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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin Type A (Botulax) | Experimental | Botulinum Toxin Type A (Botulax) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 4 weeks post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | At 0 weeks and 16 weeks post-injection |
| Change from baseline at 4 weeks and 16 weeks of Disability Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hugel | Seoul | Korea | 06162 | South Korea |
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| ID | Term |
|---|---|
| C535428 | Benign essential blepharospasm |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
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). |
| 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). | 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). | At 4 weeks and 16 weeks post-injection |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |