Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm

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

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Key information

Conditions

Blepharospasm Eye Diseases Eyelid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Clostridium Botulinum Toxin Type A

Drug

Other names: NABOTA

Primary outcomes

The change from baseline in Scott's Scale Score

Time frame: At 4 weeks

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Oct 28, 2016
Registry last updated: Jun 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed