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

Hemifacial Spasm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276315
• Other study ID #: A-38-52120-074
• Status: Completed
• Phase: Phase 3
• Start date: December 2005
• Est. completion date: January 2007

Study information

• Verified date: April 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemifacial Spasm
• Spasm

Intervention

Biological:
• Botulinum toxin type A

Locations

Country	Name	City	State
China	Neurology Department, Peking Union Medical College Hospital	Beijing
China	Neurology Department, Guangdong Provincial People's Hospital	Guangdong
China	Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University	Hangzhou
China	Neurology Department, Shanghai Ruijin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of responders (defined as Cohen scale improvement = to 2 levels)		At the end of week 4
Secondary	Percentage of responders (defined as Cohen scale improvement = to 2 levels after medication)		At the end of week 1 and 12
Secondary	Improvement degree of spasm (Jankovic scale)		At the end of week 1, 4 and 12
Secondary	Assessment of efficacy by the subjects		At the end of week 1, 4 and 12