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

Phase 2

Completed

• Conditions: Noise-induced Hearing Loss
• Interventions: Drug: Placebo; Drug: EPI-743

• Registration Number: NCT02257983
• Lead Sponsor: Edison Pharmaceuticals Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-11
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-07
• Study Start: 2014-10-31
• Primary Completion: 2015-11-30
• Study Completion: 2016-02-29
• Disposition First Submitted: 2020-08-17
• Disposition First Submitted QC: 2020-08-24
• Disposition First Posted: 2020-08-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Sesame Oil, NF in sealed gelatin capsules to match the test product
EPI-743	EPI-743	EPI-743 400 mg P.O. TID

Primary Outcome Measures

Name	Time	Method
Pure tone audiometry	9 days

Secondary Outcome Measures

Name	Time	Method
Time to recovery following acute noise exposure	9 days

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States