Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple Sclerosis
I. Compare tolerance to and therapeutic impact of copolymer 1, a mixture of synthetic polypeptides, with placebo in patients with relapsing-remitting multiple sclerosis.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||October 1991|
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.
|Study Chair:||Kenneth P. Johnson||University of Maryland|