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Completed

NCT Number: NCT02257983

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

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

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Key information

Conditions

Noise-induced Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Noise-Induced Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPI-743

Drug

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.

Other names: VincerinoneTM, EPI743

Placebo

Drug

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

Other names: Matching placebo

Primary outcomes

  1. Pure tone audiometry

    Time frame: 9 days

Secondary outcomes

  1. Time to recovery following acute noise exposure

    Time frame: 9 days

Sponsors and collaborators

Lead sponsor

Edison Pharmaceuticals Inc

Industry

Registry information

Official study title

A Phase 2A Randomized, Placebo Controlled, Double Blind Study of the Protective Effects of EPI-743 (VincerinoneTM) on Noise-Induced Hearing Loss

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 7, 2014
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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