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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Maryland |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004814 |
OBJECTIVES:
I. Compare tolerance to and therapeutic impact of copolymer 1, a mixture of synthetic polypeptides, with placebo in patients with relapsing-remitting multiple sclerosis.
Condition | Intervention | Phase |
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Multiple Sclerosis |
Drug: copolymer 1 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Estimated Enrollment: | 250 |
Study Start Date: | October 1991 |
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.
One group receives copolymer 1, a mixture of synthetic polypeptides composed of 4 amino acids, subcutaneously each day for 2 years.
The other group receives an injection of placebo daily for 2 years.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Study ID Numbers: | 199/12023, UMB-55901 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004814 History of Changes |
Health Authority: | United States: Federal Government |
multiple sclerosis neurologic and psychiatric disorders rare disease |
Autoimmune Diseases Demyelinating Diseases Immunologic Factors Rare Diseases Adjuvants, Immunologic Sclerosis Multiple Sclerosis, Relapsing-Remitting |
Immunosuppressive Agents Copolymer 1 Multiple Sclerosis Mental Disorders Demyelinating Autoimmune Diseases, CNS 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 |