Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm

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Brief Title

Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm

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

Brief Summary

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


Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

The change from baseline in Scott's Scale Score


Condition

Blepharospasm

Intervention

Clostridium Botulinum Toxin Type A

Study Arms / Comparison Groups

 NABOTA
Description:  Single-dose

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

234

Start Date

October 2016

Completion Date

January 2018

Primary Completion Date

January 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Male of female of at least 18 years old

          -  Grade 2~4 in Scott's scale
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT02947815

Organization ID

DW_DWP450007


Responsible Party

Sponsor

Study Sponsor

Daewoong Pharmaceutical Co. LTD.


Study Sponsor

, , 


Verification Date

June 2019