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NEUROLOGY 2004;62:1845-1847
© 2004 American Academy of Neurology
Brief Communications

Placebo-controlled phase I/II studies of minocycline in amyotrophic lateral sclerosis

P. H. Gordon, MD, D. H. Moore, PhD, D. F. Gelinas, MD, C. Qualls, PhD, M. E. Meister, RN, J. Werner, BA, M. Mendoza, PT, J. Mass, RN, G. Kushner, BA and R. G. Miller, MD

From the Department of Neurology (Dr. Gordon), Columbia University, New York, Departments of Neurology (Drs. Gelinas and Miller, M. Mendoza, J. Mass, and G. Kushner) and Biostatistics (Dr. Moore), California Pacific Medical Center, San Francisco, and Departments of Neurology (M.E. Meister and J. Werner) and Biostatistics (Dr. Qualls), University of New Mexico, Albuquerque.

Address correspondence and reprint requests to Dr. P.H. Gordon, Eleanor and Lou Gehrig MDA/ALS Research Center, Neurological Institute, 710 W. 168 St., Box 107, New York, NY 10032; e-mail: pgordon{at}neuro.columbia.edu

Two double-blind, randomized, placebo-controlled feasibility trials of minocycline in ALS were conducted. In Trial 1, 19 subjects received 200 mg/day or placebo for 6 months; there were no significant differences in adverse events (AE). In Trial 2, 23 subjects received up to 400 mg/day in an 8-month crossover trial. The mean tolerated dose was 387 mg/day, there was a trend toward more gastrointestinal AE (p = 0.057), and blood urea nitrogen and liver enzymes became elevated (p < 0.05). Using these data, the authors have designed and launched a phase III trial.

Received October 13, 2003. Accepted in final form December 13, 2003.

Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the May 25 issue to find the title link for this article.

See also page 1766




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