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Sponsored by: |
Teva Pharmaceutical Industries |
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Information provided by: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00203021 |
Patients have scheduled visits every 3 months to assess Copaxone safety and their Multiple Sclerosis status.
Condition | Intervention | Phase |
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Multiple Sclerosis |
Drug: glatiramer acetate Drug: mannitol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open Label Study to Evaluate the Safety of Copaxone® and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated With Copaxone® |
Enrollment: | 208 |
Study Start Date: | July 1994 |
Estimated Study Completion Date: | July 2012 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
open label treatment
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Drug: glatiramer acetate
20mg, subcutaneous injection once daily, pre-filled syringe. Glatiramer acetate and mannitol contained in same pre-filled syringe.
Drug: mannitol
40mg, subcutaneous injection once daily, pre-filled syringe. Glatiramer acetate and mannitol contained in same pre-filled syringe.
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Open label study to evaluate the safety of Copaxone and its effect on the neurologic course of patients with relapsing-remitting MS. Copaxone® Injection, a clear, colorless to slightly yellow, sterile, non-pyrogenic solution for subcutaneous injection is be self-injected daily by patients.
After all eligibility criteria for each patient was met treatment commenced for that patient. Patients will be evaluated every three months for safety and every six months for change in neurological status. Neurological examinations include Functional system evaluation, Kurtzke, Expanded Disability Status score, Ambulation Index.
The eleven University Hospital centers in the United States which participated in the Double-Blind Study (Protocol 01-9001) collaborate in the conduct of the study.
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 | |
UCLA Neurological Services | |
Los Angeles, California, United States, 90095 | |
USC Department of Neurology | |
Los Angeles, California, United States, 90033 | |
United States, Connecticut | |
Yale MS Research Center | |
New Haven, Connecticut, United States, 06520 | |
United States, Maryland | |
The Maryland Center for M.S. | |
Baltimore, Maryland, United States, 21201 | |
United States, Michigan | |
University Health Center 8B | |
Detroit, Michigan, United States, 48201 | |
United States, New Mexico | |
UNM School of Medicine | |
Albuquerque, New Mexico, United States, 87131 | |
United States, New York | |
University of Rochester | |
Rochester, New York, United States, 14642 | |
United States, Pennsylvania | |
Univ. of PA Medical Center, Dept. of Neuro. | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
University of Texas HSC-Houston | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
VA Medical Center | |
Salt Lake City, Utah, United States, 84148 | |
United States, Wisconsin | |
UW Hospital & Clinic | |
Madison, Wisconsin, United States, 53792 |
Study Director: | Kenneth Johnson, MD | University of Maryland |
Responsible Party: | Teva Neuroscience ( J. Michael Nicholas, Ph.D. ) |
Study ID Numbers: | 01-9004 |
Study First Received: | September 12, 2005 |
Last Updated: | September 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00203021 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Demyelinating Diseases Immunologic Factors Diuretics Adjuvants, Immunologic Sclerosis Cardiovascular Agents |
Immunosuppressive Agents Copolymer 1 Multiple Sclerosis Mannitol Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Autoimmune Diseases Immunologic Factors Demyelinating Diseases Immune System Diseases Diuretics, Osmotic Physiological Effects of Drugs Nervous System Diseases Diuretics Adjuvants, Immunologic Sclerosis Cardiovascular Agents |
Immunosuppressive Agents Pharmacologic Actions Copolymer 1 Multiple Sclerosis Pathologic Processes Natriuretic Agents Mannitol Therapeutic Uses Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |