Assessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm
Phase 3
Completed
- Conditions
- Hemifacial Spasm
- Registration Number
- NCT00276315
- Lead Sponsor
- Ipsen
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 332
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels) At the end of week 4
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
Neurology Department, Guangdong Provincial People's Hospital
🇨🇳Guangdong, China
Neurology Department, Peking Union Medical College Hospital
🇨🇳Beijing, China
Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University
🇨🇳Hangzhou, China
Neurology Department, Shanghai Ruijin Hospital
🇨🇳Shanghai, China