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Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm

This study has been completed.
Sponsor:
Information provided by:
Medy-Tox
ClinicalTrials.gov Identifier:
NCT01259557
First received: November 25, 2010
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Essential Blepharospasm
 Drug: Botulinum Toxin Type A
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center, Phase Ⅳ, Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Meditoxin® in Subjects With Essential Blepharospasm

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Medy-Tox:

Primary Outcome Measures:
  • the change rate of Jankovic Rating Scale score [ Time Frame: 4weeks ] [ Designated as safety issue: No ]
    To evaluate the change of JRS(Jankovic Rating Scale) score at 4 weeks post treatment based on baseline( 0 week).


Secondary Outcome Measures:
  • the change rate of Jankovic Rating Scale scale [ Time Frame: 0 week, 16weeks(or retreatment point) ] [ Designated as safety issue: No ]
    To evaluate the change of JRS(Jankovic Rating Scale) at retreatment point or 16 weeks post treatment based on Baseline(0 week).

  • the change rate of Blepharospasm Disability Index [ Time Frame: 0week, 4weeks, 8weeks, 16weeks(or retreatment point) ] [ Designated as safety issue: No ]
    To evaluate the change of Blepharospasm Disalbility Index at 4weeks, 8weeks, 16weeks(or retreatment point) post treatment.

  • Global assessment about the improvement [ Time Frame: 4weeks ] [ Designated as safety issue: No ]
    To evaluate the Global assessment about the improvement at 4weeks post treatment.

  • the duration of efficacy [ Time Frame: retreatment point or 16 weeks ] [ Designated as safety issue: No ]
    To evaluate the duration of efficacy


Enrollment: 110
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum toxin type A(Meditoxin®) Drug: Botulinum Toxin Type A
2 times, Intra-muscular injection, Maximum dosage total 60U
Other Names:
  • Meditoxin
  • Neuronox

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259557

Locations
Korea, Republic of
Chung-Ang Univesity Yongsan Hospital
Seoul, Korea, Republic of, 140-883
Seoul St.Mary Hospital
Seoul, Korea, Republic of, 137-040
Sevrance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Medy-Tox
Investigators
Principal Investigator: Jaechan Kim, M.D., Ph.D. Chung-Ang university Yongsan Hospital
  More Information

No publications provided

Responsible Party: Yujin Sun / CRA, Medytox
ClinicalTrials.gov Identifier: NCT01259557     History of Changes
Other Study ID Numbers: MT-PRT-BP02
Study First Received: November 25, 2010
Last Updated: April 24, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Blepharospasm
Eyelid Diseases
Eye Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013