Volume 20, Issue 7 p. 783-791
Research Article

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 MD

Corresponding Author

Daniel Truong MD

The Parkinson's and Movement Disorders Institute, Fountain Valley, California, USA

The Parkinson's and Movement Disorders Institute, 9940 Talbert Avenue #204, Fountain Valley, CA 92708Search for more papers by this author
Drake D. Duane MD

Drake D. Duane MD

Arizona Dystonia Institute, Scottsdale, Arizona, USA

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Joseph Jankovic MD

Joseph Jankovic MD

Baylor College of Medicine, Houston, Texas, USA

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Carlos Singer MD

Carlos Singer MD

University of Miami School of Medicine, Miami, Florida, USA

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Lauren C. Seeberger MD

Lauren C. Seeberger MD

Colorado Neurological Institute, Englewood, Colorado, USA

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Cynthia L. Comella MD

Cynthia L. Comella MD

Rush University Medical Center, Chicago, Illinois, USA

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Mark F. Lew MD

Mark F. Lew MD

University of Southern California, Los Angeles, California, USA

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Robert L. Rodnitzky MD

Robert L. Rodnitzky MD

University of Iowa, Iowa City, Iowa, USA

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Fabio O. Danisi MD

Fabio O. Danisi MD

Mount Sinai Medical Center, New York, New York, USA

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James P. Sutton MD

James P. Sutton MD

Neurological Research Institute, Encino, California, USA

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P. David Charles MD

P. David Charles MD

Vanderbilt University, Nashville, Tennessee, USA

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Robert A. Hauser MD

Robert A. Hauser MD

University of South Florida, Tampa, Florida, USA

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Geoffrey L. Sheean MD

Geoffrey L. Sheean MD

University of California, San Diego, California, USA

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First published: 25 February 2005
Citations: 188

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 ≤ 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. © 2005 Movement Disorder Society