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Efficacy and Safety of MEDITOXIN® in Cervical Dystonia (CD Phase III)

Primary Purpose

Cervical Dystonia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Medytoxin
Botox
Sponsored by
Medy-Tox
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Dystonia focused on measuring CD phase III

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women aged between 20 and 75.
  • Patient who is diagnosed with primary cervical dystonia over 1 year.
  • Patients whose total score is over 20 in TWSTRS and the severity score is over 10 in TWSTRS.
  • For patients with prior treatments of Botox®, over 12 weeks have passed.
  • Patients who voluntarily sign the informed consent
  • Patients who can comply with the study procedures and visit schedule

Exclusion Criteria:

  • Patient who has been diagnosed with pure anterocollis.
  • Patient who has been diagnosed with neuromuscular disorder(myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.)\
  • Severe respiratory function disorder or dysphasia
  • Allergy in Investigational Product.
  • Pregnant women, breast feeding women and patients disagreeing to use an acceptable contraception method
  • Investigator's decision.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Meditoxin

    Botox

    Arm Description

    Meditoxin administered 200U~300U, single-dose administration.

    Botox administered 200-300U, single-dose administration.

    Outcomes

    Primary Outcome Measures

    Change in TWSTRS score
    Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score after 1 month of administration. The scale consists scores from 0 to 35 which corresponds to disorder severity, 35 being the most severe.

    Secondary Outcome Measures

    Safety Analysis of Investigational Product: Number of adverse events occuring during the clinical trial
    Number of adverse events occuring during the clinical trial.
    Change in TWSTRS score
    Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score after 1, 2, and 3 month of administration. The scale consists scores from 0 to 35 which corresponds to disorder severity, 35 being the most severe.

    Full Information

    First Posted
    March 27, 2019
    Last Updated
    April 5, 2019
    Sponsor
    Medy-Tox
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03905304
    Brief Title
    Efficacy and Safety of MEDITOXIN® in Cervical Dystonia
    Acronym
    CD Phase III
    Official Title
    A Prospective, Randomized, Multi-center, Phase III, Double-Blind, Activi Controlled, Parallel-group Study to Evaliate the Efficacy and Safety of MEDITOXIN® Comparison With BOTOX® in Treatment of Cervical Dystonia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 9, 2013 (Actual)
    Primary Completion Date
    July 30, 2014 (Actual)
    Study Completion Date
    August 5, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medy-Tox

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of Cervical Dystonia.
    Detailed Description
    The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 200~300U in cervical muscles. The efficacy and safety are evaluated for 12weeks through 4 follow up visits.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Dystonia
    Keywords
    CD phase III

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    152 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Meditoxin
    Arm Type
    Experimental
    Arm Description
    Meditoxin administered 200U~300U, single-dose administration.
    Arm Title
    Botox
    Arm Type
    Active Comparator
    Arm Description
    Botox administered 200-300U, single-dose administration.
    Intervention Type
    Biological
    Intervention Name(s)
    Medytoxin
    Other Intervention Name(s)
    botulinum type A toxin
    Intervention Description
    Intramuscular injection up to 300U.
    Intervention Type
    Biological
    Intervention Name(s)
    Botox
    Other Intervention Name(s)
    botulinum type A toxin
    Intervention Description
    Intramuscular injection up to 300U.
    Primary Outcome Measure Information:
    Title
    Change in TWSTRS score
    Description
    Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score after 1 month of administration. The scale consists scores from 0 to 35 which corresponds to disorder severity, 35 being the most severe.
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Safety Analysis of Investigational Product: Number of adverse events occuring during the clinical trial
    Description
    Number of adverse events occuring during the clinical trial.
    Time Frame
    1, 2, 3 months
    Title
    Change in TWSTRS score
    Description
    Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score after 1, 2, and 3 month of administration. The scale consists scores from 0 to 35 which corresponds to disorder severity, 35 being the most severe.
    Time Frame
    1, 2, 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men and women aged between 20 and 75. Patient who is diagnosed with primary cervical dystonia over 1 year. Patients whose total score is over 20 in TWSTRS and the severity score is over 10 in TWSTRS. For patients with prior treatments of Botox®, over 12 weeks have passed. Patients who voluntarily sign the informed consent Patients who can comply with the study procedures and visit schedule Exclusion Criteria: Patient who has been diagnosed with pure anterocollis. Patient who has been diagnosed with neuromuscular disorder(myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.)\ Severe respiratory function disorder or dysphasia Allergy in Investigational Product. Pregnant women, breast feeding women and patients disagreeing to use an acceptable contraception method Investigator's decision.

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of MEDITOXIN® in Cervical Dystonia

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