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

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ClinicalTrials.gov Identifier: NCT03216473
Recruitment Status : Completed
First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

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
Criteria

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
ClinicalTrials.gov 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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Blepharospasm
Eyelid Diseases
Eye Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
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