Assessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm
Information source: Ipsen
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemifacial Spasm
Intervention: Botulinum type A toxin (Dysport®) - one single injection (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Ipsen Official(s) and/or principal investigator(s):
Jing-dong Ma, MD, Study Director, Affiliation: Ipsen
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.
Clinical Details
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 Dysport® for the Treatment of Hemifacial Spasm
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels)
Secondary outcome: Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication)Improvement degree of spasm (Jankovic scale) Assessment of efficacy by the subjects
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Neurology Department, Peking Union Medical College Hospital, Beijing 100730, China
Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou 310016, China
Neurology Department, Shanghai Ruijin Hospital, Shanghai 200025, China
Neurology Department, Guangdong Provincial People's Hospital, Guangdong 510080, China
Additional Information
Starting date: December 2005
Ending date: January 2007
Last updated: July 23, 2007
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