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

Medy-Tox140 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

140

Conditions

Essential Blepharospasm

Interventions

NeuronoxDRUG

Clostridium Botulinum Toxin A 100 U

BotoxDRUG

Clostridium Botulinum Toxin A 100 U

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

JRS (Jankovic Rating Scale) sum-score

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

Time frame: From baseline at 4 week

Data from ClinicalTrials.gov

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