Primary results from the cervical dystonia patient registry for observation of onabotulinumtoxina efficacy (CD PROBE).

Published

Journal Article

The Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE; NCT00836017) is a prospective, observational, multicenter, real-world registry designed to assess the safety, effectiveness, and treatment utilization following multiple treatments of onabotulinumtoxinA.Subjects were naïve to botulinum toxin, new to practice, or had not received toxin in ≥ 16 weeks if in a clinical trial. Dosages and treatment intervals varied due to the real-world design. Descriptive and inferential statistics evaluated changes over 3 treatments.1046 subjects enrolled. Subjects were 74.4% female, 63.5% toxin-naïve, mean age 58.0 ± 14.7 years. The mean dose over 2481 treatment sessions was 189. 8 ± 87.1U, with average treatment intervals of 14.6 and 15.1 weeks. The mean Toronto Western Spasmodic Torticollis Rating Scale Total score in subjects who completed all assessments (n=479) decreased from 39.2 at baseline to 27.1 at final visit (P<.0001). A high percentage of physicians reported improvement in Clinician Global Impression of Change after initial assessment; this significantly increased at final assessment (n=479, 91.2% vs 95.0%; P<.0001). Similarly, a high percentage of subjects reported improvement in Patient Global Impression of Change after initial assessment, which significantly increased at final assessment (n=470, 83.0% vs 91.7%; P<.0001). Significant reductions in all Cervical Dystonia Impact Profile-58 scores were observed (n=407). Overall, 26.2% of subjects reported adverse events, including muscular weakness (7.0%) and dysphagia (6.4%).Results indicate robust improvement in clinical ratings and excellent tolerability following onabotulinumtoxinA treatment of CD.

Full Text

Cited Authors

  • Jankovic, J; Adler, CH; Charles, D; Comella, C; Stacy, M; Schwartz, M; Manack Adams, A; Brin, MF

Published Date

  • February 2015

Published In

Volume / Issue

  • 349 / 1-2

Start / End Page

  • 84 - 93

PubMed ID

  • 25595221

Pubmed Central ID

  • 25595221

Electronic International Standard Serial Number (EISSN)

  • 1878-5883

International Standard Serial Number (ISSN)

  • 0022-510X

Digital Object Identifier (DOI)

  • 10.1016/j.jns.2014.12.030

Language

  • eng