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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00276315

Enrollment

332

Registered

2006-01-13

Start date

2005-12-31

Completion date

2007-01-31

Last updated

2020-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

BIOLOGICALBotulinum toxin type A

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026