Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm

Essential Blepharospasm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259557
• Other study ID #: MT-PRT-BP02
• Status: Completed
• Phase: Phase 4
• First received: November 25, 2010
• Last updated: April 24, 2012
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: April 2012
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharospasm
• Essential Blepharospasm

Intervention

Drug:
• Botulinum Toxin Type A
2 times, Intra-muscular injection, Maximum dosage total 60U

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang Univesity Yongsan Hospital	Seoul
Korea, Republic of	Seoul St.Mary Hospital	Seoul
Korea, Republic of	Sevrance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change rate of Jankovic Rating Scale score	To evaluate the change of JRS(Jankovic Rating Scale) score at 4 weeks post treatment based on baseline( 0 week).	4weeks	No
Secondary	the change rate of Jankovic Rating Scale scale	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)	No
Secondary	the change rate of Blepharospasm Disability Index	To evaluate the change of Blepharospasm Disalbility Index at 4weeks, 8weeks, 16weeks(or retreatment point) post treatment.	0week, 4weeks, 8weeks, 16weeks(or retreatment point)	No
Secondary	Global assessment about the improvement	To evaluate the Global assessment about the improvement at 4weeks post treatment.	4weeks	No
Secondary	the duration of efficacy	To evaluate the duration of efficacy	retreatment point or 16 weeks	No