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Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00326625
First received: May 16, 2006
Last updated: August 29, 2013
Last verified: August 2013
  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: 40 mg glatiramer acetate
Drug: Placebo
Phase 2

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:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change From Baseline in ALS Functional Rating Score (ALSFRS-R) at Each Visit [ Time Frame: Bseline, Weeks 4, 8, 12, 17, 22, 26, 31, 36, 40, 44, 48, 52 ] [ Designated as safety issue: No ]
    Change from baseline to each visit in ALSFRS-R score


Secondary Outcome Measures:
  • Time to Death/Tracheostomy/Permanent Assisted Ventilation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 366
Study Start Date: July 2006
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 40 mg glatiramer acetate (GA)
Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day.
Drug: 40 mg glatiramer acetate
parenteral drug
Placebo Comparator: Placebo
Pre-filled syringe of matching placebo, administered subcutaneously once a day.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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. Stable dose of riluzole for at least 8 weeks prior to screening.
  6. Age - 18-70 (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. Subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).
  5. Additional criteria per protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00326625     History of Changes
Other Study ID Numbers: ALS-GA-201
Study First Received: May 16, 2006
Last Updated: August 29, 2013
Health Authority: United States: Food and Drug Administration
France: Ministry of Health

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Sclerosis
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014