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

W. G. Bradley, G. J. Badger, R. Tandan, M. J. Fillyaw, J. Young, T. J. Fries, P. B. Krusinski, M. Witarsa, J. Boerman, C. J. Blair

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18 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1731-1739
Number of pages9
JournalNeurology
Volume38
Issue number11
StatePublished - Nov 1988
Externally publishedYes

ASJC Scopus subject areas

  • Clinical Neurology

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    Bradley, W. G., Badger, G. J., Tandan, R., Fillyaw, M. J., Young, J., Fries, T. J., Krusinski, P. B., Witarsa, M., Boerman, J., & Blair, C. J. (1988). Double-blind controlled trials of cronassial in chronic neuromuscular diseases and ataxia. Neurology, 38(11), 1731-1739.