Back to resultsSafety and Efficacy of NABOTA in Treatment of Essential Blepharospasm
Primary Purpose
Blepharospasm
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clostridium Botulinum Toxin Type A
Clostridium Botulinum Toxin Type A
Sponsored by
About this trial
This is an interventional treatment trial for Blepharospasm
Eligibility Criteria
Inclusion Criteria:
- Male of female of at least 18 years old
- Grade 2~4 in Scott's scale
Sites / Locations
- the catholic university of korea, Seoul ST. Mary's Hospital.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NABOTA
BOTOX
Arm Description
Single-dose
Single-dose
Outcomes
Primary Outcome Measures
The change from baseline in Scott's Scale Score
Secondary Outcome Measures
Full Information
NCT ID
NCT02947815
First Posted
October 24, 2016
Last Updated
June 25, 2019
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT02947815
Brief Title
Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm
Official Title
A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase II/III Clinical Trial to Compare the Safety and Efficacy of NABOTA Versus BOTOX in Treatment of Essential Blepharospasm
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the Efficacy and Safety of NABOTA in treatment of essential blepharospasm
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharospasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
234 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NABOTA
Arm Type
Experimental
Arm Description
Single-dose
Arm Title
BOTOX
Arm Type
Active Comparator
Arm Description
Single-dose
Intervention Type
Drug
Intervention Name(s)
Clostridium Botulinum Toxin Type A
Other Intervention Name(s)
NABOTA
Intervention Type
Drug
Intervention Name(s)
Clostridium Botulinum Toxin Type A
Other Intervention Name(s)
BOTOX
Primary Outcome Measure Information:
Title
The change from baseline in Scott's Scale Score
Time Frame
At 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male of female of at least 18 years old
Grade 2~4 in Scott's scale
Facility Information:
Facility Name
the catholic university of korea, Seoul ST. Mary's Hospital.
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm
We'll reach out to this number within 24 hrs