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NEUROLOGY 2006;66:1117-1119
© 2006 American Academy of Neurology
Brief Communications

Randomized controlled phase II trial of glatiramer acetate in ALS

P. H. Gordon, MD, C. Doorish, BA, J. Montes, PT, MA, R. L. Mosley, PhD, B. Diamond, PhD, R. B. MacArthur, PharmD, L. H. Weimer, MD, P. Kaufmann, MD, MS, A. P. Hays, MD, L. P. Rowland, MD, H. E. Gendelman, MD, S. Przedborski, MD, PhD and H. Mitsumoto, MD, DSci

From the Departments of Neurology (P.H.G., C.D., J.M., L.H.W., P.K., L.P.R., S.P., H.M.), Pharmacology (R.B.M.), Pathology (A.P.H.), and Biostatistics at the General Clinical Research Center (B.D.), Columbia University, NY; and the Department of Pharmacology and Experimental Neuroscience, Center for Neurovirology and Neurodegenerative Disorders (R.L.M., H.E.G.), University of Nebraska Medical Center, Omaha, NE.

Address correspondence and reprint requests to Dr. Paul H. Gordon, Eleanor and Lou Gehrig MDA/ALS Research Center, Neurological Institute, 9th Floor, 710 West 168th Street, New York, NY 10032; e-mail: phg8{at}columbia.edu

The authors conducted a randomized controlled trial to test the safety and immunology of glatiramer acetate in ALS. Twenty treated patients were randomly assigned to daily or biweekly injections. Ten control patients were selected from another trial and followed up concurrently. Injection reactions were the only common adverse event (p = 0.01). Treated patients showed enhanced lymphocyte proliferation (p = 0.02). The safety profile and immune effects support conducting larger trials of dose selection and efficacy.

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 11 issue to find the title link for this article.

Supported by GCRC Grant # 3301, NIH P01 NS11766-27A1, P01 NS43985, R21 NS049264, MDA Wings Over Wall Street, and Michael Gluck, Marsha and Alan Baer, and the Frani and Louis Blumkin Foundations, 2R37 NS36126. Drs. Gordon and Mitsumoto received a single consulting honorarium of less than $10,000 following the trial.

Disclosure: Study was partially funded by Teva Pharmaceuticals. The authors report no conflicts of interest.

Received September 12, 2005. Accepted in final form December 27, 2005.






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