NCT00337779

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

A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind Study to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to That of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects With Relapsing Remitting (R-R) Multiple Sclerosis (MS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,155 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Glatiramer Acetate (GA) 40 mg	Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months
DRUG	glatiramer acetate 20 mg	Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2006-06-16
• Last updated: 2011-10-10
• Results posted: 2010-05-14