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

Tracking Information
First Received Date ^ICMJE	June 10, 2008
Last Updated Date	October 20, 2011
Start Date ^ICMJE	September 2008
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 11, 2008)	Change in ALS Functional Rating Score (ALSFRS-R slope) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00696332 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 11, 2008)	Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Talampanel for Amyotrophic Lateral Sclerosis (ALS)
Official Title ^ICMJE	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)
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	ALS
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	559
Completion Date	May 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Subjects with sporadic or familial ALS classified as definite, probable, or laboratory-supported probable ALS according to the revised El Escorial criteria. Inclusion Criteria: 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) Exclusion Criteria: 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.
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Spain

Administrative Information
NCT Number ^ICMJE	NCT00696332
Other Study ID Numbers ^ICMJE	ALS-TAL-201 (ALSTAR), ALSTAR
Has Data Monitoring Committee	Yes
Responsible Party	Teva Pharmaceutical Industries
Study Sponsor ^ICMJE	Teva Pharmaceutical Industries
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Teva Pharmaceutical Industries
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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