Noise-induced Hearing LossPhase 2NCT02257983
Protective Effects of EPI-743 on Noise-Induced Hearing Loss
A Phase 2 study testing EPI-743 in people with Noise-induced Hearing Loss, run by Edison Pharmaceuticals Inc at 1 site in United States.
Trial summary
If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Noise-induced Hearing Loss
- What is being tested?
- EPI-743
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2014to 29 Feb 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Noise-induced Hearing Loss
- Being tested
- EPI-743, Placebo
- Keywords
- hearing, noise, oxidative stress
- Medical subject headings
- Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPI-743Drug
Also called 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.
PlaceboDrug
Also called Matching placebo
2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.
| Study group | Role | What they receive |
|---|---|---|
| EPI-743 | Active comparator | EPI-743 400 mg P.O. TID Receives: Drug: EPI-743 |
| Placebo | Placebo comparator | Sesame Oil, NF in sealed gelatin capsules to match the test product Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure tone audiometry
Measured: 9 days
Secondary outcomes (1)
Time to recovery following acute noise exposure
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study start31 Oct 2014
- Primary completion30 Nov 2015
- Study completion29 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noise-induced Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edison Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colleen Le Prell, Ph.D, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257983
- Sponsor's protocol ID
- EPI743-14-026
- Status last verified
- Nov 2020
- First submitted
- 11 Aug 2014
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A Randomized, Placebo Controlled, Double Blind Study of the Protective Effects of EPI-743 (VincerinoneTM) on Noise-Induced Hearing Loss
- ClinicalTrials.gov ID
- NCT02257983
- Acronym / sponsor ID
- EPI743-14-026
- Conditions
- Noise-induced Hearing Loss
- Keywords
- hearing, noise, oxidative stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Edison Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2014 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPI-743 | Active comparator | Drug: EPI-743EPI-743 400 mg P.O. TID |
| Placebo | Placebo comparator | Drug: PlaceboSesame Oil, NF in sealed gelatin capsules to match the test product |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPI-743Also: VincerinoneTM, EPI743EPI-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. | Drug | EPI-743 |
| PlaceboAlso: Matching placebo2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8. | Drug | Placebo |
Primary outcome
Pure tone audiometry
Time frame: 9 days
1 secondary outcome
Time to recovery following acute noise exposure
Time frame: 9 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen Le Prell, Ph.D principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EPI-743 in people with Noise-induced Hearing Loss, run by Edison Pharmaceuticals Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pure tone audiometry (time frame: 9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.