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

Phase 3

Completed

• Conditions: Essential Blepharospasm
• Interventions: Drug: Hugeltox; Drug: Botulinum Toxin Type A(Botox®)

• Registration Number: NCT01791881
• Lead Sponsor: Hugel

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2009-05
• Study Completion: 2009-07
• Status Verified: 2013-02
• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-13
• Last Update Submitted: 2013-02-13
• Study First Posted: 2013-02-15
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin type A(Hugeltox)	Hugeltox	Botulinum toxin type A(Hugeltox)
Botulinum toxin type A(Hugeltox)	Botulinum Toxin Type A(Botox®)	Botulinum toxin type A(Hugeltox)
Botulinum toxin type A(Botox®)	Hugeltox	Botulinum toxin type A(Botox®)
Botulinum toxin type A(Botox®)	Botulinum Toxin Type A(Botox®)	Botulinum toxin type A(Botox®)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
(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

Trial Locations

Locations (9)

Cha Hospital; 🇰🇷 Bundang, Korea, Republic of

Seoul National University Hospital - Bundang; 🇰🇷 Bundang, Korea, Republic of

Youngnam University Hospital; 🇰🇷 Daegu, Korea, Republic of

Chungang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Kim's eye hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung medical Center; 🇰🇷 Seoul, Korea, Republic of

Yeonsei University, Severance hospital - Gangnam; 🇰🇷 Seoul, Korea, Republic of

The catholic university, Yeouido, St. Mary's hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic University, Seoul, St.Mary's hospital; 🇰🇷 Seoul, Korea, Republic of