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Talampanel for Amyotrophic Lateral Sclerosis (ALS) (ALS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00696332
First Posted: June 12, 2008
Last Update Posted: October 21, 2011
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.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
June 10, 2008
June 12, 2008
October 21, 2011
September 2008
April 2010   (Final data collection date for primary outcome measure)
Change in ALS Functional Rating Score (ALSFRS-R slope) [ Time Frame: 52 weeks ]
Same as current
Complete list of historical versions of study NCT00696332 on ClinicalTrials.gov Archive Site
Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation. [ Time Frame: 52 weeks ]
Same as current
Not Provided
Not Provided
 
Talampanel for Amyotrophic Lateral Sclerosis (ALS)
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)
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
ALS
  • Drug: Talampanel
    capsules Talampanel, 3 times per day, 52 weeks
    Other Name: AMPA antagonist
  • Other: placebo
    capsules, placebo, 3 times a day, for 52 weeks
  • Experimental: Talampanel 50mg
    50mg Talampanel 3 times per day
    Intervention: Drug: Talampanel
  • Experimental: Talampanel 25mg
    25mg Talampanel 3 times per day
    Intervention: Drug: Talampanel
  • Placebo Comparator: Placebo
    placebo 3 times per day
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
559
May 2010
April 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Spain,   United States
 
 
NCT00696332
ALS-TAL-201 (ALSTAR)
ALSTAR
Yes
Not Provided
Not Provided
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Not Provided
Teva Pharmaceutical Industries
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP