<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/NCT03229031</url>
  </required_header>
  <id_info>
    <org_study_id>ES135-1601</org_study_id>
    <nct_id>NCT03229031</nct_id>
  </id_info>
  <brief_title>A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury</brief_title>
  <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eusol Biotech Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eusol Biotech Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To demonstrate the superior effect of ES135 combined with spinal cord repairing surgery,&#xD;
      compared to a placebo control with spinal cord repairing surgery, on post-surgery motor&#xD;
      function recovery as measured by the changes from baseline of ISNCSCI Motor Scores in&#xD;
      subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    low recruitment rate&#xD;
  </why_stopped>
  <start_date type="Actual">March 7, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Randomized, Double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores</measure>
    <time_frame>48 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>ES135</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>ES135</intervention_name>
    <description>ES135 will be administered via intrathecal</description>
    <arm_group_label>ES135</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects of either sex and 15-65 years of age.&#xD;
&#xD;
          2. Subjects have spinal cord injury and the subjects must be categorized as Grade A or B&#xD;
             by the ASIA Impairment Scale.&#xD;
&#xD;
          3. Subjects have adequate heart, lung, kidney and liver function.&#xD;
&#xD;
          4. Subjects are able to give voluntary and dated informed consent prior to enrollment.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Penetration SCI&#xD;
&#xD;
          2. Brain damage or multiple injuries&#xD;
&#xD;
          3. History of congenital or acquired abnormalities in the spinal cavity&#xD;
&#xD;
          4. History of congenital or acquired immunodeficiency disorders&#xD;
&#xD;
          5. History of malignancies or positive results&#xD;
&#xD;
          6. Current serious/uncontrollable infections or others serious diseases&#xD;
&#xD;
          7. Pregnant or lactating women&#xD;
&#xD;
          8. Allergy to ES135 or any of its excipients&#xD;
&#xD;
          9. Unable to obtain informed consent from subject&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kaohsiung Veterans General Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>New Taipei City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>April 20, 2023</last_update_submitted>
  <last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>spinal cord, spinal cord injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_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/NCT03229031
org study id: ES135-1601
nct id: NCT03229031
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To demonstrate the superior effect of ES135 combined with spinal cord repairing surgery,
      compared to a placebo control with spinal cord repairing surgery, on post-surgery motor
      function recovery as measured by the changes from baseline of ISNCSCI Motor Scores in
      subjects
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Randomized, Double-blind
measure: Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores
time frame: 48 weeks
arm group label: ES135
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: ES135
description: ES135 will be administered via intrathecal
arm group label: ES135
arm group label: Placebo
criteria: 
gender: All
minimum age: 15 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries