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From the University of California, San Francisco/Mt. Zion Multiple Sclerosis Center (Dr. Goodkin), San Francisco, CA; and The Mellen Center for Multiple Sclerosis Treatment and Research (Dr. Rudick and M. Daughtry), and the Departments of Biostatistics and Epidemiology (S. VanderBrug Medendorp), and Radiology (Dr. Van Dyke), The Cleveland Clinic Foundation, Cleveland OH.
Supported in part by the National Multiple Sclerosis Society (D.E. Goodkin, MD, PI, RG-2109-A, RG-2109-B). Coded drug and placebo tablets were supplied by American Cyanimid, Pearl River, NY.
Received March 4, 1996. Accepted in final form May 7, 1996.
Address correspondence and reprint requests to Dr Goodkin, The UCSF/Mt. Zion Multiple Sclerosis Center, 1600 Divisadero Street, San Francisco, CA 94115.
We monitored 56 patients with chronic progressive multiple sclerosis (MS) who participated in a clinical trial of weekly, low-dose oral methotrexate with annual gadolinium-enhanced MRIs of the brain (Gd+MRI). None of these patients had clinical exacerbations during the 8 months preceding study entry. We also monitored 35 of these patients with serial Gd+MRIs every 6 weeks for 6 months. We observed a treatment effect, measured by absolute change in T2-weighted total lesion area (T2 W-TLA), in the cohort that completed 6-week scans. We found change in T2 W-TLA in this cohort to be significantly related to sustained change in performance on the nine-hold peg test but not to sustained change on the Expanded Disability Status Scale. Gadolinium enhancement of lesions on 6-week and annual scans was uncommon. Prestudy exacerbation frequency appears to be an important consideration in designing future clinical trials in patients with secondary and primary progressive MS.
NEUROLOGY 1996;47: 1153-1157
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