Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, neurologic and psychiatric disorders, rare disease
Brief 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.
Detailed description
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.
Interventions
DRUGcopolymer 1
Sponsors
University of Maryland
National Center for Research Resources (NCRR)
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Outcome results
None listed