Protective Effects of EPI-743 on Noise-Induced Hearing Loss
A Phase 2A Randomized, Placebo Controlled, Double Blind Study of the Protective Effects of EPI-743 (VincerinoneTM) on Noise-Induced Hearing Loss
1 other identifier
interventional
77
1 country
1
Brief Summary
If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2014
CompletedFirst Posted
Study publicly available on registry
October 7, 2014
CompletedStudy Start
First participant enrolled
October 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2016
CompletedNovember 18, 2020
November 1, 2020
1.1 years
August 11, 2014
November 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pure tone audiometry
9 days
Secondary Outcomes (1)
Time to recovery following acute noise exposure
9 days
Study Arms (2)
EPI-743
ACTIVE COMPARATOREPI-743 400 mg P.O. TID
Placebo
PLACEBO COMPARATORSesame Oil, NF in sealed gelatin capsules to match the test product
Interventions
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.
2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida
Gainesville, Florida, 32610, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Colleen Le Prell, Ph.D
University of Florida
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2014
First Posted
October 7, 2014
Study Start
October 31, 2014
Primary Completion
November 30, 2015
Study Completion
February 29, 2016
Last Updated
November 18, 2020
Record last verified: 2020-11