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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. )

Tracking Information
First Submitted Date  ICMJE May 16, 2006
First Posted Date  ICMJE May 17, 2006
Last Update Posted Date February 20, 2018
Actual Study Start Date  ICMJE July 31, 2006
Actual Primary Completion Date June 30, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2013)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2006)		 Change in ALS Functional Rating Score (ALSFRS-R slope)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2013)		 Time to Death/Tracheostomy/Permanent Assisted Ventilation [ Time Frame: 52 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2006)
  • Change in muscle strength (Manual Muscle Test)
  • Change in pulmonary function (Slow Vital Capacity)
  • Change in quality of life (SF-36®)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • Drug: 40 mg glatiramer acetate
    parenteral drug
  • Drug: Placebo
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2013)		 366
Original Enrollment  ICMJE
 (submitted: May 16, 2006)		 300
Actual Study Completion Date  ICMJE July 31, 2008
Actual Primary Completion Date June 30, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Israel,   Italy,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00326625
Other Study ID Numbers  ICMJE ALS-GA-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )
Study Sponsor  ICMJE Teva Pharmaceutical Industries, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Merav Bassan, PhD. Teva Pharmaceuticals Industries LTD
PRS Account Teva Pharmaceutical Industries
Verification Date February 2018

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