Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm

April 24, 2012 updated by: Medy-Tox

Multi-center, Phase Ⅳ, Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Meditoxin® in Subjects With Essential Blepharospasm

The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of Essential blepharospasm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 4

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
      • Seoul, Korea, Republic of, 120-752
        • Sevrance Hospital
      • Seoul, Korea, Republic of, 137-040
        • Seoul St.Mary Hospital
      • Seoul, Korea, Republic of, 140-883
        • Chung-Ang Univesity Yongsan Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women aged above 18
  • Subjects who was diagnosed with Essential Blepharospasm
  • Subjects who voluntarily Signed written informed consent
  • Subjects who can adhere to protocol and study requirements

Exclusion Criteria:

  • Subjects with known history of allergy considered due to Botulinum toxin type A
  • Subjects who have received botulinum toxin A type within 3 months
  • Any disease that might affect neuromuscular function (e.g.. Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis ect.)
  • Subjects who are participating in other clinical trials
  • Pregnant or lactating female Subjects
  • Subjects who are not eligible for the study at the discretion of the Investigator.

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botulinum toxin type A(Meditoxin®)
Drug: Botulinum Toxin Type A
2 times, Intra-muscular injection, Maximum dosage total 60U
Other Names:
  • Meditoxin
  • Neuronox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change rate of Jankovic Rating Scale score
Time Frame: 4weeks
To evaluate the change of JRS(Jankovic Rating Scale) score at 4 weeks post treatment based on baseline( 0 week).
4weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change rate of Jankovic Rating Scale scale
Time Frame: 0 week, 16weeks(or retreatment point)
To evaluate the change of JRS(Jankovic Rating Scale) at retreatment point or 16 weeks post treatment based on Baseline(0 week).
0 week, 16weeks(or retreatment point)
the change rate of Blepharospasm Disability Index
Time Frame: 0week, 4weeks, 8weeks, 16weeks(or retreatment point)
To evaluate the change of Blepharospasm Disalbility Index at 4weeks, 8weeks, 16weeks(or retreatment point) post treatment.
0week, 4weeks, 8weeks, 16weeks(or retreatment point)
Global assessment about the improvement
Time Frame: 4weeks
To evaluate the Global assessment about the improvement at 4weeks post treatment.
4weeks
the duration of efficacy
Time Frame: retreatment point or 16 weeks
To evaluate the duration of efficacy
retreatment point or 16 weeks

Collaborators and Investigators

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

Sponsor

Medy-Tox

Investigators

  • Principal Investigator: Jaechan Kim, M.D., Ph.D., Chung-Ang university Yongsan Hospital

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

August 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

November 25, 2010

First Submitted That Met QC Criteria

December 12, 2010

First Posted (Estimate)

December 14, 2010

Study Record Updates

Last Update Posted (Estimate)

April 25, 2012

Last Update Submitted That Met QC Criteria

April 24, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-PRT-BP02

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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