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

Phase 3

Completed

• Conditions: Essential Blepharospasm
• Interventions: Drug: Neuronox; Drug: Botox

• Registration Number: NCT03216473
• Lead Sponsor: Medy-Tox

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2016-05-25
• Primary Completion: 2017-03-17
• Status Verified: 2017-07
• Study Completion: 2017-07-04
• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-12
• Last Update Submitted: 2017-07-12
• Study First Posted: 2017-07-13
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuronox	Neuronox	Botulinum Toxin Type A for injection
Botox	Botox	Botulinum Toxin Type A for injection

Primary Outcome Measures

Name	Time	Method
JRS (Jankovic Rating Scale) sum-score	From baseline at 4 week	Change from baseline at 4 week for the JRS (Jankovic Rating Scale) sum-score