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Trial record 1 of 7 for:    "Blepharospasm, Benign Essential" | "Botulinum Toxins, Type A"
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Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Essential Blepharospasm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03216473
Recruitment Status : Completed
First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Essential Blepharospasm Drug: Neuronox Drug: Botox Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 25, 2016
Actual Primary Completion Date : March 17, 2017
Actual Study Completion Date : July 4, 2017

Arm Intervention/treatment
Experimental: Neuronox
Botulinum Toxin Type A for injection
Drug: Neuronox
Clostridium Botulinum Toxin A 100 U
Other Name: Botulinum Toxin Type A for injection

Active Comparator: Botox
Botulinum Toxin Type A for injection
Drug: Botox
Clostridium Botulinum Toxin A 100 U
Other Name: Botulinum Toxin Type A for injection

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

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Responsible Party: Medy-Tox Identifier: NCT03216473     History of Changes
Other Study ID Numbers: TG1221MED
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Botulinum Toxins, Type A
Eyelid Diseases
Eye Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents