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CompletedNCT03216473Updated Jul 13, 2017

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

A Phase 3 interventional study of Neuronox and Botox in Essential Blepharospasm, sponsored by Medy-Tox. Completed. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-13.

Sponsored by Medy-Tox · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

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

Read the 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.

02

Conditions studied

  • Essential Blepharospasm

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03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

Exclusion Criteria:

  • Subjects who underwent surgical operation
  • Subjects with Neuroleptic induced blepharospasm
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    Neuronox

    Botulinum Toxin Type A for injection

    Drug: Neuronox

  • Active comparator
    Botox

    Botulinum Toxin Type A for injection

    Drug: Botox

Interventions

  • DrugNeuronox

    Clostridium Botulinum Toxin A 100 U

    Also known as: Botulinum Toxin Type A for injection

  • DrugBotox

    Clostridium Botulinum Toxin A 100 U

    Also known as: Botulinum Toxin Type A for injection

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What researchers measure

Primary outcomes

  1. JRS (Jankovic Rating Scale) sum-score

    Change from baseline at 4 week for the JRS (Jankovic Rating Scale) sum-score

    Time frame: From baseline at 4 week

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03216473
Lead sponsor
Medy-Tox
Responsible party
Sponsor
First posted
Jul 13, 2017
Start date
May 25, 2016
Primary completion
Mar 17, 2017
Completion
Jul 4, 2017
Last update
Jul 13, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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