Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm

NCT ID: NCT02947815

Last Updated: 2019-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-01-31

Brief Summary

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

Detailed Description

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Conditions

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Blepharospasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NABOTA

Single-dose

Group Type EXPERIMENTAL

Clostridium Botulinum Toxin Type A

Intervention Type DRUG

BOTOX

Single-dose

Group Type ACTIVE_COMPARATOR

Clostridium Botulinum Toxin Type A

Intervention Type DRUG

Interventions

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Clostridium Botulinum Toxin Type A

Intervention Type DRUG

Clostridium Botulinum Toxin Type A

Intervention Type DRUG

Other Intervention Names

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NABOTA BOTOX

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_DWP450007

Identifier Type: -

Identifier Source: org_study_id

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