Noise-induced Hearing Loss
Conditions
Keywords
hearing, noise, oxidative stress
Brief summary
If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.
Interventions
DRUGEPI-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.
DRUGPlacebo
2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.
Sponsors
Edison Pharmaceuticals Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pure tone audiometry | 9 days |
Secondary
| Measure | Time frame |
|---|---|
| Time to recovery following acute noise exposure | 9 days |
Countries
United States
Outcome results
None listed