Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple Sclerosis

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