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

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries
• Treatments: (T,G)-A-L; Glatiramer Acetate

Criteria

Inclusion Criteria:

1. Clinically definite MS with disease duration (from onset) of at least 6 months.

2. Subjects must have had at least 1 documented relapse within the last year prior to study entry.

3. Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan.

4. Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit.

5. Subjects must not have taken corticosteroids (IV, IM and/or PO) between the screening and baseline visits.

6. 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).

7. Subjects must be between the ages of 18 and 50 years inclusive.

8. Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5 inclusive.

9. Subjects must be willing and able to give written informed consent prior to entering the study.

Exclusion Criteria:

1. Previous use of glatiramer acetate (oral or injectable).

2. Previous use of cladribine.

3. Previous use of immunosuppressive agents in the last 6 months.

4. 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.

5. Use of interferon agents within 60 days prior to the screening visit.

6. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry.

7. Previous total body irradiation or total lymphoid irradiation (TLI).

8. Pregnancy or breast feeding.

9. Patients who experience a relapse between the screening (month -1) and baseline (month 0) visits.

10. Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse.

11. A known history of sensitivity to mannitol.

12. A known sensitivity to gadolinium.

13. Inability to successfully undergo MRI scanning.