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NEUROLOGY 1988;38:1731
© 1988 American Academy of Neurology

Double-blind controlled trials of Cronassial in chronic neuromuscular diseases and ataxia

W. G. Bradley, DM, FRCP, G. J. Badger, MS, R. Tandan, MD, MRCP, M. J. Fillyaw, RPT, J. Young, MS, T. J. Fries, MD, P. B. Krusinski, BS, M. Witarsa, MD, J. Boennan, RPT and C. J. Blair, BA

Departments of Neurology (Drs. Bradley, Tandan, Fries, and Witarsa, Mr. Fillyaw, and Ms. Krusinski), Medical Biostatistics (Mr. Badger, Mr. Young, and Ms. Blair), and Physical Therapy (Mr. Fillyaw and Ms. Boerman), University of Vermont, Burlington, VT.

We report three 12-month, double-blind, three-phase studies comparing the effect of placebo and 40 mg and 100 mg IM daily of purified bovine brain gangliosides (Cronassial) in chronic neuromuscular diseases. Thirty patients with Charcot-Marie-Tooth disease, 16 with idiopathic polyneuropathy, and 30 with spinocerebellar degeneration had neuromuscular function measured monthly by quantitative testing of motor and sensory function, coordination, and electrophysiologic factors. Analysis of these studies, and of longer term (up to 2 years) open studies of 100 mg daily of Cronassial in 67 patients failed to show therapeutic efficacy of Cronassial. Statistical power calculations indicated that five of the 37 measures had greater than a 70% chance of detecting a 20% difference in the rate of progression of the active-drug and placebo groups. A number of measures significantly improved during prolonged placebo treatment, suggesting that the placebo effect has a strong influence on "objective" measures of neuromuscular function.

Address correspondence and reprint requests to Dr. Bradley, Department of Neurology, 1 South Prospect Street, Burlington, VT 05405.

Supported in part by grants from the US Public Health Service (NO1-NS-4-2371 and GCRC-RR109), the Food and Drug Administration, and the Friedreich's Ataxia Group in America, Inc.

Received March 16, 1988. Accepted for publication in final form May 11, 1988.






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