A Study Evaluating the Efficacy and Safety of DYSPORT Using 2mL Dilution in Adults with Cervical Dystonia (CD)
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. Up to 132 subjects study-wide will be enrolled with up to six subjects at Rush University Medical Center. Participation in this study will up to 16 weeks with five study visits at Rush. Subjects will be randomized to either active Dysport or placebo. Subjects who complete the study will be offered participate in a open-label extension study where all subjects will received Dysport.
You may be eligible to participate in this study if you:
- Are male or female subjects ≥18 years of age
- Have a primary diagnosis of cervical dystonia at least 18 months since onset and either were previously untreated with botulinum toxin or are 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 have had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles
You will be excluded from this study if you:
- Are in apparent remission from CD
- Have a diagnosis of pure retrocollis or pure anterocollis
- Are a non-naïve subjects and have a previous poor response (as determined by standard practice) to either of the last two Botox treatments for CD
- Have a known requirement of <100 U or >200 U Botox injected into the neck muscles
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.