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OpenTrials
Completed

NCT Number: NCT03216473

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

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

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Key information

Conditions

Essential Blepharospasm Benign essential blepharospasm

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuronox

Drug

Clostridium Botulinum Toxin A 100 U

Other names: Botulinum Toxin Type A for injection

Botox

Drug

Clostridium Botulinum Toxin A 100 U

Other names: Botulinum Toxin Type A for injection

Primary outcomes

  1. JRS (Jankovic Rating Scale) sum-score

    Time frame: From baseline at 4 week

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

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 13, 2017
Registry last updated
Jul 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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