A placebo-controlled, double-blind, randomized, two-center, pilot trial of Cop 1 in chronic progressive multiple sclerosis.
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.
Bornstein
M B
MB
Saul R. Korey Department of Neurology, Albert Einstein College of Medicine, Bronx, NY 10461.
Miller
A
A
Slagle
S
S
Weitzman
M
M
Drexler
E
E
Keilson
M
M
Spada
V
V
Weiss
W
W
Appel
S
S
Rolak
L
L
D002908:Chronic Disease; D004185:Disability Evaluation; D004311:Double-Blind Method; D006801:Humans; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000503:physiopathology; D009460:Neurologic Examination; D010455:Peptides / Q000009:adverse effects / Q000627:therapeutic use*; D010865:Pilot Projects; D010919:Placebos; D013256:Steroids / Q000627:therapeutic use; D013997:Time Factors; D016138:Walking
D010455:Peptides; D010919:Placebos; D013256:Steroids; C021759:(T,G)-A-L