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, Carlos Singer, M. R. Swenson, D. Tarsy, J. J. Murray, M. Koller, J. D. Wallace

Research output: Contribution to journalArticle

211 Citations (Scopus)

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
Pages (from-to)701-707
Number of pages7
JournalNeurology
Volume49
Issue number3
StatePublished - Sep 1 1997
Externally publishedYes

Fingerprint

Torticollis
Type A Botulinum Toxins
Placebos
Safety
Sickness Impact Profile
Intramuscular Injections
Pain Measurement
Research Personnel
Outcome Assessment (Health Care)
Pain
Therapeutics
Pharmaceutical Preparations
rimabotulinumtoxinB

ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

Lew, M. F., Adornato, B. T., Duane, D. D., Dykstra, D. D., Factor, S. A., Massey, J. 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.

Botulinum toxin type b : A double-blind, placebo controlled, safety and efficacy study in cervical dystonia. / Lew, Mark 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, Carlos; Swenson, M. R.; Tarsy, D.; Murray, J. J.; Koller, M.; Wallace, J. D.

In: Neurology, Vol. 49, No. 3, 01.09.1997, p. 701-707.

Research output: Contribution to journalArticle

Lew, MF, Adornato, BT, Duane, DD, Dykstra, DD, Factor, SA, Massey, JM, Brin, MF, Jankovic, J, Rodnitzky, RL, Singer, C, Swenson, MR, Tarsy, D, Murray, JJ, Koller, M & Wallace, JD 1997, 'Botulinum toxin type b: A double-blind, placebo controlled, safety and efficacy study in cervical dystonia', Neurology, vol. 49, no. 3, pp. 701-707.
Lew MF, Adornato BT, Duane DD, Dykstra DD, Factor SA, Massey JM et al. Botulinum toxin type b: A double-blind, placebo controlled, safety and efficacy study in cervical dystonia. Neurology. 1997 Sep 1;49(3):701-707.
Lew, Mark 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, Carlos ; Swenson, M. R. ; Tarsy, D. ; Murray, J. J. ; Koller, M. ; Wallace, J. D. / Botulinum toxin type b : A double-blind, placebo controlled, safety and efficacy study in cervical dystonia. In: Neurology. 1997 ; Vol. 49, No. 3. pp. 701-707.
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