Status:
COMPLETED
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm
Lead Sponsor:
Hugel
Conditions:
Essential Blepharospasm
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT01791881
Start Date
April 1 2008
End Date
July 1 2009
Last Update
February 15 2013
Active Locations (9)
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1
Samsung medical Center
Seoul, Seoul, South Korea
2
The Catholic University, Seoul, St.Mary's hospital
Seoul, Seoul, South Korea
3
Cha Hospital
Bundang, South Korea
4
Seoul National University Hospital - Bundang
Bundang, South Korea