Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Essential Blepharospasm

NCT ID: NCT03216473

Last Updated: 2017-07-13

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-25

Study Completion Date

2017-07-04

Brief Summary

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This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in adults with essential blepharospasm.

Detailed Description

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Subjects are randomly assigned into the two groups at the ratio of 1:1. The purpose of study is to confirm the non-inferiority of Neuronox to Botox in terms of the efficacy and safety in subjects with essential blepharospasm.

Conditions

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Essential Blepharospasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Neuronox

Botulinum Toxin Type A for injection

Group Type EXPERIMENTAL

Neuronox

Intervention Type DRUG

Clostridium Botulinum Toxin A 100 U

Botox

Botulinum Toxin Type A for injection

Group Type ACTIVE_COMPARATOR

Botox

Intervention Type DRUG

Clostridium Botulinum Toxin A 100 U

Interventions

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Neuronox

Clostridium Botulinum Toxin A 100 U

Intervention Type DRUG

Botox

Clostridium Botulinum Toxin A 100 U

Intervention Type DRUG

Other Intervention Names

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Botulinum Toxin Type A for injection Botulinum Toxin Type A for injection

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 to 75
* Subjects had to have a confirmed clinical diagnosis of essential blepharospasm requiring treatment by injection

Exclusion Criteria

* Subjects who underwent surgical operation
* Subjects with Neuroleptic induced blepharospasm
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medy-Tox

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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TG1221MED

Identifier Type: -

Identifier Source: org_study_id

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