Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Hugeltox

+ Botulinum Toxin Type A(Botox®)

+ Hugeltox

Drug
Who is being recruted

From 18 to 75 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 2008
See protocol details

Summary

Principal SponsorHugel
Last updated: February 15, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2008

Actual date on which the first participant was enrolled.

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

NCT01791881
Principal SponsorHugel
Last updated: February 15, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

172 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
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)
8 exclusion criteria prevent from participating
Patients have undergone surgical surgery to treat blepharospmasm like myectomy or neurectomy
Patients with any other significant neuromuscular disease like Myasthenia gravis
Patients with hemifacialspasm
Patients with hypersensitivity history to botulinum toxin products previously
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Botulinum toxin type A(Botox®)

Group II

Experimental
Botulinum toxin type A(Hugeltox)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Samsung medical Center

Seoul, South KoreaOpen Samsung medical Center in Google Maps

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

Seoul, South Korea

Cha Hospital

Bundang, South Korea

Seoul National University Hospital - Bundang

Bundang, South Korea
Completed9 Study Centers