, 13353
Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik
Bochum, Germany, 44789
Universitaet Ulm
Ulm, Germany, 89081
Semmelweis University, Department of Neurology
Budapest, Hungary, 1083
Sourasky MC -EMG Unit
Tel Aviv, Israel, 64239
Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone
Lissone (MI), Italy, 20035
Centro Clinico NEMO
Milano, Italy, 20162
Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze
Torino, Italy, 10126
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584 CX
Hospital Carlos III
Madrid, Spain, 28029
Sponsors and Collaborators
Teva Pharmaceutical Industries
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Responsible Party: Teva Pharmaceutical Industries Identifier: NCT00696332    
Other Study ID Numbers: ALS-TAL-201 (ALSTAR)
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: October 21, 2011
Last Verified: October 2011
Keywords provided by Teva Pharmaceutical Industries:
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
alpha-Amino-3-hydroxy-5-methyl-4-isoxazolepropionic Acid
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs