Skip to main content

Botulinum toxin type B: a double-blind, placebo-controlled, safety and efficacy study in cervical dystonia.

Publication ,  Journal Article
Lew, MF; Adornato, BT; Duane, DD; Dykstra, DD; Factor, SA; Massey, JM; Brin, MF; Jankovic, J; Rodnitzky, RL; Singer, C; Swenson, MR; Tarsy, D ...
Published in: Neurology
September 1997

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.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Neurology

DOI

ISSN

0028-3878

Publication Date

September 1997

Volume

49

Issue

3

Start / End Page

701 / 707

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Torticollis
  • Sickness Impact Profile
  • Severity of Illness Index
  • Placebos
  • Pain Measurement
  • Neurology & Neurosurgery
  • Neck Muscles
  • Middle Aged
  • Male
 

Citation

APA
Chicago
ICMJE
MLA
NLM
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. https://doi.org/10.1212/wnl.49.3.701
Lew, M. F., B. T. Adornato, D. D. Duane, D. D. Dykstra, S. A. Factor, J. M. Massey, M. F. Brin, et al. “Botulinum toxin type B: a double-blind, placebo-controlled, safety and efficacy study in cervical dystonia.Neurology 49, no. 3 (September 1997): 701–7. https://doi.org/10.1212/wnl.49.3.701.
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;49(3):701–7.
Lew, M. F., et al. “Botulinum toxin type B: a double-blind, placebo-controlled, safety and efficacy study in cervical dystonia.Neurology, vol. 49, no. 3, Sept. 1997, pp. 701–07. Pubmed, doi:10.1212/wnl.49.3.701.
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. Botulinum toxin type B: a double-blind, placebo-controlled, safety and efficacy study in cervical dystonia. Neurology. 1997 Sep;49(3):701–707.

Published In

Neurology

DOI

ISSN

0028-3878

Publication Date

September 1997

Volume

49

Issue

3

Start / End Page

701 / 707

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Torticollis
  • Sickness Impact Profile
  • Severity of Illness Index
  • Placebos
  • Pain Measurement
  • Neurology & Neurosurgery
  • Neck Muscles
  • Middle Aged
  • Male