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 |
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.
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
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