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Protective Effects of EPI-743 on Noise-Induced Hearing Loss

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ClinicalTrials.gov Identifier: NCT02257983
Recruitment Status : Completed
First Posted : October 7, 2014
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Edison Pharmaceuticals Inc

Tracking Information
First Submitted Date  ICMJE August 11, 2014
First Posted Date  ICMJE October 7, 2014
Last Update Posted Date November 18, 2020
Actual Study Start Date  ICMJE October 31, 2014
Actual Primary Completion Date November 30, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2014)
Pure tone audiometry [ Time Frame: 9 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2014)
Time to recovery following acute noise exposure [ Time Frame: 9 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protective Effects of EPI-743 on Noise-Induced Hearing Loss
Official Title  ICMJE A Phase 2A Randomized, Placebo Controlled, Double Blind Study of the Protective Effects of EPI-743 (VincerinoneTM) on Noise-Induced Hearing Loss
Brief Summary If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Noise-induced Hearing Loss
Intervention  ICMJE
  • Drug: EPI-743
    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.
    Other Names:
    • VincerinoneTM
    • EPI743
  • Drug: Placebo
    2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.
    Other Name: Matching placebo
Study Arms  ICMJE
  • Active Comparator: EPI-743
    EPI-743 400 mg P.O. TID
    Intervention: Drug: EPI-743
  • Placebo Comparator: Placebo
    Sesame Oil, NF in sealed gelatin capsules to match the test product
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2016)
77
Original Estimated Enrollment  ICMJE
 (submitted: October 6, 2014)
70
Actual Study Completion Date  ICMJE February 29, 2016
Actual Primary Completion Date November 30, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adults ages 18-30
  • Abstention from use of Idebenone, CoQ10, Vitamin E and foods or beverages at least 30 days prior to treatment initiation
  • Non-smokers
  • Abstention from alcohol from day 0 and throughout the duration of study
  • Normal audiology exam
  • Subject must be able to swallow size 0 capsules

Exclusion Criteria:

  • Allergy to EPI-743 or sesame oil or nuts
  • Any medical disordere that would prevent subject participation
  • Any prescription meds other than for contraception or seasonal allergies
  • Any significant patient medical history (cancer, cardiovascular, pulmonary, cognitive, ADHD, hx. of migraines, neurological, kidney)
  • Fat malabsorption syndromes
  • Anticoagulation thereapy within 30 days of enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02257983
Other Study ID Numbers  ICMJE EPI743-14-026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edison Pharmaceuticals Inc
Study Sponsor  ICMJE Edison Pharmaceuticals Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Colleen Le Prell, Ph.D University of Florida
PRS Account Edison Pharmaceuticals Inc
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP