At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Glatiramer Acetate (GA) 40 mg and glatiramer acetate 20 mg for Relapsing Remitting Multiple Sclerosis. Completed, enrolled 1,155 participants.
Detailed 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.
Study Details
Timeline
Interventions
Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months
Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months