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Sponsored by: |
Teva Pharmaceutical Industries |
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Information provided by: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00202982 |
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.
Condition | Intervention | Phase |
---|---|---|
Relapse-Remitting Multiple Sclerosis |
Drug: glatiramer acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
North County Neurology Associates | |
Oceanside, California, United States, 92056 | |
Center for Neurologic Study | |
La Jolla, California, United States, 92037 | |
United States, Georgia | |
The MS Center of Atlanta | |
Atlanta, Georgia, United States | |
United States, Illinois | |
Consultants in Neurology, Ltd | |
Northbrook, Illinois, United States, 60062 | |
United States, Indiana | |
Indiana University School of Medicine | |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
The Maryland Center for M.S. | |
Baltimore, Maryland, United States | |
United States, Michigan | |
Michigan Institute of Neurological Disorders | |
Farmington Hills, Michigan, United States, 48334 | |
United States, Minnesota | |
The Minneapolis Clinic of Neurology, LTD | |
Golden Valley, Minnesota, United States, 55422 | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Missouri | |
St. John's Mercy Medical Center | |
St. Louis, Missouri, United States, 63141 | |
United States, New Mexico | |
Clinical & Magnetic Resonance Research Ctr. | |
Albuquerque, New Mexico, United States, 87131 | |
United States, New York | |
University of Rochester | |
Rochester, New York, United States, 14642 | |
MSSM - Corinne Goldsmith Dickinson Center for MS | |
New York, New York, United States, 10029 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Allegheny Neurological Associates | |
Pittsburgh, Pennsylvania, United States, 15212 | |
Geisinger Medical Center | |
Danville, Pennsylvania, United States, 17822 | |
United States, Tennessee | |
University of Tennessee | |
Memphis, Tennessee, United States, 38163 | |
United States, Utah | |
VAMC | |
Salt Lake City, Utah, United States, 84148 | |
United States, Washington | |
MS Hub Medical Group | |
Seattle, Washington, United States, 98101 | |
Neurology & Neurosurgery | |
Tacoma, Washington, United States, 98405 |
Study Chair: | Jeffery Cohen, MD | Unaffiliated |
Responsible Party: | Teva Neuroscience ( J. Michael Nicholas, Ph.D. ) |
Study ID Numbers: | 9006 |
Study First Received: | September 12, 2005 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00202982 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Copolymer 1 Autoimmune Diseases Multiple Sclerosis Immunologic Factors Demyelinating Diseases Adjuvants, Immunologic |
Demyelinating Autoimmune Diseases, CNS Sclerosis Immunosuppressive Agents Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
Autoimmune Diseases Demyelinating Diseases Immune System Diseases Immunologic Factors Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Sclerosis |
Multiple Sclerosis, Relapsing-Remitting Immunosuppressive Agents Pharmacologic Actions Copolymer 1 Multiple Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |