A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose
NCT ID: NCT00202982
Last Updated: 2010-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2003-08-31
2005-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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glatiramer acetate 20 mg
glatiramer acetate 20 mg
glatiramer acetate 20 mg
glatiramer acetate 20 mg
glatiramer acetate 40 mg
glatiramer acetate 40 mg
glatiramer acetate 40 mg
glatiramer acetate 40 mg
Interventions
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glatiramer acetate 20 mg
glatiramer acetate 20 mg
glatiramer acetate 40 mg
glatiramer acetate 40 mg
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
50 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Teva Neuroscience
Principal Investigators
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Jeffery Cohen, MD
Role: STUDY_CHAIR
The Cleveland Clinic
Locations
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Center for Neurologic Study
La Jolla, California, United States
North County Neurology Associates
Oceanside, California, United States
The MS Center of Atlanta
Atlanta, Georgia, United States
Consultants in Neurology, Ltd
Northbrook, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
The Maryland Center for M.S.
Baltimore, Maryland, United States
Michigan Institute of Neurological Disorders
Farmington Hills, Michigan, United States
The Minneapolis Clinic of Neurology, LTD
Golden Valley, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
Clinical & Magnetic Resonance Research Ctr.
Albuquerque, New Mexico, United States
MSSM - Corinne Goldsmith Dickinson Center for MS
New York, New York, United States
University of Rochester
Rochester, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Allegheny Neurological Associates
Pittsburgh, Pennsylvania, United States
University of Tennessee
Memphis, Tennessee, United States
VAMC
Salt Lake City, Utah, United States
MS Hub Medical Group
Seattle, Washington, United States
Neurology & Neurosurgery
Tacoma, Washington, United States
Countries
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Other Identifiers
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9006
Identifier Type: -
Identifier Source: org_study_id
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