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

Edison Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Noise-induced Hearing Loss

Treatments: Drug: EPI-743; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02257983

EPI743-14-026

Details and patient eligibility

About

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

Enrollment: 77 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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77 participants in 2 patient groups, including a placebo group

EPI-743

Active Comparator group

Description:

EPI-743 400 mg P.O. TID

Treatment:

Drug: EPI-743

Placebo

Placebo Comparator group

Description:

Sesame Oil, NF in sealed gelatin capsules to match the test product

Treatment:

Drug: Placebo