A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose
Relapse-Remitting Multiple Sclerosis

About this trial
This is an interventional treatment trial for Relapse-Remitting Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria: Clinically definite MS with disease duration (from onset) of at least 6 months. Subjects must have had at least 1 documented relapse within the last year prior to study entry. Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan. Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit. Subjects must not have taken corticosteroids (IV, IM and/or PO) between the screening and baseline visits. Subjects may be male or female. Women of child- bearing potential must practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, or double-barrier method (condom or IUD with spermicide). Subjects must be between the ages of 18 and 50 years inclusive. Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5 inclusive. Subjects must be willing and able to give written informed consent prior to entering the study. Exclusion Criteria: Previous use of glatiramer acetate (oral or injectable). Previous use of cladribine. Previous use of immunosuppressive agents in the last 6 months. Use of experimental or investigational drugs, including I.V. immunoglobulin, and/or participation in an investigational drug study within 6 months prior to study entry. Use of interferon agents within 60 days prior to the screening visit. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry. Previous total body irradiation or total lymphoid irradiation (TLI). Pregnancy or breast feeding. Patients who experience a relapse between the screening (month -1) and baseline (month 0) visits. Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse. A known history of sensitivity to mannitol. A known sensitivity to gadolinium. Inability to successfully undergo MRI scanning.
Sites / Locations
- Center for Neurologic Study
- North County Neurology Associates
- The MS Center of Atlanta
- Consultants in Neurology, Ltd
- Indiana University School of Medicine
- The Maryland Center for M.S.
- Michigan Institute of Neurological Disorders
- The Minneapolis Clinic of Neurology, LTD
- University of Minnesota
- St. John's Mercy Medical Center
- Clinical & Magnetic Resonance Research Ctr.
- MSSM - Corinne Goldsmith Dickinson Center for MS
- University of Rochester
- Cleveland Clinic Foundation
- Geisinger Medical Center
- Allegheny Neurological Associates
- University of Tennessee
- VAMC
- MS Hub Medical Group
- Neurology & Neurosurgery
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
glatiramer acetate 20 mg
glatiramer acetate 40 mg
glatiramer acetate 20 mg
glatiramer acetate 40 mg