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

Noise-induced Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02257983
• Other study ID #: EPI743-14-026
• Status: Completed
• Phase: Phase 2
• Start date: October 31, 2014
• Est. completion date: February 29, 2016

Study information

• Verified date: November 2020
• Source: Edison Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: February 29, 2016
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Noise-Induced
• Noise-induced Hearing Loss

Intervention

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

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Edison Pharmaceuticals Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pure tone audiometry		9 days
Secondary	Time to recovery following acute noise exposure		9 days

External Links

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