Assessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm

A Phase III, Multicentre, Randomised, Assessor-blind, Parallel Groups, Reference Drug Controlled Study to Assess the Efficacy and Safety of a Single Administration, by Subcutaneous Injection of Dysport® for the Treatment of Hemifacial Spasm

To compare the effectiveness and safety of Dysport® with the domestic Botulinum Toxin Type A (manufactured by Lanzhou Biologic Product Institute, P.R. China) for the treatment of hemifacial spasm.

Inclusion Criteria:

• Patient suffering from hemifacial spasm with at least 6 months duration (prior to visit 1)
• Cohen scale ≥ to grade II

Exclusion Criteria:

• Botulinum toxin type A treatment history within last 16 weeks prior to visit 1
• Hemifacial spasm secondary to facial palsy
• Previous alcohol or phenol injections or surgical therapy of the facial muscles
• Requirement for botulinum toxin injection to site(s) of the body other than in this study