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Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm

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ClinicalTrials.gov Identifier: NCT02947815
Recruitment Status : Completed
First Posted : October 28, 2016
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

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

Condition or disease Intervention/treatment Phase
Blepharospasm Drug: Clostridium Botulinum Toxin Type A Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018


Arm Intervention/treatment
Experimental: NABOTA
Single-dose
Drug: Clostridium Botulinum Toxin Type A
Other Name: NABOTA

Active Comparator: BOTOX
Single-dose
Drug: Clostridium Botulinum Toxin Type A
Other Name: BOTOX




Primary Outcome Measures :
  1. The change from baseline in Scott's Scale Score [ Time Frame: At 4 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947815


Locations
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Korea, Republic of
the catholic university of korea, Seoul ST. Mary's Hospital.
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.

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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT02947815     History of Changes
Other Study ID Numbers: DW_DWP450007
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Blepharospasm
Eyelid Diseases
Eye Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents