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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00326625
Recruitment Status : Completed
First Posted : May 17, 2006
Results First Posted : October 20, 2021
Last Update Posted : October 20, 2021
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc. ( Teva Pharmaceutical Industries, Ltd. )

Brief Summary:
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 or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: 40 mg glatiramer acetate Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Actual Study Start Date : July 27, 2006
Actual Primary Completion Date : June 17, 2008
Actual Study Completion Date : June 17, 2008

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R) [ Time Frame: Baseline, Weeks 4, 8, 12, 17, 22, 26, 31, 36, 40, 44, 48, 52 ]
    The ALSFRS-R is a questionnaire-based scale for monitoring the progression of disability in patients with ALS. It is composed of 12 items, each scored between 0 and 4.The total score, calculated as the sum of these 12 items, ranges from 0 to 48. The higher the score, the less disabled the participant. Timepoints after baseline were included in calculation of slope of change in ALSFRS-R. Slope is derived from the time by treatment interaction term from the Repeated Measures Analysis of Covariance model. Descriptive statistics of the slope are reported.

Secondary Outcome Measures :
  1. Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation [ Time Frame: Baseline up to 52 weeks ]
    Composite endpoint of time to death, tracheostomy, or permanent assisted ventilation analyzed using the Cox's proportional hazards model to compare the risk of death, tracheostomy, or permanent assisted ventilation between treatment groups. The model includes center country, Riluzole© use, site of ALS onset, time from ALS onset, and baseline ALSFRS-R score, baseline slow VC and baseline BMI as covariates. Because less than 50% of participants experienced the event, the median time to event (i.e. the descriptive statistic for the day for which 50% of participants experienced the event) could not be calculated. Hence the days are reported as not available.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00326625

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Teva Benelux
Haarlem, Belgium
Teva Benelux
Leuven, Belgium
Teva France
Paris, France
Teva Germany
Moerfelden-Walldorf, Germany
Teva Germany
Morfelden-Walldorf, Germany
Teva Israel
Tel Aviv, Israel
Teva Italy
Milano, Italy
United Kingdom
Teva UK
Aylesbury, United Kingdom
Sponsors and Collaborators
Teva Pharmaceutical Industries, Ltd.
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Study Chair: Merav Bassan, PhD. Teva Pharmaceuticals Industries LTD
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Responsible Party: Teva Pharmaceutical Industries, Ltd. Identifier: NCT00326625    
Other Study ID Numbers: ALS-GA-201
First Posted: May 17, 2006    Key Record Dates
Results First Posted: October 20, 2021
Last Update Posted: October 20, 2021
Last Verified: September 2021
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Glatiramer Acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents