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Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm

A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase II/III Clinical Trial to Compare the Safety and Efficacy of NABOTA Versus BOTOX in Treatment of Essential Blepharospasm

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02947815
Enrollment
234
Registered
2016-10-28
Start date
2016-10-31
Completion date
2018-01-31
Last updated
2019-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blepharospasm

Brief summary

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

Interventions

DRUGClostridium Botulinum Toxin Type A

Sponsors

Daewoong Pharmaceutical Co. LTD.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The change from baseline in Scott's Scale ScoreAt 4 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026