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

Hugel9 sites in 1 country172 target enrollmentApril 2008

ConditionsEssential Blepharospasm

InterventionsHugeltox Botulinum Toxin Type A(Botox®)

DrugsHugeltox Botulinum Toxin Type A(Botox®)

Overview

Phase: Phase 3
Intervention: Hugeltox
Conditions: Essential Blepharospasm
Sponsor: Hugel
Enrollment: 172
Locations: 9
Primary Endpoint: Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method)
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

July 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hugel

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Botulinum toxin type A(Botox®)

Intervention: Hugeltox

Botulinum toxin type A(Botox®)

Intervention: Botulinum Toxin Type A(Botox®)

Botulinum toxin type A(Hugeltox)

Intervention: Hugeltox

Botulinum toxin type A(Hugeltox)

Intervention: Botulinum Toxin Type A(Botox®)

Outcomes

Primary Outcomes

Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method)

Time Frame: at 4 weeks post-injection

Secondary Outcomes

(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)