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

Ipsen

Status and phase

Completed

Phase 3

Conditions

Hemifacial Spasm

Treatments

Biological: Botulinum toxin type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00276315

A-38-52120-074

Details and patient eligibility

About

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.

Enrollment

332 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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