A Randomised Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT Using 2mL Dilution in Adults With Cervical Dystonia (CD).



Status:Completed
Conditions:Neurology, Orthopedic, Women's Studies
Therapuetic Areas:Neurology, Orthopedics / Podiatry, Reproductive
Healthy:No
Age Range:18 - Any
Updated:11/8/2014
Start Date:January 2013
End Date:September 2014
Contact:Ipsen Recruitment Enquiries
Email:clinical.trials@ipsen.com

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A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT Using 2mL Dilution in Adults With Cervical Dystonia.

The purpose of the protocol is to evaluate the efficacy of Dysport using 2 mL dilution
compared with placebo for the treatment of Cervical Dystonia.


Inclusion Criteria:

- Primary diagnosis of Cervical Dystonia at least 9 months since onset and either
previously untreated with botulinum toxin or currently treated with Botox at a total
dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last
injection cycle, and having had a satisfactory treatment response in the principal
investigator's judgment during the last two sequential Botox treatment cycles.

- TWSTRS total score≥ 20; TWSTRS-severity subscale score> 10;

Exclusion Criteria:

- In apparent remission from Cervical Dystonia

- Diagnosis of pure retrocollis or pure anterocollis

- For non-naïve subjects, previous poor response to either of the last two Botox
treatments

- Known requirement of <100U or >200U of Botox injected into the neck muscles
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