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

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

Study Overview

• Status: Completed
• Conditions: Essential Blepharospasm
• Intervention / Treatment: Drug: Neuronox; Drug: Botox

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuronox; Botulinum Toxin Type A for injection	Drug: Neuronox; Clostridium Botulinum Toxin A 100 U; Other Names: Botulinum Toxin Type A for injection
Active Comparator: Botox; Botulinum Toxin Type A for injection	Drug: Botox; Clostridium Botulinum Toxin A 100 U; Other Names: Botulinum Toxin Type A for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medy-Tox

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2016
• Primary Completion (Actual): March 17, 2017
• Study Completion (Actual): July 4, 2017

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharospasm; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: TG1221MED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No