drugset / Trial / NCT00337779

Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).

NCT00337779

Phase 3 Completed 1155 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

Teva is developing a 40 mg/ml GA Injection, administered once daily under the skin, for the treatment of R-R MS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of R-R MS. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties. The study treatment duration is 12 months.

Timeline

Start
2006-08
Primary completion
2008-10
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glatiramer Acetate Small molecule 20 mg Subcutaneous
Comparator Glatiramer Acetate Small molecule 40 mg Subcutaneous