Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3; Phase 2

Conditions: Blepharospasm

Treatments: Drug: Clostridium Botulinum Toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02947815

DW_DWP450007

Details and patient eligibility

About

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

Enrollment: 234 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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234 participants in 2 patient groups

NABOTA

Experimental group

Description:

Single-dose

Treatment:

Drug: Clostridium Botulinum Toxin Type A

Drug: Clostridium Botulinum Toxin Type A

BOTOX

Active Comparator group

Description:

Single-dose

Treatment:

Drug: Clostridium Botulinum Toxin Type A

Drug: Clostridium Botulinum Toxin Type A