Back to resultsAssessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm
Primary Purpose
Hemifacial Spasm
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
About this trial
This is an interventional treatment trial for Hemifacial Spasm
Eligibility 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
Sites / Locations
- Neurology Department, Peking Union Medical College Hospital
- Neurology Department, Guangdong Provincial People's Hospital
- Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University
- Neurology Department, Shanghai Ruijin Hospital
Outcomes
Primary Outcome Measures
Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00276315
Brief Title
Assessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm
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 Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ipsen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemifacial Spasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
332 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®)
Primary Outcome Measure Information:
Title
Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels)
Time Frame
At the end of week 4
Secondary Outcome Measure Information:
Title
Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication)
Time Frame
At the end of week 1 and 12
Title
Improvement degree of spasm (Jankovic scale)
Time Frame
At the end of week 1, 4 and 12
Title
Assessment of efficacy by the subjects
Time Frame
At the end of week 1, 4 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Neurology Department, Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Neurology Department, Guangdong Provincial People's Hospital
City
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
Neurology Department, Shanghai Ruijin Hospital
City
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Learn more about this trial
Assessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm
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