Copolymer 1 for Relapsing-Remitting Multiple Sclerosis Treatment
copolymer 1
Autoimmune Diseases+11
+ Demyelinating Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: October 1, 1991
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.250 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Clinically or laboratory-supported definite multiple sclerosis Neurologically stable for at least 30 days prior to entry Expanded Disability Status Scale score no greater than 5 At least 2 documented relapses within 2 years prior to entry Onset of first relapse at least 1 year prior to randomization --Prior/Concurrent Therapy-- Biologic therapy: No prior copolymer 1 Immunosuppressive therapy: No prior cytotoxic immunosuppressives, i.e.: Azathioprine Cyclophosphamide Cyclosporine At least 30 days since corticosteroids Radiotherapy: No prior lymphoid irradiation --Patient Characteristics-- Not HIV or HTLV-I seropositive No insulin-dependent diabetes mellitus No Lyme disease No requirement for aspirin or chronic nonsteroidal anti-inflammatory drugs No pregnant or nursing women Adequate contraception required of fertile women