Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of Hugeltox Inj. in Essential Blepharospasm

Study Overview
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Brief Summary
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To compare the efficacy and safety of Hugel-Tox (Botulinum toxin A, Hugel, Korea) against Botox in the treatment of Essential Blepharospasm and to get a regulatory approval from KFDA

Official Title
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Double-blinded, Randomized, Active Control Comparative, Parallel-designed, Phase III Clinical Trial: Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of Hugeltox Inj. In Essential Blepharospasm Running Parallel With Phase I Study

Conditions
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Essential Blepharospasm

Intervention / Treatment
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* Drug: Hugeltox
* Drug: Botulinum Toxin Type A(Botox®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult between ages 18 and 75 years All patients, diagnosed of essential blepharospasm, with Grade 2 4 of Severity of Spmasm (by Scott's Method) Exclusion Criteria: Patients have undergone surgical surgery to treat blepharospmasm like myectomy or neurectomy Patients with hypersensitivity history to botulinum toxin products previously Patients with secondary blepharomspasm Patients with hemifacialspasm Patients with treatment following drugs ; Anticonvulsants, tranquilizers, narcotics, aminoglycoside antibiotics, muscle relaxtants like baclofen etc., blockers of parasympathetic nervous system, levodopa Patients with previous injection of other botulinum toxin products in 3 months Patients with any other significant neuromuscular disease like Myasthenia gravis Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Botulinum toxin type A(Botox®)<br>Botulinum toxin type A(Botox®) | Drug: Hugeltox<br>* 1.25U 2.5U/site, Maximum dosage 12.5U 60U/person<br>Drug: Botulinum Toxin Type A(Botox®)<br>* 1.25U 2.5U/site, Maximum dosage 12.5U 60U/person<br>|
| Experimental: Botulinum toxin type A(Hugeltox)<br>Botulinum toxin type A(Hugeltox) | Drug: Hugeltox<br>* 1.25U 2.5U/site, Maximum dosage 12.5U 60U/person<br>Drug: Botulinum Toxin Type A(Botox®)<br>* 1.25U 2.5U/site, Maximum dosage 12.5U 60U/person<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method) |  | at 4 weeks post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (1) Duration of action days |  | 6 months | 
| (2) Grades of Severity of Spasm (by Scott's Method), Functional Visual Status |  | at four weeks post-injection | 
| (3) Rate of patients with a Grade-0 or Grade-1 of Severity Spasm (by Scott's Method) |  | at four weeks post-injection | 
| (4) Rate of patients with an improvement more than two Grade of Severity of Spasm (by Scott's Method) |  | at four weeks post-injection |