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

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:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

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:

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

Hide Study Locations

Locations

United States, California
CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center
San Francisco, California, United States, 94115
United States, Kansas
University of Kansas Medical Center - Dept of Neurology
Kansas City, Kansas, United States, 66160
United States, Maryland
Johns Hopkins OPC - Meyer Bldg
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital-Neurology Clinical Trials Unit
Charlestown, Massachusetts, United States, 02129
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Columbia University - Neurology Institute
New York, New York, United States, 10032
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Belgium
Academic Hospital University of Leuven - ALS dept
Leuven, Belgium, B-3000
Canada, British Columbia
ALS Centre
Vancouver, British Columbia, Canada, V5Z 2G9
Canada, Ontario
London Health Sciences Centre Motor Neuro Diseases Clinic
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Montreal Neurological Institute
Montreal, Quebec, Canada, H3A 2B4
France
C.H.U. La Timone - Service de Neurologie
Marseille Cedex 5, France, 13385
C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques
Montpellier Cedex 5, France, 34295
Hopital La Pitie Salpetriere - Federation de Neurologie
Paris, France, 75013
Germany
Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik
Berlin, Germany, 13353
Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik
Bochum, Germany, 44789
Universitaet Ulm
Ulm, Germany, 89081
Hungary
Semmelweis University, Department of Neurology
Budapest, Hungary, 1083
Israel
Sourasky MC -EMG Unit
Tel Aviv, Israel, 64239
Italy
Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone
Lissone (MI), Italy, 20035
Centro Clinico NEMO
Milano, Italy, 20162
Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze
Torino, Italy, 10126
Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584 CX
Spain
Hospital Carlos III
Madrid, Spain, 28029

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 21, 2013