Safety and Efficacy of NABOTA in Treatment of Essential B... | NCT02947815

Studies
Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm

NCT02947815

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Completed

Last Update Posted

Jun 26, 2019Actual

Enrollment

234Estimated

Phase

Phase 2Phase 3

Conditions

Blepharospasm

Interventions

Clostridium Botulinum Toxin Type A
Clostridium 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

Jun 2019

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

Oct 2016Actual

Primary Completion Date

Jan 2018Actual

Completion Date

Jan 2018Actual

First Submitted Date

Oct 24, 2016

First Submission Date that Met QC Criteria

Oct 26, 2016

First Posted Date

Oct 28, 2016Estimated

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

Jun 25, 2019

Last Update Posted Date

Jun 26, 2019Actual

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 NABOTA in 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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

234Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NABOTA	Experimental	Single-dose	Drug: Clostridium Botulinum Toxin Type A
BOTOX	Active Comparator	Single-dose	Drug: Clostridium Botulinum Toxin Type A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clostridium Botulinum Toxin Type A	Drug		NABOTA	NABOTA
Clostridium Botulinum Toxin Type A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change from baseline in Scott's Scale Score		At 4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male of female of at least 18 years old
Grade 2~4 in Scott's scale

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the catholic university of korea, Seoul ST. Mary's Hospital.		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001764	Blepharospasm

Ancestor Terms

ID	Term
D005141	Eyelid Diseases
D005128	Eye Diseases

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