drugset / Trial / NCT00326625

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

NCT00326625

Phase 2 Completed 366 enrolled Teva Pharmaceutical Industries, Ltd.
RandomizedParallel-groupDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Glatiramer Acetate Small molecule 40 mg Subcutaneous