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

NCT02257983 — Phase 2, Completed, 77 participants, Edison Pharmaceuticals Inc

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

Registry	NCT02257983
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	77 (Actual)
Sponsor	Edison Pharmaceuticals Inc (Industry)
Conditions	Noise-induced Hearing Loss
Interventions	EPI-743, Placebo (Drug)
Dates	start 2014-10-31, primary completion 2015-11-30, completion 2016-02-29, first posted 2014-10-07, last updated 2020-11-18
Locations	1 site in United States

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
EPI-743	Active comparator	Drug: EPI-743	EPI-743 400 mg P.O. TID
Placebo	Placebo comparator	Drug: Placebo	Sesame Oil, NF in sealed gelatin capsules to match the test product

EPI-743 (Drug), also known as VincerinoneTM, EPI743: 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 (Drug), also known as Matching placebo: 2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.

+Outcome measures

Primary outcomes

Pure tone audiometry [9 days]

Secondary outcomes

Time to recovery following acute noise exposure [9 days]

+Eligibility

Sex: All, ages: 18 Years to 30 Years, 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

+Locations (1)

Facility	City	Country	Status
University of Florida	Gainesville, Florida	United States

+Investigators

Colleen Le Prell, Ph.D, Principal investigator, University of Florida

My Notes

Public

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