Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copoly
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple Sclerosis
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- copolymer 1
Who could take part
Relapsing MS · 18 to 45
Show the full criteria
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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Oct 1991