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CompletedNCT02947815Updated Jun 26, 2019

Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm

A Phase 2/3 interventional study of Clostridium Botulinum Toxin Type A and Clostridium Botulinum Toxin Type A in Blepharospasm, sponsored by Daewoong Pharmaceutical Co. LTD.. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-26.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
234
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Blepharospasm

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03

In context

Blepharospasm

42 studies on the registry are indexed under Blepharospasm; 1 is open to participants now.

This study's planned enrollment of 234 is above the median of 40 across 28 interventional studies indexed under Blepharospasm.

Browse Blepharospasm studies →

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 200 studies on the registry; 33 are open to participants now.

Browse Daewoong Pharmaceutical Co. LTD. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Male of female of at least 18 years old
  • Grade 2\~4 in Scott's scale
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
234 participants (estimated)

Study arms

  • Experimental
    NABOTA

    Single-dose

    Drug: Clostridium Botulinum Toxin Type A

  • Active comparator
    BOTOX

    Single-dose

    Drug: Clostridium Botulinum Toxin Type A

Interventions

06

What researchers measure

Primary outcomes

  1. The change from baseline in Scott's Scale Score

    Time frame: At 4 weeks

07

Study locations

1 site
  • the catholic university of korea, Seoul ST. Mary's Hospital.
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2016 to primary completion in Jan 2018, 15 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2016
First posted
Oct 28, 2016
StartActual
Oct 2016
Primary completionActual
Jan 2018
CompletionActual
Jan 2018
Last update
Jun 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02947815
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Oct 28, 2016
Start date
Oct 2016
Primary completion
Jan 2018
Completion
Jan 2018
Last update
Jun 26, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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