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Completed

NCT Number: NCT01259557

Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm

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

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Key information

Conditions

Essential Blepharospasm Benign essential blepharospasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chung-Ang Univesity Yongsan Hospital, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum Toxin Type A

Drug

2 times, Intra-muscular injection, Maximum dosage total 60U

Other names: Meditoxin, Neuronox

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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.

  3. Global assessment about the improvement

    Time frame: 4weeks

    To evaluate the Global assessment about the improvement at 4weeks post treatment.

  4. the duration of efficacy

    Time frame: retreatment point or 16 weeks

    To evaluate the duration of efficacy

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 14, 2010
Registry last updated
Apr 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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