Back to resultsEfficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm
Primary Purpose
Essential Blepharospasm
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sponsored by
About this trial
This is an interventional treatment trial for Essential Blepharospasm
Eligibility Criteria
Inclusion Criteria:
- Men and women aged above 18
- Subjects who was diagnosed with Essential Blepharospasm
- Subjects who voluntarily Signed written informed consent
- Subjects who can adhere to protocol and study requirements
Exclusion Criteria:
- Subjects with known history of allergy considered due to Botulinum toxin type A
- Subjects who have received botulinum toxin A type within 3 months
- Any disease that might affect neuromuscular function (e.g.. Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis ect.)
- Subjects who are participating in other clinical trials
- Pregnant or lactating female Subjects
- Subjects who are not eligible for the study at the discretion of the Investigator.
Sites / Locations
- Sevrance Hospital
- Seoul St.Mary Hospital
- Chung-Ang Univesity Yongsan Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Botulinum toxin type A(Meditoxin®)
Arm Description
Outcomes
Primary Outcome Measures
the change rate of Jankovic Rating Scale score
To evaluate the change of JRS(Jankovic Rating Scale) score at 4 weeks post treatment based on baseline( 0 week).
Secondary Outcome Measures
the change rate of Jankovic Rating Scale scale
To evaluate the change of JRS(Jankovic Rating Scale) at retreatment point or 16 weeks post treatment based on Baseline(0 week).
the change rate of Blepharospasm Disability Index
To evaluate the change of Blepharospasm Disalbility Index at 4weeks, 8weeks, 16weeks(or retreatment point) post treatment.
Global assessment about the improvement
To evaluate the Global assessment about the improvement at 4weeks post treatment.
the duration of efficacy
To evaluate the duration of efficacy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01259557
Brief Title
Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm
Official Title
Multi-center, Phase Ⅳ, Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Meditoxin® in Subjects With Essential Blepharospasm
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medy-Tox
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of 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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botulinum toxin type A(Meditoxin®)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
Meditoxin, Neuronox
Intervention Description
2 times, Intra-muscular injection, Maximum dosage total 60U
Primary Outcome Measure Information:
Title
the change rate of Jankovic Rating Scale score
Description
To evaluate the change of JRS(Jankovic Rating Scale) score at 4 weeks post treatment based on baseline( 0 week).
Time Frame
4weeks
Secondary Outcome Measure Information:
Title
the change rate of Jankovic Rating Scale scale
Description
To evaluate the change of JRS(Jankovic Rating Scale) at retreatment point or 16 weeks post treatment based on Baseline(0 week).
Time Frame
0 week, 16weeks(or retreatment point)
Title
the change rate of Blepharospasm Disability Index
Description
To evaluate the change of Blepharospasm Disalbility Index at 4weeks, 8weeks, 16weeks(or retreatment point) post treatment.
Time Frame
0week, 4weeks, 8weeks, 16weeks(or retreatment point)
Title
Global assessment about the improvement
Description
To evaluate the Global assessment about the improvement at 4weeks post treatment.
Time Frame
4weeks
Title
the duration of efficacy
Description
To evaluate the duration of efficacy
Time Frame
retreatment point or 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women aged above 18
Subjects who was diagnosed with Essential Blepharospasm
Subjects who voluntarily Signed written informed consent
Subjects who can adhere to protocol and study requirements
Exclusion Criteria:
Subjects with known history of allergy considered due to Botulinum toxin type A
Subjects who have received botulinum toxin A type within 3 months
Any disease that might affect neuromuscular function (e.g.. Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis ect.)
Subjects who are participating in other clinical trials
Pregnant or lactating female Subjects
Subjects who are not eligible for the study at the discretion of the Investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaechan Kim, M.D., Ph.D.
Organizational Affiliation
Chung-Ang university Yongsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sevrance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Seoul St.Mary Hospital
City
Seoul
ZIP/Postal Code
137-040
Country
Korea, Republic of
Facility Name
Chung-Ang Univesity Yongsan Hospital
City
Seoul
ZIP/Postal Code
140-883
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm
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