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Talampanel for Amyotrophic Lateral Sclerosis (ALS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00696332
First received: June 10, 2008
Last updated: October 20, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
ALS
 Drug: Talampanel
Other: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change in ALS Functional Rating Score (ALSFRS-R slope) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 559
Study Start Date: September 2008
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696332

  Show 24 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00696332     History of Changes
Other Study ID Numbers: ALS-TAL-201 (ALSTAR), ALSTAR
Study First Received: June 10, 2008
Last Updated: October 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
ALS

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013