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

February 13, 2013 updated by: Hugel

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bundang, Korea, Republic of
        • Cha Hospital
      • Bundang, Korea, Republic of
        • Seoul National University Hospital - Bundang
      • Daegu, Korea, Republic of
        • Youngnam University Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Chungang University Hospital
      • Seoul, Korea, Republic of
        • Kim's Eye Hospital
      • Seoul, Korea, Republic of
        • The Catholic University, Seoul, St.Mary's hospital
      • Seoul, Korea, Republic of
        • The catholic university, Yeouido, St. Mary's hospital
      • Seoul, Korea, Republic of
        • Yeonsei University, Severance hospital - Gangnam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Botulinum toxin type A(Botox®)
Drug: Hugeltox
1.25U~2.5U/site, Maximum dosage 12.5U~60U/person
Drug: Botulinum Toxin Type A(Botox®)
1.25U~2.5U/site, Maximum dosage 12.5U~60U/person
Experimental: Botulinum toxin type A(Hugeltox)
Drug: Hugeltox
1.25U~2.5U/site, Maximum dosage 12.5U~60U/person
Drug: Botulinum Toxin Type A(Botox®)
1.25U~2.5U/site, Maximum dosage 12.5U~60U/person

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at 4 weeks post-injection

Secondary Outcome Measures

Outcome Measure
Time Frame
(1) Duration of action days
Time Frame: 6 months
6 months
(2) Grades of Severity of Spasm (by Scott's Method), Functional Visual Status
Time Frame: at four weeks post-injection
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
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
at four weeks post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hugel

Investigators

  • Study Chair: Yoon-Duck Kim, M.D., Ph.D., Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 13, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 13, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HG-06-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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