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

April 27, 2020 updated by: Ipsen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

332

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Neurology Department, Peking Union Medical College Hospital
      • Guangdong, China, 510080
        • Neurology Department, Guangdong Provincial People's Hospital
      • Hangzhou, China, 310016
        • Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University
      • Shanghai, China, 200025
        • Neurology Department, Shanghai Ruijin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels)
Time Frame: At the end of week 4
At the end of week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication)
Time Frame: At the end of week 1 and 12
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
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
At the end of week 1, 4 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion (ACTUAL)

January 1, 2007

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (ESTIMATE)

January 13, 2006

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-38-52120-074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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