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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborators: University of Maryland; University of Maryland, College Park
• Treatments: (T,G)-A-L; Glatiramer Acetate

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