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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

May 16, 2006
August 29, 2013
July 2006
June 2008   (final data collection date for primary outcome measure)
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
Change in ALS Functional Rating Score (ALSFRS-R slope)
Complete list of historical versions of study NCT00326625 on ClinicalTrials.gov Archive Site
Time to Death/Tracheostomy/Permanent Assisted Ventilation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change in muscle strength (Manual Muscle Test)
  • Change in pulmonary function (Slow Vital Capacity)
  • Change in quality of life (SF-36®)
Not Provided
Not Provided
 
Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)
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)

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis
  • Drug: 40 mg glatiramer acetate
    parenteral drug
  • Drug: Placebo
  • Experimental: 40 mg glatiramer acetate (GA)
    Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day.
    Intervention: Drug: 40 mg glatiramer acetate
  • Placebo Comparator: Placebo
    Pre-filled syringe of matching placebo, administered subcutaneously once a day.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
366
July 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Israel,   Italy,   United Kingdom
 
NCT00326625
ALS-GA-201
Not Provided
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Study Chair: Merav Bassan, PhD. Teva Pharmaceuticals Industries LTD
Teva Pharmaceutical Industries
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP