<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/NCT03289702</url>
  </required_header>
  <id_info>
    <org_study_id>MT03-KR16MST907 (Phase3)</org_study_id>
    <nct_id>NCT03289702</nct_id>
  </id_info>
  <brief_title>CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase3)</brief_title>
  <official_title>A Randomized, Double-blind, Active Drug Controlled, Multi-Center, Phase I/III Clinical Trial to Evaluate the Efficacy and Safety of CORETOX® in Treatment of Post Stroke Upper Limb Spasticity</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>
      The purpose of this study is to evaluate the efficacy and safety of CORETOX® in the treatment&#xD;
      of post-stroke upper limb spasticity&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Actual">November 9, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MAS(Modified Ashworth Scale)of wrist flexor</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MAS(modified Ashworth Score)of elbow and finger flexor</measure>
    <time_frame>4 weeks after injection</time_frame>
    <description>Change from baseline at week 4 for elbow flexor and finger flexor muscle tone as measured on MAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MAS(modified Ashworth Score)of wrist, elbow and finger flexor</measure>
    <time_frame>8, 12 weeks after injection</time_frame>
    <description>Change from baseline at week 8, 12 for wrist flexor, elbow flexor and finger flexor muscle tone as measured on MAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of treatment responder at week 4, 8, 12 after injection</measure>
    <time_frame>4, 8, 12 weeks after injection</time_frame>
    <description>A treatment response is defined as 1-point improvement on the MAS of injection site</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Muscle Spasticity</condition>
  <arm_group>
    <arm_group_label>CORETOX®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BOTOX®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CORETOX®</intervention_name>
    <description>Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.</description>
    <arm_group_label>CORETOX®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BOTOX®</intervention_name>
    <description>Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.</description>
    <arm_group_label>BOTOX®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients ≥ 19 years&#xD;
&#xD;
          -  ≥ 6 months since the last stroke&#xD;
&#xD;
          -  ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of elbow&#xD;
             flexor and finger flexor as measured on MAS(0 to 4)&#xD;
&#xD;
          -  Informed consent has been obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or&#xD;
             amyotrophic lateral sclerosis&#xD;
&#xD;
          -  History(within 4 months of screening visit) or planned(during study period) treatment&#xD;
             with phenol or alcohol injection or surgery in the target limb&#xD;
&#xD;
          -  History(within 4 months of screening visit) or planned(during study period) treatment&#xD;
             with tendon lengthening in the target limb&#xD;
&#xD;
          -  Fixed joint/muscle contracture&#xD;
&#xD;
          -  Severe atrophy&#xD;
&#xD;
          -  Concurrent treatment with an intrathecal baclofen&#xD;
&#xD;
          -  Patients who have bleeding tendency or taking anti-coagulant&#xD;
&#xD;
          -  Dysphagia and Breathing Difficulties&#xD;
&#xD;
          -  History(within 4 months of screening visit) Planned(during study period) treatment&#xD;
             with Botulinum Toxin&#xD;
&#xD;
          -  Known allergy or sensitivity to study medication or its components&#xD;
&#xD;
          -  Concurrent or planed Muscle relaxants and/or benzodiazepine medication If patient has&#xD;
             taken these medication stable from one month before screening and no treatment changes&#xD;
             are not planned during the study, participation is allowed.&#xD;
&#xD;
          -  Current Physical, occupational, Splinting therapy These therapy regimens will be&#xD;
             permitted if they have been stable in the one month before screening; no treatment and&#xD;
             no changes are planned during the study.&#xD;
&#xD;
          -  Patient who are participating in other clinical trials at the screening&#xD;
&#xD;
          -  Females who are pregnant, breastfeeding, or planning a pregnancy during the study&#xD;
             period, or female of childbearing potential, not using a reliable means of&#xD;
             contraception.&#xD;
&#xD;
          -  Patients who are not eligible for this study at the discretion of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</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>December 2021</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>December 5, 2021</last_update_submitted>
  <last_update_submitted_qc>December 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2021</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>Muscle Spasticity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03289702
org study id: MT03-KR16MST907 (Phase3)
nct id: NCT03289702
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of CORETOX® in the treatment
      of post-stroke upper limb spasticity
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: MAS(Modified Ashworth Scale)of wrist flexor
time frame: 4 weeks
description: Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale)
measure: MAS(modified Ashworth Score)of elbow and finger flexor
time frame: 4 weeks after injection
description: Change from baseline at week 4 for elbow flexor and finger flexor muscle tone as measured on MAS
measure: MAS(modified Ashworth Score)of wrist, elbow and finger flexor
time frame: 8, 12 weeks after injection
description: Change from baseline at week 8, 12 for wrist flexor, elbow flexor and finger flexor muscle tone as measured on MAS
measure: Percentage of treatment responder at week 4, 8, 12 after injection
time frame: 4, 8, 12 weeks after injection
description: A treatment response is defined as 1-point improvement on the MAS of injection site
arm group label: CORETOX®
arm group type: Experimental
arm group label: BOTOX®
arm group type: Active Comparator
intervention type: Drug
intervention name: CORETOX®
description: Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.
arm group label: CORETOX®
intervention type: Drug
intervention name: BOTOX®
description: Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.
arm group label: BOTOX®
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Muscle Spasticity
sharing ipd: Undecided