Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm

Phase 4

Completed

• Conditions: Essential Blepharospasm
• Interventions: Drug: Botulinum Toxin Type A

• Registration Number: NCT01259557
• Lead Sponsor: Medy-Tox

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-11-25
• Study First Submitted QC: 2010-12-12
• Study First Posted: 2010-12-14
• Primary Completion: 2011-05
• Study Completion: 2011-08
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-24
• Last Update Posted: 2012-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Botulinum toxin type A(Meditoxin®)	Botulinum Toxin Type A	-

Primary Outcome Measures

Name	Time	Method
the change rate of Jankovic Rating Scale score	4weeks	To evaluate the change of JRS(Jankovic Rating Scale) score at 4 weeks post treatment based on baseline( 0 week).

Secondary Outcome Measures

Name	Time	Method
the change rate of Jankovic Rating Scale scale	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).
the change rate of Blepharospasm Disability Index	0week, 4weeks, 8weeks, 16weeks(or retreatment point)	To evaluate the change of Blepharospasm Disalbility Index at 4weeks, 8weeks, 16weeks(or retreatment point) post treatment.
Global assessment about the improvement	4weeks	To evaluate the Global assessment about the improvement at 4weeks post treatment.
the duration of efficacy	retreatment point or 16 weeks	To evaluate the duration of efficacy

Trial Locations

Locations (3)

Sevrance Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul St.Mary Hospital; 🇰🇷 Seoul, Korea, Republic of

Chung-Ang Univesity Yongsan Hospital; 🇰🇷 Seoul, Korea, Republic of