Study:
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)
Rationale:
n/a
Purpose:
Teva is developing 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 2
years.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Relapsing Remitting Multiple Sclerosis |
Drug: Glatiramer Acetate (GA) |
Phase 3 |
Verified by
Teva Neuroscience
April, 2007
Sponsored by: Teva Neuroscience
Information provided by: Teva Neuroscience
ClinicalTrials.gov identifier: NCT00337779
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Cleveland Clinic Foundation
Cleveland, Ohio
United States
Judith Zwickel, PhD., Study Chair