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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.
 
ClinicalTrials.gov Identifier: NCT00696332
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : October 21, 2011
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Study Description
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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

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00696332


Locations
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Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
More Information
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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT00696332    
Other Study ID Numbers: ALS-TAL-201 (ALSTAR)
ALSTAR
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: October 21, 2011
Last Verified: October 2011
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.:
ALS
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