Noise-induced Hearing Loss Clinical Trial
Official title:
A Phase 2A Randomized, Placebo Controlled, Double Blind Study of the Protective Effects of EPI-743 (VincerinoneTM) on Noise-Induced Hearing Loss
Verified date | November 2020 |
Source | Edison Pharmaceuticals Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.
Status | Completed |
Enrollment | 77 |
Est. completion date | February 29, 2016 |
Est. primary completion date | November 30, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
Edison Pharmaceuticals Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pure tone audiometry | 9 days | ||
Secondary | Time to recovery following acute noise exposure | 9 days |
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