A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia

Phase 4 Completed 103 enrolled Seoul National University Hospital Ipsen · collab Medical Research Collaborating Center, Seoul, Korea · collab

RandomizedCrossoverTriple-blindTreatment

Summary

1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia. 2. double blind, randomised, multi center, crossover study

Timeline

Start: 2009-08
Primary completion: 2011-01
Completion: 2011-07

Outcome

Met primary endpoint

paper With regard to safety and efficacy, Dysport was not inferior to Botox in patients with CD at a conversion factor of 2.5:1. PMID 25476727 ↗

Publications

Yun JY, Kim JW, Kim HT, Chung SJ, Kim JM, Cho JW, Lee JY, Lee HN, You S, Oh E, Jeong H, Kim YE, Kim HJ, Lee WY, Jeon BS. Dysport and Botox at a ratio of 2.5:1 units in cervical dystonia: a double-blind, randomized study. Mov Disord. 2015 Feb;30(2):206-13. doi: 10.1002/mds.26085. Epub 2014 Dec 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	200 iu	—
Subject	Botulinum toxin type A	Protein / enzyme biologic	—	—