Efficacy and safety of botulinum type A toxin (Dysport) in cervical Dystonia

Results of the first US randomized, double-blind, placebo-controlled study

Daniel Truong, Drake D. Duane, Joseph Jankovic, Carlos Singer, Lauren C. Seeberger, Cynthia L. Comella, Mark F. Lew, Robert L. Rodnitzky, Fabio O. Danisi, James P. Sutton, P. David Charles, Robert A. Hauser, Geoffrey L. Sheean

Research output: Contribution to journalArticle

157 Citations (Scopus)

Abstract

Botulinum toxin type A (Dysport) has been shown in European studies to be a safe and effective treatment for cervical dystonia. This multicenter, double-blind, randomized, controlled trial assessed the safety and efficacy of Dysport in cervical dystonia patients in the United States. Eighty patients were randomly assigned to receive one treatment with Dysport (500 units) or placebo. Participants were followed up for 4 to 20 weeks, until they needed further treatment. They were assessed at baseline and weeks 2, 4, 8, 12, 16, and 20 after treatment. Dysport was significantly more efficacious than placebo at weeks 4, 8, and 12 as assessed by the Toronto Western Spasmodic Torticollis Rating Scale (10-point vs. 3.8-point reduction in total score, respectively, at week 4; P ≤ 5 0.013). Of participants in the Dysport group, 38% showed positive treatment response, compared to 16% in the placebo group (95% confidence interval, 0.02-0.41). The median duration of response to Dysport was 18.5 weeks. Side effects were generally similar in the two treatment groups; only blurred vision and weakness occurred significantly more often with Dysport. No participants in the Dysport group converted from negative to positive antibodies after treatment. These results confirm previous reports that Dysport (500 units) is safe, effective, and well-tolerated in patients with cervical dystonia.

Original languageEnglish
Pages (from-to)783-791
Number of pages9
JournalMovement Disorders
Volume20
Issue number7
DOIs
StatePublished - Jul 1 2005

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Torticollis
Type A Botulinum Toxins
Placebos
Safety
Therapeutics
abobotulinumtoxinA
Randomized Controlled Trials
Confidence Intervals

Keywords

  • Botulinum toxin
  • Cervical dystonia
  • Clinical trial
  • Dysport
  • Spasmodic torticollis

ASJC Scopus subject areas

  • Clinical Neurology
  • Neuroscience(all)

Cite this

Efficacy and safety of botulinum type A toxin (Dysport) in cervical Dystonia : Results of the first US randomized, double-blind, placebo-controlled study. / Truong, Daniel; Duane, Drake D.; Jankovic, Joseph; Singer, Carlos; Seeberger, Lauren C.; Comella, Cynthia L.; Lew, Mark F.; Rodnitzky, Robert L.; Danisi, Fabio O.; Sutton, James P.; Charles, P. David; Hauser, Robert A.; Sheean, Geoffrey L.

In: Movement Disorders, Vol. 20, No. 7, 01.07.2005, p. 783-791.

Research output: Contribution to journalArticle

Truong, D, Duane, DD, Jankovic, J, Singer, C, Seeberger, LC, Comella, CL, Lew, MF, Rodnitzky, RL, Danisi, FO, Sutton, JP, Charles, PD, Hauser, RA & Sheean, GL 2005, 'Efficacy and safety of botulinum type A toxin (Dysport) in cervical Dystonia: Results of the first US randomized, double-blind, placebo-controlled study', Movement Disorders, vol. 20, no. 7, pp. 783-791. https://doi.org/10.1002/mds.20403
Truong, Daniel ; Duane, Drake D. ; Jankovic, Joseph ; Singer, Carlos ; Seeberger, Lauren C. ; Comella, Cynthia L. ; Lew, Mark F. ; Rodnitzky, Robert L. ; Danisi, Fabio O. ; Sutton, James P. ; Charles, P. David ; Hauser, Robert A. ; Sheean, Geoffrey L. / Efficacy and safety of botulinum type A toxin (Dysport) in cervical Dystonia : Results of the first US randomized, double-blind, placebo-controlled study. In: Movement Disorders. 2005 ; Vol. 20, No. 7. pp. 783-791.
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