Botulinum toxin type b: A double-blind, placebo controlled, safety and efficacy study in cervical dystonia

Mark F. Lew, B. T. Adornato, D. D. Duane, D. D. Dykstra, S. A. Factor, J. M. Massey, M. F. Brin, J. Jankovic, R. L. Rodnitzky, C. Singer, M. R. Swenson, D. Tarsy, J. J. Murray, M. Koller, J. D. Wallace

Research output: Contribution to journalArticle

212 Scopus citations

Abstract

We enrolled and treated 122 patients with idiopathic cervical dystonia in a double-blind, placebo-controlled safety and efficacy study of botulinum toxin type B (BotB). Both A-responsive and A-resistant patients were enrolled. Patients received intramuscular injections of either BotB (2,500 U, 5,000 U, or 10,000 U) or placebo. The primary outcome measure of efficacy was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score at 4 weeks following study drug administration. Secondary measures of efficacy were TWSTRS-Severity, -Disability, and -Pain subscale scores, and Analog Pain Assessment, Investigator Global Assessment. Patient Global Assessment, and Sickness Impact Profile scores. Duration of effect was estimated with an intent-to-treat analysis of responders. Safety measures included clinical parameters, laboratory tests, and adverse events. The primary and most of the secondary analyses indicated a statistically significant treatment effect and a dose response. BotB is safe, well tolerated, and efficacious in the treatment of cervical dystonia at the doses tested.

Original languageEnglish (US)
Pages (from-to)701-707
Number of pages7
JournalNeurology
Volume49
Issue number3
DOIs
StatePublished - Sep 1997
Externally publishedYes

ASJC Scopus subject areas

  • Clinical Neurology

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    Lew, M. F., Adornato, B. T., Duane, D. D., Dykstra, D. D., Factor, S. A., Massey, J. M., Brin, M. F., Jankovic, J., Rodnitzky, R. L., Singer, C., Swenson, M. R., Tarsy, D., Murray, J. J., Koller, M., & Wallace, J. D. (1997). Botulinum toxin type b: A double-blind, placebo controlled, safety and efficacy study in cervical dystonia. Neurology, 49(3), 701-707. https://doi.org/10.1212/WNL.49.3.701