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NCT02947815 Clinical Trial

Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm

Blepharospasm Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02947815
Other study ID # DW_DWP450007
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date October 2016
Est. completion date January 2018

Study information
Verified date June 2019
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 234
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male of female of at least 18 years old

- Grade 2~4 in Scott's scale

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Clostridium Botulinum Toxin Type A

• Clostridium Botulinum Toxin Type A

Locations
Country Name City State
Korea, Republic of the catholic university of korea, Seoul ST. Mary's Hospital. Seoul

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The change from baseline in Scott's Scale Score At 4 weeks
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