Status:
COMPLETED
Protective Effects of EPI-743 on Noise-Induced Hearing Loss
Lead Sponsor:
Edison Pharmaceuticals Inc
Conditions:
Noise-induced Hearing Loss
Eligibility:
All Genders
18-30 years
Phase:
PHASE2
Brief Summary
If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2016
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT02257983
Start Date
October 31 2014
End Date
February 29 2016
Last Update
November 18 2020
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610