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

Walter 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

Research output: Contribution to journalArticle

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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
Pages (from-to)1731-1739
Number of pages9
JournalNeurology
Volume38
Issue number11
StatePublished - Jan 1 1988
Externally publishedYes

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Neuromuscular Diseases
Ataxia
Placebo Effect
Chronic Disease
Placebos
Spinocerebellar Degenerations
Charcot-Marie-Tooth Disease
Polyneuropathies
Gangliosides
Brain
Therapeutics
Pharmaceutical Preparations
cronassial

ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

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

Double-blind controlled trials of Cronassial in chronic neuromuscular diseases and ataxia. / Bradley, Walter G; Badger, G. J.; Tandan, R.; Fillyaw, M. J.; Young, J.; Fries, T. J.; Krusinski, P. B.; Witarsa, M.; Boerman, J.; Blair, C. J.

In: Neurology, Vol. 38, No. 11, 01.01.1988, p. 1731-1739.

Research output: Contribution to journalArticle

Bradley, WG, Badger, GJ, Tandan, R, Fillyaw, MJ, Young, J, Fries, TJ, Krusinski, PB, Witarsa, M, Boerman, J & Blair, CJ 1988, 'Double-blind controlled trials of Cronassial in chronic neuromuscular diseases and ataxia', Neurology, vol. 38, no. 11, pp. 1731-1739.
Bradley WG, Badger GJ, Tandan R, Fillyaw MJ, Young J, Fries TJ et al. Double-blind controlled trials of Cronassial in chronic neuromuscular diseases and ataxia. Neurology. 1988 Jan 1;38(11):1731-1739.
Bradley, Walter G ; Badger, G. J. ; Tandan, R. ; Fillyaw, M. J. ; Young, J. ; Fries, T. J. ; Krusinski, P. B. ; Witarsa, M. ; Boerman, J. ; Blair, C. J. / Double-blind controlled trials of Cronassial in chronic neuromuscular diseases and ataxia. In: Neurology. 1988 ; Vol. 38, No. 11. pp. 1731-1739.
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