A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo

• Status: Completed
• Trial end date: 2017-05-12

Summary

The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in subjects with RRMS, as measured by the number of confirmed relapses during the 12 month placebo controlled period. The study has two periods:

• Placebo Controlled Period: 12 months of 40 mg administered three times a week by subcutaneous injection or matching placebo.

• Open Label Extension Period: All subjects will continue treatment with GA 40 mg administered three times a week, until this dose strength is commercially available for the treatment of relapsing remitting multiple sclerosis (RRMS) patients or until the development of this GA dose regimen is stopped by the Sponsor

• Phase: Phase 3

Details

• Lead Sponsor: Teva Pharmaceutical Industries; Teva Pharmaceutical Industries, Ltd.
• Treatments: (T,G)-A-L; Glatiramer Acetate