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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. |
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