Status:
COMPLETED
Assessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm
Lead Sponsor:
Ipsen
Conditions:
Hemifacial Spasm
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Patient suffering from hemifacial spasm with at least 6 months duration (prior to visit 1)
- Cohen scale ≥ to grade II
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT00276315
Start Date
December 1 2005
End Date
January 1 2007
Last Update
April 28 2020
Active Locations (4)
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1
Neurology Department, Peking Union Medical College Hospital
Beijing, China, 100730
2
Neurology Department, Guangdong Provincial People's Hospital
Guangdong, China, 510080
3
Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, China, 310016
4
Neurology Department, Shanghai Ruijin Hospital
Shanghai, China, 200025