Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)
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).
Timeline
- Start
- 2006-07-27
- Primary completion
- 2008-06-17
- Completion
- 2008-06-17
Outcome
Missed primary endpoint
registry analysis (superiority test); Glatiramer Acetate 40mg vs Placebo; p = 0.4807; Slope difference -0.06 (95% CI -0.22 to 0.10); ANCOVA NCT00326625 ↗
release “Results show that GA 40mg was safe and well-tolerated in ALS patients; however, the study's primary and secondary endpoints were not met.” tevapharm.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glatiramer Acetate | Small molecule | 40 mg | Subcutaneous |