Talampanel for Amyotrophic Lateral Sclerosis (ALS) - Full Text View

Sponsored by:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00696332

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 Drug: placebo	Phase II

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

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 ]

Estimated Enrollment:	540
Study Start Date:	September 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 50mg Talampanel 3 times per day	Drug: Talampanel capsules Talampanel, 3 times per day, 52 weeks
2: Experimental 25mg Talampanel 3 times per day	Drug: Talampanel capsules Talampanel, 3 times per day, 52 weeks
3: Placebo Comparator placebo 3 times per day	Drug: 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:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696332

Contacts

Contact: Merav Bassan, Ph.D.

(972)-9-863-1972

merav.bassan@teva.co.il

Show 24 Study Locations

Sponsors and Collaborators

Teva Pharmaceutical Industries

More Information

Responsible Party:	Teva Neuroscience ( Siyu Liu, Vice President, North American IR&D and Head of Global Clinical Operations )
Study ID Numbers:	ALS-TAL-201 (ALSTAR), ALSTAR
Study First Received:	June 10, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00696332
Health Authority:	United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:

ALS

Study placed in the following topic categories:

Amyotrophic lateral sclerosis
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Central Nervous System Diseases
Lou Gehrig's disease

Sclerosis
Degenerative motor system disease
Neurodegenerative Diseases
Motor neuron disease
Motor Neuron Disease

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009