Back to resultsClinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Essential Blepharospasm
Primary Purpose
Essential Blepharospasm
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Neuronox
Botox
Sponsored by
About this trial
This is an interventional treatment trial for Essential Blepharospasm
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Neuronox
Botox
Arm Description
Botulinum Toxin Type A for injection
Botulinum Toxin Type A for injection
Outcomes
Primary Outcome Measures
JRS (Jankovic Rating Scale) sum-score
Change from baseline at 4 week for the JRS (Jankovic Rating Scale) sum-score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03216473
Brief Title
Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Essential Blepharospasm
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 25, 2016 (Actual)
Primary Completion Date
March 17, 2017 (Actual)
Study Completion Date
July 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medy-Tox
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in adults with essential blepharospasm.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Blepharospasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neuronox
Arm Type
Experimental
Arm Description
Botulinum Toxin Type A for injection
Arm Title
Botox
Arm Type
Active Comparator
Arm Description
Botulinum Toxin Type A for injection
Intervention Type
Drug
Intervention Name(s)
Neuronox
Other Intervention Name(s)
Botulinum Toxin Type A for injection
Intervention Description
Clostridium Botulinum Toxin A 100 U
Intervention Type
Drug
Intervention Name(s)
Botox
Other Intervention Name(s)
Botulinum Toxin Type A for injection
Intervention Description
Clostridium Botulinum Toxin A 100 U
Primary Outcome Measure Information:
Title
JRS (Jankovic Rating Scale) sum-score
Description
Change from baseline at 4 week for the JRS (Jankovic Rating Scale) sum-score
Time Frame
From baseline at 4 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Essential Blepharospasm
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