Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS) - Full Text View

Sponsor:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00326625

Purpose

Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties, which are believed to be of therapeutic value in ALS. The study treatment duration is 1 year (52 weeks).

Condition	Intervention	Phase
Amyotrophic Lateral Sclerosis	Drug: Parenteral Drug / 40 mg Glatiramer Acetate	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of 40 mg Glatiramer Acetate Injection 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

Drug Information available for: Copolymer 1

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:

Change in muscle strength (Manual Muscle Test) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Change in pulmonary function (Slow Vital Capacity) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Change in quality of life (SF-36®) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	300
Study Start Date:	June 2006
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Pre-filled syringe, 40 mg, administered subcutaneous, once a day

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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.
Stable dose of riluzole for at least 8 weeks prior to screening.
Age - 18-70 (inclusive)

Exclusion Criteria:

The use of invasive or non-invasive ventilation.
Subject having undergone gastrostomy.
Subject with any clinically significant or unstable medical condition.
Subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326625

Locations

Belgium
Teva Benelux
Haarlem, Belgium
France
Teva France
Paris, France
Germany
Teva Germany
Moerfelden-Walldorf, Germany
Israel
Teva Israel
Tel Aviv, Israel
Italy
Teva Italy
Milano, Italy
United Kingdom
Teva UK
Aylesbury, United Kingdom

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Chair:

Merav Bassan, PhD.

Teva Pharmaceuticals Industries LTD

More Information

No publications provided

Responsible Party:	Siyu Liu, Vice President, North American Innovative Research and Development and Head of Global Clinical Operations, Teva Neuroscience
ClinicalTrials.gov Identifier:	NCT00326625 History of Changes
Other Study ID Numbers:	ALS-GA-201
Study First Received:	May 16, 2006
Last Updated:	June 7, 2010
Health Authority:	United States: Food and Drug Administration; France: Ministry of Health

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
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 09, 2012