A placebo-controlled, double-blind, randomized, two-center, pilot trial of Cop 1 in chronic progressive multiple sclerosis

Neurology. 1991 Apr;41(4):533-9. doi: 10.1212/wnl.41.4.533.

Abstract

We found Cop 1 to be effective and relatively safe in a previous (exacerbating-remitting) clinical trial. This current trial involves 106 chronic-progressive patients. The major end point, confirmed progression of 1.0 or 1.5 units (depending on baseline disability) on the Kurtzke Expanded Disability Status Scale, was observed in nine (17.6%) treated and 14 (25.5%) control patients. The differences between the overall survival curves were not significant. Progression rates at 12 and 24 months were higher for the placebo group (p = 0.088) with 2-year probabilities of progressing of 20.4% for Cop 1 and 29.5% for placebo. We found a significant difference at 24 months between placebo and Cop 1 at one but not the other center. Two-year progression rates for two secondary end points, unconfirmed progression, and progression of 0.5 EDSS units, (p = 0.03) are significant.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Chronic Disease
  • Disability Evaluation
  • Double-Blind Method
  • Humans
  • Multiple Sclerosis / drug therapy*
  • Multiple Sclerosis / physiopathology
  • Neurologic Examination
  • Peptides / adverse effects
  • Peptides / therapeutic use*
  • Pilot Projects
  • Placebos
  • Steroids / therapeutic use
  • Time Factors
  • Walking

Substances

  • Peptides
  • Placebos
  • Steroids
  • (T,G)-A-L