Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm
Multi-center, Phase Ⅳ, Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Meditoxin® in Subjects With Essential Blepharospasm
1 other identifier
interventional
110
1 country
3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of Essential blepharospasm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2010
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 25, 2010
CompletedFirst Posted
Study publicly available on registry
December 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedApril 25, 2012
April 1, 2012
9 months
November 25, 2010
April 24, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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).
4weeks
Secondary Outcomes (4)
the change rate of Jankovic Rating Scale scale
0 week, 16weeks(or retreatment point)
the change rate of Blepharospasm Disability Index
0week, 4weeks, 8weeks, 16weeks(or retreatment point)
Global assessment about the improvement
4weeks
the duration of efficacy
retreatment point or 16 weeks
Study Arms (1)
Botulinum toxin type A(Meditoxin®)
EXPERIMENTALInterventions
2 times, Intra-muscular injection, Maximum dosage total 60U
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medy-Toxlead
Study Sites (3)
Sevrance Hospital
Seoul, 120-752, South Korea
Seoul St.Mary Hospital
Seoul, 137-040, South Korea
Chung-Ang Univesity Yongsan Hospital
Seoul, 140-883, South Korea
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaechan Kim, M.D., Ph.D.
Chung-Ang university Yongsan Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 25, 2010
First Posted
December 14, 2010
Study Start
August 1, 2010
Primary Completion
May 1, 2011
Study Completion
August 1, 2011
Last Updated
April 25, 2012
Record last verified: 2012-04