<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/NCT02257983</url>
  </required_header>
  <id_info>
    <org_study_id>EPI743-14-026</org_study_id>
    <nct_id>NCT02257983</nct_id>
  </id_info>
  <brief_title>Protective Effects of EPI-743 on Noise-Induced Hearing Loss</brief_title>
  <official_title>A Phase 2A Randomized, Placebo Controlled, Double Blind Study of the Protective Effects of EPI-743 (VincerinoneTM) on Noise-Induced Hearing Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edison Pharmaceuticals Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Edison Pharmaceuticals Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      If effective, administration of EPI-743 should have protective effects against temporary&#xD;
      noise-induced hearing loss.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2014</start_date>
  <completion_date type="Actual">February 29, 2016</completion_date>
  <primary_completion_date type="Actual">November 30, 2015</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pure tone audiometry</measure>
    <time_frame>9 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to recovery following acute noise exposure</measure>
    <time_frame>9 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Noise-induced Hearing Loss</condition>
  <arm_group>
    <arm_group_label>EPI-743</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>EPI-743 400 mg P.O. TID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sesame Oil, NF in sealed gelatin capsules to match the test product</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EPI-743</intervention_name>
    <description>EPI-743 (2 capsules 200 mg each) taken at a dose of 400 mg P.O. TID for 9 days with noise exposure for 4 hours on Day 8.</description>
    <arm_group_label>EPI-743</arm_group_label>
    <other_name>VincerinoneTM</other_name>
    <other_name>EPI743</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Matching placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults ages 18-30&#xD;
&#xD;
          -  Abstention from use of Idebenone, CoQ10, Vitamin E and foods or beverages at least 30&#xD;
             days prior to treatment initiation&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Abstention from alcohol from day 0 and throughout the duration of study&#xD;
&#xD;
          -  Normal audiology exam&#xD;
&#xD;
          -  Subject must be able to swallow size 0 capsules&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to EPI-743 or sesame oil or nuts&#xD;
&#xD;
          -  Any medical disordere that would prevent subject participation&#xD;
&#xD;
          -  Any prescription meds other than for contraception or seasonal allergies&#xD;
&#xD;
          -  Any significant patient medical history (cancer, cardiovascular, pulmonary, cognitive,&#xD;
             ADHD, hx. of migraines, neurological, kidney)&#xD;
&#xD;
          -  Fat malabsorption syndromes&#xD;
&#xD;
          -  Anticoagulation thereapy within 30 days of enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Colleen Le Prell, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.edisonpharma.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <disposition_first_submitted>August 17, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>August 24, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 31, 2020</disposition_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hearing</keyword>
  <keyword>noise</keyword>
  <keyword>oxidative stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Hearing Loss, Noise-Induced</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ubiquinone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02257983
org study id: EPI743-14-026
nct id: NCT02257983
lead sponsor: 
has dmc: No
If effective, administration of EPI-743 should have protective effects against temporary
      noise-induced hearing loss.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pure tone audiometry
time frame: 9 days
measure: Time to recovery following acute noise exposure
time frame: 9 days
arm group label: EPI-743
arm group type: Active Comparator
description: EPI-743 400 mg P.O. TID
arm group label: Placebo
arm group type: Placebo Comparator
description: Sesame Oil, NF in sealed gelatin capsules to match the test product
intervention type: Drug
intervention name: EPI-743
description: EPI-743 (2 capsules 200 mg each) taken at a dose of 400 mg P.O. TID for 9 days with noise exposure for 4 hours on Day 8.
arm group label: EPI-743
other name: VincerinoneTM
other name: EPI743
intervention type: Drug
intervention name: Placebo
description: 2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.
arm group label: Placebo
other name: Matching placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Colleen Le Prell, Ph.D
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
url: http://www.edisonpharma.com
description: Related Info
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Noise-Induced
mesh term: Ubiquinone