Protective Effects of EPI-743 on Noise-Induced Hearing Loss
Primary Purpose
Noise-induced Hearing Loss
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EPI-743
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Noise-induced Hearing Loss focused on measuring hearing, noise, oxidative stress
Eligibility Criteria
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
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
EPI-743
Placebo
Arm Description
EPI-743 400 mg P.O. TID
Sesame Oil, NF in sealed gelatin capsules to match the test product
Outcomes
Primary Outcome Measures
Pure tone audiometry
Secondary Outcome Measures
Time to recovery following acute noise exposure
Full Information
NCT ID
NCT02257983
First Posted
August 11, 2014
Last Updated
November 16, 2020
Sponsor
Edison Pharmaceuticals Inc
1. Study Identification
Unique Protocol Identification Number
NCT02257983
Brief Title
Protective Effects of EPI-743 on Noise-Induced Hearing Loss
Official Title
A Phase 2A Randomized, Placebo Controlled, Double Blind Study of the Protective Effects of EPI-743 (VincerinoneTM) on Noise-Induced Hearing Loss
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 31, 2014 (Actual)
Primary Completion Date
November 30, 2015 (Actual)
Study Completion Date
February 29, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edison Pharmaceuticals Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noise-induced Hearing Loss
Keywords
hearing, noise, oxidative stress
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EPI-743
Arm Type
Active Comparator
Arm Description
EPI-743 400 mg P.O. TID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sesame Oil, NF in sealed gelatin capsules to match the test product
Intervention Type
Drug
Intervention Name(s)
EPI-743
Other Intervention Name(s)
VincerinoneTM, EPI743
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching placebo
Intervention Description
2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.
Primary Outcome Measure Information:
Title
Pure tone audiometry
Time Frame
9 days
Secondary Outcome Measure Information:
Title
Time to recovery following acute noise exposure
Time Frame
9 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Le Prell, Ph.D
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.edisonpharma.com
Description
Related Info
Learn more about this trial
Protective Effects of EPI-743 on Noise-Induced Hearing Loss
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