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 ]

To evaluate the change of JRS(Jankovic Rating Scale) score at 4 weeks post treatment based on baseline( 0 week).


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