Efficacy and Safety Study of Meditoxin® to Treat Essentia... | NCT01259557

Studies
Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm

NCT01259557

Sponsor

Medy-Tox

Status

Completed

Last Update Posted

Apr 25, 2012Estimated

Enrollment

110Actual

Phase

Phase 4

Conditions

Essential Blepharospasm

Interventions

Botulinum Toxin Type A

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

May 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Nov 25, 2010

First Submission Date that Met QC Criteria

Dec 12, 2010

First Posted Date

Dec 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2012

Last Update Posted Date

Apr 25, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Botulinum toxin type A(Meditoxin®)	Experimental		Drug: Botulinum Toxin Type A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinum Toxin Type A	Drug	2 times, Intra-muscular injection, Maximum dosage total 60U	Botulinum toxin type A(Meditoxin®)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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)
the change rate of Blepharospasm Disability Index

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaechan Kim, M.D., Ph.D.	Chung-Ang university Yongsan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sevrance Hospital		Seoul		120-752	South Korea
Seoul St.Mary Hospital

Condition Browse Module

MeSH Terms

ID	Term
C535428	Benign essential blepharospasm

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided