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Branched-chain amino acids and amyotrophic lateral sclerosis

A treatment failure?

We initiated a double-blind, placebo-controlled trial to test the efficacy and safety of branched-chain amino acids (BCAA) (L-leucine 12 g, L-isoleucine 6 g, and L-valine 6 g daily) in amyotrophic lateral sclerosis (ALS) patients. There was an excess mortality in subjects randomized to active treatment (24 BCAA, 13 placebo) when a total of 126 ALS patients had been recruited. This finding, associated with the lack of efficacy of BCAA (measured by comparing the disability scales in the two treatment groups), led the Data Monitoring Committee to require cessation of the trial.

Address correspondence and reprint requests to Dr. Ettore Beghi at Istituto di Ricerche Farmacologiche "Mario Negri" Via Eritrea 62, 20157 Milan, Italy.

^*See page 2469 for Study Group participants.

This study was undertaken and conducted in concord with the SPECIALS collaboration.⁵

Supported by Bracco S.p.A.

Presented in part at the 44th annual meeting of the American Academy of Neurology in San Diego, CA, May 1992.

Received November 4, 1992. Accepted for publication in final form May 2, 1993.

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