Clinical Trial: Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of Essential blepharospasm.
Detailed Summary:
Sponsor: Medy-Tox
Current Primary Outcome: the change rate of Jankovic Rating Scale score [ Time Frame: 4weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- the change rate of Jankovic Rating Scale scale [ Time Frame: 0 week, 16weeks(or retreatment point) ]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 [ Time Frame: 0week, 4weeks, 8weeks, 16weeks(or retreatment point) ]To evaluate the change of Blepharospasm Disalbility Index at 4weeks, 8weeks, 16weeks(or retreatment point) post treatment.
- Global assessment about the improvement [ Time Frame: 4weeks ]To evaluate the Global assessment about the improvement at 4weeks post treatment.
- the duration of efficacy [ Time Frame: retreatment point or 16 weeks ]To evaluate the duration of efficacy
Original Secondary Outcome: Same as current
Information By: Medy-Tox
Dates:
Date Received: November 25, 2010
Date Started: August 2010
Date Completion:
Last Updated: April 24, 2012
Last Verified: April 2012