Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia

Summary

The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly laterocollis) with the standard initial dose of 500 units Dysport®. The patients will be assigned to one of the two basic types of cervical dystonia, either predominantly rotational torticollis or predominantly laterocollis on the basis of clinical examination. This will determine which therapy is to be administered, using the clearly defined, structured injection protocols.

Timeline

Start

2004-10

Primary completion

2008-02

Completion

2008-04

Outcome

Met primary endpoint

paper At week 4, mean Tsui scores had significantly decreased by -4.01, -3.76 and -4.09 points in the total, torticollis and laterocollis populations, respectively. PMID 22021883 ↗

Publications

• Results Hefter H, Benecke R, Erbguth F, Jost W, Reichel G, Wissel J. An open-label cohort study of the improvement of quality of life and pain in de novo cervical dystonia patients after injections with 500 U botulinum toxin A (Dysport). BMJ Open. 2013 Apr 18;3(4):e001853. doi: 10.1136/bmjopen-2012-001853. Print 2013.
• Results Hefter H, Kupsch A, Mungersdorf M, Paus S, Stenner A, Jost W; Dysport Cervical Dystonia Study Group. A botulinum toxin A treatment algorithm for de novo management of torticollis and laterocollis. BMJ Open. 2011 Jan 1;1(2):e000196. doi: 10.1136/bmjopen-2011-000196.

Drugs

Indications