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

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ClinicalTrials.gov Identifier: NCT00326625
Recruitment Status : Completed
First Posted : May 17, 2006
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )

Study Description
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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

Study Design
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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 31, 2006
Actual Primary Completion Date : June 30, 2008
Actual Study Completion Date : July 31, 2008

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Change from baseline to each visit in ALSFRS-R score


Secondary Outcome Measures :
  1. Time to Death/Tracheostomy/Permanent Assisted Ventilation [ Time Frame: 52 weeks ]

Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00326625


Locations
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Belgium
Teva Benelux
Leuven, Belgium
France
Teva France
Paris, France
Germany
Teva Germany
Morfelden-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, Ltd.
Investigators
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Study Chair: Merav Bassan, PhD. Teva Pharmaceuticals Industries LTD
More Information
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Responsible Party: Teva Pharmaceutical Industries, Ltd.
ClinicalTrials.gov Identifier: NCT00326625    
Other Study ID Numbers: ALS-GA-201
First Posted: May 17, 2006    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
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
(T,G)-A-L
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents