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

Study Overview
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Brief Summary
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This is a study to test if a new higher dose of Copaxone is more effective in treating relapsing-remitting multiple sclerosis than the currently available 20 mg dose.

Official Title
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A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy, Tolerability and Safety of 40 mg of Copaxone in the Treatment of Relapsing-Remitting Multiple Sclerosis Patients

Conditions
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Relapse-Remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: glatiramer acetate 20 mg
* Drug: glatiramer acetate 40 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: glatiramer acetate 20 mg<br>glatiramer acetate 20 mg | Drug: glatiramer acetate 20 mg<br>* glatiramer acetate 20 mg<br>|
| Active Comparator: glatiramer acetate 40 mg<br>glatiramer acetate 40 mg | Drug: glatiramer acetate 40 mg<br>* glatiramer acetate 40 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total number of T1 Gd-enhancing lesions in T1-weighted images, as measured at months 7, 8 and 9 |  |  |