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

This study has been completed.
Information provided by:
Ipsen Identifier:
First received: January 12, 2006
Last updated: July 23, 2007
Last verified: July 2007
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.

Condition Intervention Phase
Hemifacial Spasm
Drug: Botulinum type A toxin (Dysport®) - one single injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels) [ Time Frame: At the end of week 4 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 348
Study Start Date: December 2005
Study Completion Date: January 2007

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00276315

Neurology Department, Peking Union Medical College Hospital
Beijing, China, 100730
Neurology Department, Guangdong Provincial People's Hospital
Guangdong, China, 510080
Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, China, 310016
Neurology Department, Shanghai Ruijin Hospital
Shanghai, China, 200025
Sponsors and Collaborators
Study Director: Jing-dong Ma, MD Ipsen
  More Information Identifier: NCT00276315     History of Changes
Other Study ID Numbers: A-38-52120-074 
Study First Received: January 12, 2006
Last Updated: July 23, 2007
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hemifacial Spasm
Mouth Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms
Stomatognathic Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on May 05, 2016