Clinical Trial: Assessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Dyspor
Brief 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.
Detailed Summary:
Sponsor: Ipsen
Current Primary Outcome: Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels) [ Time Frame: At the end of week 4 ]
Original Primary Outcome: Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels) at the end of week 4
Current Secondary Outcome:
- Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication) [ Time Frame: At the end of week 1 and 12 ]
- Improvement degree of spasm (Jankovic scale) [ Time Frame: At the end of week 1, 4 and 12 ]
- Assessment of efficacy by the subjects [ Time Frame: At the end of week 1, 4 and 12 ]
Original Secondary Outcome:
- Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication) at the end of week 1 and 12
- Improvement degree of spasm (Jankovic scale) at the end of week 1, 4 and 12
- Assessment of efficacy by the subjects at the end of week 1, 4 and 12
Information By: Ipsen
Dates:
Date Received: January 12, 2006
Date Started: December 2005
Date Completion:
Last Updated: July 23, 2007
Last Verified: July 2007
