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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00276315
First received: January 12, 2006
Last updated: July 23, 2007
Last verified: July 2007
History of Changes
  Purpose

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:

MedlinePlus related topics: Botox
U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276315

Locations
China
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
Ipsen
Investigators
Study Director: Jing-dong Ma, MD Ipsen
  More Information

No publications provided

ClinicalTrials.gov 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:
Spasm
Hemifacial Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
 Stomatognathic Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013