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

November 16, 2020 updated by: Edison Pharmaceuticals Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EPI-743
EPI-743 400 mg P.O. TID
Drug: EPI-743
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 Comparator: Placebo
Sesame Oil, NF in sealed gelatin capsules to match the test product
Drug: Placebo
2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.
Other Names:
  • Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pure tone audiometry
Time Frame: 9 days
9 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to recovery following acute noise exposure
Time Frame: 9 days
9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edison Pharmaceuticals Inc

Investigators

  • Principal Investigator: Colleen Le Prell, Ph.D, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2014

Primary Completion (Actual)

November 30, 2015

Study Completion (Actual)

February 29, 2016

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (Estimate)

October 7, 2014

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPI743-14-026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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