A placebo-controlled, double-blind, randomized, two-center, pilot trial of Cop 1 in chronic progressive multiple sclerosis
| Autor: | Michael Sela, I. Jacobsohn, Ruth Arnon, Dvora Teitelbaum, S. Slagle, Yadollah Harati, E. Drexler, Loren A. Rolak, M. Keilson, V. Spada, W. Weiss, Murray B. Bornstein, M. Weitzman, S. Brown, A. I. Miller, Stanley H. Appel |
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| Rok vydání: | 1991 |
| Předmět: |
medicine.medical_specialty
Multiple Sclerosis Time Factors Randomization medicine.medical_treatment Pilot Projects Walking Placebo law.invention Placebos Disability Evaluation Double-Blind Method Randomized controlled trial law Internal medicine medicine Humans Neurologic Examination Chemotherapy business.industry Multiple sclerosis Pilot trial medicine.disease Surgery Clinical trial Chronic Disease Steroids Chronic progressive multiple sclerosis Neurology (clinical) Peptides business |
| Zdroj: | Neurology. 41:533-533 |
| ISSN: | 1526-632X 0028-3878 |
| DOI: | 10.1212/wnl.41.4.533 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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