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

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.

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 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