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NEUROLOGY 2005;64:1298-1300
© 2005 American Academy of Neurology
Brief Communications

A pilot, double-blind, placebo-controlled trial of indinavir in patients with ALS

S. N. Scelsa, MD, D. J.L. MacGowan, MD, H. Mitsumoto, MD, T. Imperato, RN, A. J. LeValley, MS, M. H. Liu, FNP, M. DelBene, RN and M. Y. Kim, ScD

From Beth Israel Medical Center (Drs. Scelsa and MacGowan, T. Imperato and M.H. Liu) and Columbia University Medical Center (Dr. Mitsumoto, M. DelBene), New York, and Albert Einstein College of Medicine (Drs. Scelsa, MacGowan, and Kim, A.J. LeValley), Bronx, NY.

Address correspondence and reprint requests to Dr. S.N. Scelsa, Neuromuscular Division and ALS Center, Phillips Ambulatory Care Center, Suite 2Q, 10 Union Square East, New York, NY 10003; e-mail: sscelsa{at}bethisraelny.org

There is some evidence of retroviral infection in ALS. A randomized, double-blind, placebo-controlled trial of indinavir in ALS was performed to assess safety and efficacy trends. Nephrolithiasis and gastrointestinal side effects were frequent with indinavir treatment. Group differences in the rate of decline were not significant between the groups for the ALS Functional Rating Scale (p = 0.36) or for the secondary variables. The toxicity and negative efficacy trends discourage further indinavir trials in ALS.

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 April 12 issue to find the title link for this article.

Supported by a grant from the National ALS Association. Merck Pharmaceuticals provided the study medication.

Dr. Scelsa has received honoraria from Aventis Pharmaceuticals for lectures on ALS. Riluzole is discussed in the manuscript.

Presented in part at the Annual American Academy of Neurology Meeting, April 2004, San Francisco, CA.

Received August 20, 2004. Accepted in final form December 13, 2004.




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