Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01259557

Enrollment

110

Registered

2010-12-14

Start date

2010-08-31

Completion date

2011-08-31

Last updated

2012-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Blepharospasm

Brief summary

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

Interventions

DRUGBotulinum Toxin Type A

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026