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

Hugel172 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

172

Conditions

Essential Blepharospasm

Interventions

HugeltoxDRUG

1.25U\~2.5U/site, Maximum dosage 12.5U\~60U/person

Botulinum Toxin Type A(Botox®)DRUG

1.25U\~2.5U/site, Maximum dosage 12.5U\~60U/person

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (9)

Samsung medical Center

Seoul, Seoul, South Korea

The Catholic University, Seoul, St.Mary's hospital

Seoul, Seoul, South Korea

Cha Hospital

Bundang, South Korea

Seoul National University Hospital - Bundang

Bundang, South Korea

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

Time frame: 6 months

(2) Grades of Severity of Spasm (by Scott's Method), Functional Visual Status

Time frame: at four weeks post-injection

(3) Rate of patients with a Grade-0 or Grade-1 of Severity Spasm (by Scott's Method)

Time frame: at four weeks post-injection

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

Time frame: at four weeks post-injection

Data from ClinicalTrials.gov

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