Conditions: Relapsing-Remitting Multiple Sclerosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 178
Healthy volunteers: no

Brief summary:
This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).

Detailed description:
Approximately 1400 participants were planned for this study, however only 178 were enrolled prior to early termination.

Arms:
arm 1: Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily. arm 2: Placebo solution in prefilled syringe for subcutaneous injection once daily.

Interventions: intervention 1: Glatiramer Acetate intervention 2: Placebo
Intervention descriptions: intervention 1: Glatiramer acetate 20mg in 0.5ml for subcutaneous injection in a pre-filled syringe (PFS) is administered daily. Each PFS also contains 20mg mannitol dissolved in water for injection. intervention 2: Matching placebo injection; 20 mg mannitol dissolved in 0.5 mL water for subcutaneous injection in a PFS is administered daily.

Protocol document: