Skip to main content
OpenTrials
Completed

NCT Number: NCT00276315

Assessment of Effectiveness and Safety 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemifacial Spasm Mouth Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neurology Department, Peking Union Medical College Hospital, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A

Biological

Other names: AbobotulinumtoxinA (Dysport®)

Primary outcomes

  1. Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels)

    Time frame: At the end of week 4

Secondary outcomes

  1. Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication)

    Time frame: At the end of week 1 and 12

  2. Improvement degree of spasm (Jankovic scale)

    Time frame: At the end of week 1, 4 and 12

  3. Assessment of efficacy by the subjects

    Time frame: At the end of week 1, 4 and 12

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2007
First posted
Jan 13, 2006
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.