NCT02947815

Brief Summary

The purpose of this study is to evaluate the Efficacy and Safety of NABOTA in treatment of essential blepharospasm

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

October 24, 2016

Last Update Submit

June 25, 2019

Conditions

Blepharospasm

Outcome Measures

Primary Outcomes (1)

  • The change from baseline in Scott's Scale Score

    At 4 weeks

Study Arms (2)

NABOTA

EXPERIMENTAL

Single-dose

Drug: Clostridium Botulinum Toxin Type A

BOTOX

ACTIVE COMPARATOR

Single-dose

Drug: Clostridium Botulinum Toxin Type A

Interventions

Clostridium Botulinum Toxin Type ADRUG
Also known as: NABOTA
NABOTA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the catholic university of korea, Seoul ST. Mary's Hospital.

Seoul, South Korea

Location

MeSH Terms

Conditions

Blepharospasm

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 28, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

June 26, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)