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

A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of NEURONOX® vs. BOTOX® in Patients With Essential Blepharospasm

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03216473

Enrollment

140

Registered

2017-07-13

Start date

2016-05-25

Completion date

2017-07-04

Last updated

2017-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Blepharospasm

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.

Interventions

DRUGNeuronox

Clostridium Botulinum Toxin A 100 U

DRUGBotox

Clostridium Botulinum Toxin A 100 U

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026