The purpose of this study is evaluate the efficacy and safety of Botulax® in the treatment of Essential blepharospasm.
Multi-center, single arm, open-label, Phase IV clinical trial to evaluate the efficacy and safety of Botulax® in Subjects with essential blepharospasm
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
249
Recommended initial dose to be intra-muscularly injected to the medial and contralateral pretarsal orbicularis oculi of the upper eyelid and the contralateral pretarsal orbicularis oculi of the lower eyelid is 1.25-2.5U (0.05ml \~ 0.1ml per site).
Hugel
Seoul, Korea, South Korea
Total score change from baseline at 4 weeks post-injection of Jankovic Rating scale
To evaluate the change of JRS (Jankovic Rating scale) score at 4 weeks post treatment based on baseline(0 week). JRS total score will be calculated as the sum (0\~8) of two sub-scores of severity and frequency (0\~4 each for severity and frequency) of blepharospasm.
Time frame: At 4 weeks post-injection
Total score change from baseline at 16 weeks post-injection of Jankovic Rating scale
To evaluate the change of JRS (Jankovic Rating scale) score at 16 weeks post treatment based on baseline(0 week)
Time frame: At 0 weeks and 16 weeks post-injection
Change from baseline at 4 weeks and 16 weeks of Disability Index
To evaluate the change of Blepharospasm Disability Index at 4 weeks and 16 weeks post treatment. Functional disability assessment scale will be assessed as functional disability score. Functional disability assessment scale consists of 6 daily activities (reading, watching television, household activities (cleaning, etc.), mobility, driving, work).
Time frame: At 4 weeks and 16 weeks post-injection
Global Response evaluated by investigator at 4 weeks and 16 weeks after post-injection
To evaluate the Investigator's assessment of global response at Weeks 4 and 16 after treatment. At Weeks 4 and 16 Visits after treatment, the investigator will assess global response on a 9-point scale from -4 (marked worsening) to +4 (Complete abolition of all signs and symptoms).
Time frame: At 4 weeks and 16 weeks post-injection
Change from baseline at 4 weeks and 16 weeks of WHO-Quality of Life(QOL)
To evaluate the change in WHO-Quality of Life (QoL) at Weeks 4 and 16 after treatment from baseline WHOQOL will be assessed by the brief Korean version of WHOQOL (WHOQOL-BREF). The Korean WHOQOL-BREF consists of a total of 26 subscales in 4 domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Items in each subscale are in a range from 1 (not at all or very dissatisfied) to 5 (very much or very satisfied).
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Time frame: At 4 weeks and 16 weeks post-injection