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

Ipsen332 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

332

Conditions

Hemifacial Spasm

Interventions

Botulinum toxin type ABIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

Neurology Department, Peking Union Medical College Hospital

Beijing, China

Neurology Department, Guangdong Provincial People's Hospital

Guangdong, China

Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University

Hangzhou, China

Neurology Department, Shanghai Ruijin Hospital

Shanghai, China

Outcomes

Primary Outcomes

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

Time frame: At the end of week 4

Secondary Outcomes

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

Data from ClinicalTrials.gov

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