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

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

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

NCT01791881•Hugel

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

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

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

Youngnam University Hospital

Daegu, South Korea

Chungang University Hospital

Seoul, South Korea

Kim's eye hospital

Seoul, South Korea

The catholic university, Yeouido, St. Mary's hospital

Seoul, South Korea

Yeonsei University, Severance hospital - Gangnam

Seoul, South Korea

Key Dates

Start Date

April 1, 2008

Primary Completion Date

May 1, 2009

Completion Date

July 1, 2009

Last Updated

February 15, 2013

Enrollment

172

ACTUAL participants

Conditions

Essential Blepharospasm

Interventions

Hugeltox

DRUG

Botulinum Toxin Type A(Botox®)

DRUG

Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm

NCT01259557

Essential Blepharospasm

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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