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



Status:Completed
Conditions:Other Indications, Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 30
Updated:4/21/2016
Start Date:October 2014
End Date:February 2016

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A Phase 2A Randomized, Placebo Controlled, Double Blind Study of the Protective Effects of EPI-743 (VincerinoneTM) on Noise-Induced Hearing Loss

If effective, administration of EPI-743 should have protective effects against temporary
noise-induced hearing loss.


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
We found this trial at
1
site
205 Matherly hall
Gainsville, Florida 32611
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Gainsville, FL
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