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

Phase 2CompletedNCT02257983

Edison Pharmaceuticals Inc77 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Noise-induced Hearing Loss

Interventions

EPI-743DRUG

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.

PlaceboDRUG

2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Pure tone audiometry

Time frame: 9 days

Secondary Outcomes

Time to recovery following acute noise exposure

Time frame: 9 days

Data from ClinicalTrials.gov

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