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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00276315
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : April 28, 2020
Sponsor:
Information provided by:
Ipsen

Tracking Information
First Submitted Date  ICMJE January 12, 2006
First Posted Date  ICMJE January 13, 2006
Last Update Posted Date April 28, 2020
Study Start Date  ICMJE December 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2007)
Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels) [ Time Frame: At the end of week 4 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2006)
Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels) at the end of week 4
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2007)
  • Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication) [ Time Frame: At the end of week 1 and 12 ]
  • Improvement degree of spasm (Jankovic scale) [ Time Frame: At the end of week 1, 4 and 12 ]
  • Assessment of efficacy by the subjects [ Time Frame: At the end of week 1, 4 and 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2006)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Hemifacial Spasm
Intervention  ICMJE Biological: Botulinum toxin type A
Other Name: AbobotulinumtoxinA (Dysport®)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2020)
332
Original Enrollment  ICMJE
 (submitted: January 12, 2006)
348
Actual Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00276315
Other Study ID Numbers  ICMJE A-38-52120-074
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Ipsen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP