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