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

NCT ID: NCT00276315

Last Updated: 2020-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hemifacial Spasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Botulinum toxin type A

Intervention Type BIOLOGICAL

Other Intervention Names

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AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Neurology Department, Peking Union Medical College Hospital

Beijing, , China

Site Status

Neurology Department, Guangdong Provincial People's Hospital

Guangdong, , China

Site Status

Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University

Hangzhou, , China

Site Status

Neurology Department, Shanghai Ruijin Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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A-38-52120-074

Identifier Type: -

Identifier Source: org_study_id

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