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

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 348
• Participant gender: Both

Summary

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.

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

Details

• Lead Sponsor: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA
• Last Updated: 2007-07-23

Criteria

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