Protective Effects of EPI-743 on Noise-Induced Hearing Loss | NCT02257983

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

NCT02257983

Sponsor

Edison Pharmaceuticals Inc

Status

Completed

Last Update Posted

Nov 18, 2020Actual

Enrollment

77Actual

Phase

Phase 2

Conditions

Noise-induced Hearing Loss

Interventions

EPI-743
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2014Actual

Primary Completion Date

Nov 30, 2015Actual

Completion Date

Feb 29, 2016Actual

First Submitted Date

Aug 11, 2014

First Submission Date that Met QC Criteria

Oct 6, 2014

First Posted Date

Oct 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Aug 17, 2020

Certification/Extension First Submitted that Passed QC Review

Aug 24, 2020

Certification/Extension First Posted Date

Aug 31, 2020Actual

Last Update Submitted Date

Nov 16, 2020

Last Update Posted Date

Nov 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	EPI-743

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pure tone audiometry		9 days

Secondary Outcomes

Measure	Description	Time Frame
Time to recovery following acute noise exposure		9 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Colleen Le Prell, Ph.D	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida		Gainesville	Florida	32610	United States

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D006317	Hearing Loss, Noise-Induced

Ancestor Terms

ID	Term
D006319	Hearing Loss, Sensorineural
D034381	Hearing Loss
D006311	Hearing Disorders
D004427	Ear Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C571746	alpha-tocotrienol quinone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided