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

Essential Blepharospasm Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03216473
• Other study ID #: TG1221MED
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2017
• Last updated: July 12, 2017
• Start date: May 25, 2016
• Est. completion date: July 4, 2017

Study information

• Verified date: July 2017
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 4, 2017
• Est. primary completion date: March 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Blepharospasm
• Essential Blepharospasm

Intervention

Drug:
• Neuronox
Clostridium Botulinum Toxin A 100 U
• Botox
Clostridium Botulinum Toxin A 100 U

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	JRS (Jankovic Rating Scale) sum-score	Change from baseline at 4 week for the JRS (Jankovic Rating Scale) sum-score	From baseline at 4 week