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

Inclusion 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