<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03232320</url>
  </required_header>
  <id_info>
    <org_study_id>MT01-KR16CVD309</org_study_id>
    <nct_id>NCT03232320</nct_id>
  </id_info>
  <brief_title>Meditoxin® Treatment in Patients With Cervical Dystonia</brief_title>
  <official_title>A Prospective, Randomized, Multi-center, Phase III, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Cervical Dystonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medy-Tox</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medy-Tox</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared&#xD;
      with placebo (normal saline)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 6, 2017</start_date>
  <completion_date type="Actual">November 5, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline</measure>
    <time_frame>week 4 follow-up visit</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline</measure>
    <time_frame>week 4 follow-up visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline</measure>
    <time_frame>week 4 follow-up visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline</measure>
    <time_frame>week 4 follow-up visit</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Dystonia</condition>
  <condition>Dystonic Disorder</condition>
  <arm_group>
    <arm_group_label>MEDITOXIN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Meditoxin</intervention_name>
    <description>Meditoxin (Botulinum toxin type A)</description>
    <arm_group_label>MEDITOXIN</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo (Normal saline)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged 20 to less than 75 years&#xD;
&#xD;
          -  Subjects requiring treatment for a clinical diagnosis of cervical dystonia with&#xD;
             Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS)-Total Score &gt;=20 and&#xD;
             TWSTRS-Severity score &gt;=10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with pure anterocollis&#xD;
&#xD;
          -  Subjects with neuromuscular junctional disorders (e.g., myasthenia gravis,&#xD;
             Lambert-Eaton syndrome)&#xD;
&#xD;
          -  A history of an anaphylactic response to Botulinum toxin type A and other involved&#xD;
             ingredients of Investigational product&#xD;
&#xD;
          -  Subjects of reproductive age who do not agree to use suitable contraceptive methods&#xD;
             for the duration of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>March 25, 2019</last_update_submitted>
  <last_update_submitted_qc>March 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dystonia</mesh_term>
    <mesh_term>Dystonic Disorders</mesh_term>
    <mesh_term>Torticollis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03232320
org study id: MT01-KR16CVD309
nct id: NCT03232320
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared
      with placebo (normal saline)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
time frame: week 4 follow-up visit
measure: Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline
time frame: week 4 follow-up visit
measure: Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline
time frame: week 4 follow-up visit
measure: Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline
time frame: week 4 follow-up visit
arm group label: MEDITOXIN
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Meditoxin
description: Meditoxin (Botulinum toxin type A)
arm group label: MEDITOXIN
intervention type: Drug
intervention name: Placebo
description: Placebo (Normal saline)
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Dystonia
mesh term: Dystonic Disorders
mesh term: Torticollis
mesh term: Botulinum Toxins, Type A