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

Medytox

Status and phase: Completed; Phase 3

Conditions: Essential Blepharospasm

Treatments: Drug: Botox; Drug: Neuronox

Study type: Interventional

Funder types: Industry

Identifiers

NCT03216473

TG1221MED

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Neuronox

Experimental group

Description:

Botulinum Toxin Type A for injection

Treatment:

Drug: Neuronox

Botox

Active Comparator group

Description:

Botulinum Toxin Type A for injection

Treatment:

Drug: Botox