Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm

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

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-08-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of Essential blepharospasm.

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Detailed Description

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Conditions

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Essential Blepharospasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Botulinum toxin type A(Meditoxin®)

Group Type EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type DRUG

2 times, Intra-muscular injection, Maximum dosage total 60U

Interventions

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Botulinum Toxin Type A

2 times, Intra-muscular injection, Maximum dosage total 60U

Intervention Type DRUG

Other Intervention Names

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Meditoxin Neuronox

Eligibility Criteria

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Inclusion Criteria

* Men and women aged above 18
* Subjects who was diagnosed with Essential Blepharospasm
* Subjects who voluntarily Signed written informed consent
* Subjects who can adhere to protocol and study requirements

Exclusion Criteria

* Subjects with known history of allergy considered due to Botulinum toxin type A
* Subjects who have received botulinum toxin A type within 3 months
* Any disease that might affect neuromuscular function (e.g.. Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis ect.)
* Subjects who are participating in other clinical trials
* Pregnant or lactating female Subjects
* Subjects who are not eligible for the study at the discretion of the Investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No