Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia

The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.

Inclusion Criteria:

• Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status
• TWSTRS severity, disability and total scores meeting the defined criteria at baseline

Exclusion Criteria:

• Pure anterocollis or pure retrocollis
• In apparent remission from cervical dystonia
• Previous poor response to the last two botulinum toxin type A or type B treatments
• Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin