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Mellen Center for Multiple Sclerosis Treatment and Research (Dr. Goodkin). Cleveland Clinic Foundation, Cleveland, OH; Fargo Clinic (Dr. Bailly), Fargo, ND; Grand Forks Clinic (Dr. Teetzen), Grand Forks, ND; 112 D H Research Statistical Consultants, (Dr. Hertsgaard), Fargo, ND; and the Neuropsychiatric Research Institute and the Department of Psychology (Dr. Beatty), North Dakota State University, Fargo, ND.
We randomized 59 patients with relapsing-remitting multiple sclerosis to receive azathioprine (AZA) 3.0 mg/kg daily or placebo in a double-masked therapeutic trial. Analysis of data for predetermined primary outcome measures demonstrated a significant difference favoring AZA for observed mean exacerbation rate after 2 years of therapy and time to deterioration in both Ambulation Index and Kurtzke Expanded Disability Status Scale score. This study confirms a modest therapeutic benefit for azathioprine previously reported by other investigators.
Address correspondence and reprint requests to Dr. Donald E. Goodkin, Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Foundation, Area U-10, 9500 Euclid Avenue, Cleveland, OH 44195-5244.
Supported in part by the National Multiple Sclerosis Society (RG-1762-A-1). and medications were supplied by the Burroughs Wellcome Company, Research Triangle Park, NC.
Received April 16, 1990. Accepted for publication in final form June 15,1990.
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