Status:
COMPLETED
A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Relapse-Remitting Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00202982
Start Date
August 1 2003
End Date
September 1 2005
Last Update
January 14 2010
Active Locations (20)
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1
Center for Neurologic Study
La Jolla, California, United States, 92037
2
North County Neurology Associates
Oceanside, California, United States, 92056
3
The MS Center of Atlanta
Atlanta, Georgia, United States
4
Consultants in Neurology, Ltd
Northbrook, Illinois, United States, 60062