Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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