Conditions: Amyotrophic Lateral Sclerosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 366
Healthy volunteers: no

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:

Arms:
arm 1: Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day. arm 2: Pre-filled syringe of matching placebo, administered subcutaneously once a day.

Interventions: intervention 1: 40 mg glatiramer acetate intervention 2: Placebo
Intervention descriptions: intervention 1: parenteral drug intervention 2: None

Protocol document: