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Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Completed
CT.gov ID
NCT02947815
Collaborator
(none)
234
Enrollment
1
Location
2
Arms
15
Actual Duration (Months)
15.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Clostridium Botulinum Toxin Type A
  • Drug: Clostridium Botulinum Toxin Type A
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 1, 2016
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
Jan 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: NABOTA

Single-dose

Drug: Clostridium Botulinum Toxin Type A
Other Names:
  • NABOTA

    		•
    Active Comparator: BOTOX

    Single-dose

    Drug: Clostridium Botulinum Toxin Type A
    Other Names:
  • BOTOX

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The change from baseline in Scott's Scale Score [At 4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male of female of at least 18 years old

    • Grade 2~4 in Scott's scale

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the catholic university of korea, Seoul ST. Mary's Hospital. Seoul Korea, Republic of

    Sponsors and Collaborators

    • Daewoong Pharmaceutical Co. LTD.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daewoong Pharmaceutical Co. LTD.
    ClinicalTrials.gov Identifier:
    NCT02947815
    Other Study ID Numbers:
    • DW_DWP450007
    First Posted:
    Oct 28, 2016
    Last Update Posted:
    Jun 26, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Blepharospasm
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Jun 26, 2019