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

Hugel

Status and phase: Completed; Phase 3

Conditions: Essential Blepharospasm

Treatments: Drug: Hugeltox; Drug: Botulinum Toxin Type A(Botox®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01791881

HG-06-01

Details and patient eligibility

About

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

Enrollment: 172 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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172 participants in 2 patient groups

Botulinum toxin type A(Botox®)

Active Comparator group

Description:

Botulinum toxin type A(Botox®)

Treatment:

Drug: Botulinum Toxin Type A(Botox®)

Drug: Hugeltox

Botulinum toxin type A(Hugeltox)

Experimental group

Description:

Botulinum toxin type A(Hugeltox)

Treatment:

Drug: Botulinum Toxin Type A(Botox®)

Drug: Hugeltox