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
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Sponsor:
Teva Pharmaceutical Industries, Ltd.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )
Tracking Information | ||||
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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 |
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
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Original Primary Outcome Measures ICMJE |
Change in ALS Functional Rating Score (ALSFRS-R slope) | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Time to Death/Tracheostomy/Permanent Assisted Ventilation [ Time Frame: 52 weeks ] | |||
Original Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE | Amyotrophic Lateral Sclerosis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
366 | |||
Original Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |