Temporary Auditory Threshold ShiftPhase 2NCT01444846

Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift

A Phase 2 study testing SPI-1005 Low dose, SPI-1005 Middle dose and SPI-1005 High dose in people with Temporary Auditory Threshold Shift, run by Sound Pharmaceuticals, Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 31 yearsHealthy volunteers can take part
Conditions the study is for: Temporary Auditory Threshold Shift
What is being tested?: SPI-1005 Low dose, SPI-1005 Middle dose and SPI-1005 High dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 83 participants
Where: 1 siteUnited States
Study dates: Sep 2011to Mar 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 31 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy subjects at the time of enrollment.
Each subject will give informed consent to participate in this study and agrees to the treatment protocol.
Each subject will be interviewed regarding hearing and health to reveal any history of hearing loss, tinnitus, known ear pathology, use of any potentially ototoxic medications (i.e. diuretics, minocycline).
Non-occupational sound exposure (e.g., concerts, firearms, fireworks, power tools) will be avoided during the 24-hour period preceding baseline testing and throughout the duration of the study.
Subjects will have vital signs (i.e., heart rate, blood pressure, respirations, temperature) within normal limits upon medical examination.
Subjects must have normal audiologic assessment at baseline consisting of:

Show all 10Show fewer

Baseline audiometric evaluation confirms that subjects have symmetric hearing with air conduction thresholds no worse than 25 decibels of Hearing Loss (dBHL) at frequencies between 0.25 to 8 kilo Hertz (kHz) bilaterally.
No significant threshold asymmetry (i.e. greater than 15 dB) between the ears at any tested frequency.
No significant air-bone gaps (i.e. greater than 10 dB)
Type A tympanograms bilaterally, defined as a range of -140 to +40 dekaPascals (daPa) based on the 90% range for adults (Margolis and Hunter 2000)

Who cannot join

• Subjects with abnormal hearing levels > 25 dBHL at any tested frequency (250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz) for either ear.
Exposure to any duration of non-occupational high-level sound (e.g., concerts, firearms, fireworks, power tools) during the 24 hour period preceding baseline audiometric testing as revealed in the subject questionnaire or during the medical examination.
Pathology of the external ear discovered upon otoscopic examination.
Pathology of the middle ear revealed by otoscopic examination, abnormal tympanometry, or reported history of middle ear problems.
Pathology of the inner ear or auditory nerve as revealed by reported history.
Subject complaints of aural pain, pressure, fullness, or drainage.

Show all 12Show fewer

Subjects testing positive for pregnancy will be excluded from the study.
Subjects with other medical/health issues that would preclude voluntary participation in a drug study may be excluded at the discretion of the Principal Investigator.
Subjects that have previously received any known potentially ototoxic medication. This includes, but is not limited to, high dose salicylates (>2 g/day), platinum-based chemotherapeutics and aminoglycoside antibiotics, such as streptomycin, gentamicin,tobramycin, amikacin, neomycin, and netilmycin.
Subjects that are currently using of any potentially ototoxic medications (i.e. diuretics or minocycline).
Subjects that have received any investigational treatment (drug or device) in the six months prior to this study.
Subjects exhibiting or self-reporting shortness of breath, wheezing, coughing, or hemoptysis

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida
Gainesville, Florida, 32610

Other trials in United States

About this study

Official title: Phase 2 Study of the Safety and Efficacy of an Oral Formulation of SPI-1005 for Prevention of Temporary Auditory Threshold Shift

Exposure to loud sounds can cause hearing loss. The purpose of this research study is to evaluate potential prevention of temporary changes in hearing that may occur after listening to music through an iPod or personal music player. We will measure temporary changes in hearing in subjects who listen to music and take either the study drug, SPI-1005, or a placebo for 4 days. SPI-1005 is a proprietary preparation of ebselen that allows it to be taken by mouth. Ebselen contains the mineral selenium and behaves like Glutathione Peroxidase, an enzyme that helps to rid the body of damaging chemicals caused by loud sounds.

Read the detailed description

The objective of this study was to determine the safety and efficacy of SPI-1005 in the prevention of sensorineural hearing loss or temporary auditory threshold shift (TTS) using pure tone audiometry. Subjects with normal to slight hearing loss were screened on clinic visit day 1 (CV1) and after satisfying specific otologic inclusion and exclusion criteria, were enrolled and randomized to either SPI-1000 (placebo) or one of three doses of ebselen (SPI-1005): 200, 400 or 600 mg. Subjects began taking placebo or SPI-1005 by mouth for four days beginning two days prior to CV2. On CV2 subjects had their blood drawn for peak/trough analysis of ebselen and metabolites and their baseline hearing thresholds determined by audiometry. Subjects were then exposed to 100 decibels (dBA) of sound delivered from a calibrated iPod® via insert earphones for 4 continuous hours. Subjects had their hearing serially tested at 4 additional times post-noise exposure on the same day to determine their threshold shift. Subjects returned to clinic 24 hours later on CV3 and 7 days later on CV4 for additional safety and efficacy assessments including repeat audiometry. Efficacy was determined by comparing the threshold shift in an SPI-1005 treated group vs placebo.

Exposure to SPI-1005 (ebselen and the major and minor metabolites) was quantified from plasma by LC-MS/MS. The plasma values from the peak/trough sampling were taken before and after the 5th oral dose on Clinic Visit 2 (CV2) when subjects were expected to be at steady-state. Plasma selenium levels were quantified by ICP-MS prior to dosing at CV1, at CV2 during peak/trough sampling for ebselen and metabolites, and at CV4 or 5 days after the last scheduled dose.

The multi-dose safety of SPI-1005 was determined by repeated History \& Physical examinations, serology (Chemistry Panel-20), hematology (CBC with differential), and radiology (chest x-rays). Safety was determined by comparing the changes in laboratory values in SPI-1005 groups vs placebo.

Conditions: Temporary Auditory Threshold Shift
Being tested: SPI-1005 Low dose, SPI-1005 Middle dose, SPI-1005 High dose, Placebo
Keywords: Temporary Auditory Threshold Shift, Hearing Loss, Deafness, SPI-1005, Ebselen
Medical subject headings: Hearing Loss, Deafness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SPI-1005 Low doseDrug
Also called 200 mg Ebselen
Oral capsules, 200 mg ebselen, twice daily, 4 days
SPI-1005 Middle doseDrug
Also called 400 mg Ebselen
Oral capsules, 400 mg ebselen, twice daily, 4 days
SPI-1005 High doseDrug
Also called 600mgEbselen
Oral capsules, 600 mg ebselen, twice daily, 4 days
PlaceboDrug
Also called 0 mg Ebselen
Oral capsules, 0 mg ebselen, twice daily, 4 days

Study groups in NCT01444846
Study group	Role	What they receive
SPI-1005 Low dose	Active comparator	200mg SPI-1005, capsule, bid, po, x4d Receives: Drug: SPI-1005 Low dose
SPI-1005 Middle Dose	Active comparator	400mg SPI-1005, capsule, bid, po, x4d Receives: Drug: SPI-1005 Middle dose
SPI-1005 High Dose	Active comparator	600mg SPI-1005, capsule, bid, po, x4d Receives: Drug: SPI-1005 High dose
Placebo	Placebo comparator	0mg SPI-1005, capsule, bid, po, x4d Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Temporary Threshold Shift at 4 kHz--Intent To Treat (ITT) Population
The primary efficacy analysis was change in air conduction threshold at 4 kHz collected in the ITT Population on the day of sound exposure. Baseline hearing thresholds were collected on Clinic Visit 2 prior to sound exposure and used in calculating the primary efficacy endpoints. Hearing thresholds after sound exposure were collected and compared to baseline threshold to calculate change from baseline. Threshold changes from baseline were determined for each ear, frequency, and post sound time point, then analyzed by Mixed-effects Model Repeated Measures (MMRM) methods using triply repeated measurements for each subject. The MMRM had fixed effects for treatment, ear, frequency, and time, all 2-way interactions and the 3-way interaction treatment by-frequency-by-time plus a random effect for subject nested within treatment.
Measured: 15 minutes post Controlled Sound Challenge
Change in Temporary Threshold Shift at 4 kHz--Per Protocol (PP) Population
The primary efficacy analysis was change in air conduction threshold at 4 kHz collected in the PP Population on the day of sound exposure. Baseline hearing thresholds were collected on Clinic Visit 2 prior to sound exposure and used in calculating the primary efficacy endpoints. Hearing thresholds after sound exposure were collected and compared to baseline threshold to calculate change from baseline. Threshold changes from baseline were determined for each ear, frequency, and post sound time point, then analyzed by Mixed-effects Model Repeated Measures (MMRM) methods using triply repeated measurements for each subject. The MMRM had fixed effects for treatment, ear, frequency, and time, all 2-way interactions and the 3-way interaction treatment by-frequency-by-time plus a random effect for subject nested within treatment.
Measured: 15 minutes post Controlled Sound Challenge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Mar 2014

First posted3 Oct 2011 (estimated)
Study startSep 2011
Primary completionDec 2013
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Temporary Auditory Threshold ShiftStudies 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: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01444846
Sponsor's protocol ID: SPI-1005-202
Status last verified: Jun 2026
First submitted: 29 Sep 2011
Last updated: 3 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Pourbakht A, Yamasoba T. Ebselen attenuates cochlear damage caused by acoustic trauma. Hear Res. 2003 Jul;181(1-2):100-8. doi: 10.1016/s0378-5955(03)00178-3.
PubMed 12855368
Lynch ED, Gu R, Pierce C, Kil J. Ebselen-mediated protection from single and repeated noise exposure in rat. Laryngoscope. 2004 Feb;114(2):333-7. doi: 10.1097/00005537-200402000-00029.
PubMed 14755214
Lynch ED, Gu R, Pierce C, Kil J. Reduction of acute cisplatin ototoxicity and nephrotoxicity in rats by oral administration of allopurinol and ebselen. Hear Res. 2005 Mar;201(1-2):81-9. doi: 10.1016/j.heares.2004.08.002.
PubMed 15721563
Yamasoba T, Pourbakht A, Sakamoto T, Suzuki M. Ebselen prevents noise-induced excitotoxicity and temporary threshold shift. Neurosci Lett. 2005 Jun 3;380(3):234-8. doi: 10.1016/j.neulet.2005.01.047. Epub 2005 Feb 1.
PubMed 15862892
Lynch ED, Kil J. Compounds for the prevention and treatment of noise-induced hearing loss. Drug Discov Today. 2005 Oct 1;10(19):1291-8. doi: 10.1016/S1359-6446(05)03561-0.
PubMed 16214673
Kil J, Pierce C, Tran H, Gu R, Lynch ED. Ebselen treatment reduces noise induced hearing loss via the mimicry and induction of glutathione peroxidase. Hear Res. 2007 Apr;226(1-2):44-51. doi: 10.1016/j.heares.2006.08.006. Epub 2006 Oct 6.
PubMed 17030476
Lynch E, Kil J. Development of Ebselen, a Glutathione Peroxidase Mimic, for the Prevention and Treatment of Noise-Induced Hearing Loss. Semin Hear 2009; 30(1): 047-055
Le Prell CG, Yang Q, Harris JG. Modification of digital music files for use in human temporary threshold shift studies. J Acoust Soc Am. 2011 Oct;130(4):EL142-6. doi: 10.1121/1.3630017.
PubMed 21974483
Le Prell CG, Dell S, Hensley B, Hall JW 3rd, Campbell KC, Antonelli PJ, Green GE, Miller JM, Guire K. Digital music exposure reliably induces temporary threshold shift in normal-hearing human subjects. Ear Hear. 2012 Nov-Dec;33(6):e44-58. doi: 10.1097/AUD.0b013e31825f9d89.
PubMed 22885407
Kil J, Lobarinas E, Spankovich C, Griffiths SK, Antonelli PJ, Lynch ED, Le Prell CG. Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2017 Sep 2;390(10098):969-979. doi: 10.1016/S0140-6736(17)31791-9. Epub 2017 Jul 14.
PubMed 28716314
Spankovich C, Le Prell CG. Associations between dietary quality, noise, and hearing: data from the National Health and Nutrition Examination Survey, 1999-2002. Int J Audiol. 2014 Nov;53(11):796-809. doi: 10.3109/14992027.2014.921340. Epub 2014 Jun 30.
PubMed 24975234

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Study of the Safety and Efficacy of an Oral Formulation of SPI-1005 for Prevention of Temporary Auditory Threshold Shift
ClinicalTrials.gov ID: NCT01444846
Acronym / sponsor ID: SPI-1005-202
Conditions: Temporary Auditory Threshold Shift
Keywords: Temporary Auditory Threshold Shift, Hearing Loss, Deafness, SPI-1005, Ebselen
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Sound Pharmaceuticals, IncorporatedIndustry (pharma, biotech, devices)
Collaborators: University of Florida
Study start: Sep 2011
Primary completion: Dec 2013 (actual)
Study completion: Mar 2014 (actual)
First posted: 3 Oct 2011 (estimated)
Results: Posted 3 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
SPI-1005 Low dose	Active comparator	Drug: SPI-1005 Low dose200mg SPI-1005, capsule, bid, po, x4d
SPI-1005 Middle Dose	Active comparator	Drug: SPI-1005 Middle dose400mg SPI-1005, capsule, bid, po, x4d
SPI-1005 High Dose	Active comparator	Drug: SPI-1005 High dose600mg SPI-1005, capsule, bid, po, x4d
Placebo	Placebo comparator	Drug: Placebo0mg SPI-1005, capsule, bid, po, x4d

Who may qualify

Ages: 18 to 31 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Healthy subjects at the time of enrollment.
Each subject will give informed consent to participate in this study and agrees to the treatment protocol.
Each subject will be interviewed regarding hearing and health to reveal any history of hearing loss, tinnitus, known ear pathology, use of any potentially ototoxic medications (i.e. diuretics, minocycline).
Non-occupational sound exposure (e.g., concerts, firearms, fireworks, power tools) will be avoided during the 24-hour period preceding baseline testing and throughout the duration of the study.
Subjects will have vital signs (i.e., heart rate, blood pressure, respirations, temperature) within normal limits upon medical examination.

Key exclusion criteria (12 listed)

• Subjects with abnormal hearing levels > 25 dBHL at any tested frequency (250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz) for either ear.
Exposure to any duration of non-occupational high-level sound (e.g., concerts, firearms, fireworks, power tools) during the 24 hour period preceding baseline audiometric testing as revealed in the subject questionnaire or during the medical examination.
Pathology of the external ear discovered upon otoscopic examination.
Pathology of the middle ear revealed by otoscopic examination, abnormal tympanometry, or reported history of middle ear problems.
Pathology of the inner ear or auditory nerve as revealed by reported history.

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
SPI-1005 Low doseAlso: 200 mg EbselenOral capsules, 200 mg ebselen, twice daily, 4 days	Drug	SPI-1005 Low dose
SPI-1005 Middle doseAlso: 400 mg EbselenOral capsules, 400 mg ebselen, twice daily, 4 days	Drug	SPI-1005 Middle Dose
SPI-1005 High doseAlso: 600mgEbselenOral capsules, 600 mg ebselen, twice daily, 4 days	Drug	SPI-1005 High Dose
PlaceboAlso: 0 mg EbselenOral capsules, 0 mg ebselen, twice daily, 4 days	Drug	Placebo

Primary outcome

Change in Temporary Threshold Shift at 4 kHz--Intent To Treat (ITT) Population
Time frame: 15 minutes post Controlled Sound Challenge
The primary efficacy analysis was change in air conduction threshold at 4 kHz collected in the ITT Population on the day of sound exposure. Baseline hearing thresholds were collected on Clinic Visit 2 prior to sound exposure and used in calculating the primary efficacy endpoints. Hearing thresholds after sound exposure were collected and compared to baseline threshold to calculate change from baseline. Threshold changes from baseline were determined for each ear, frequency, and post sound time point, then analyzed by Mixed-effects Model Repeated Measures (MMRM) methods using triply repeated measurements for each subject. The MMRM had fixed effects for treatment, ear, frequency, and time, all 2-way interactions and the 3-way interaction treatment by-frequency-by-time plus a random effect for subject nested within treatment.
Change in Temporary Threshold Shift at 4 kHz--Per Protocol (PP) Population
Time frame: 15 minutes post Controlled Sound Challenge
The primary efficacy analysis was change in air conduction threshold at 4 kHz collected in the PP Population on the day of sound exposure. Baseline hearing thresholds were collected on Clinic Visit 2 prior to sound exposure and used in calculating the primary efficacy endpoints. Hearing thresholds after sound exposure were collected and compared to baseline threshold to calculate change from baseline. Threshold changes from baseline were determined for each ear, frequency, and post sound time point, then analyzed by Mixed-effects Model Repeated Measures (MMRM) methods using triply repeated measurements for each subject. The MMRM had fixed effects for treatment, ear, frequency, and time, all 2-way interactions and the 3-way interaction treatment by-frequency-by-time plus a random effect for subject nested within treatment.

Results and safety

Results posted to the registry on 3 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SPI-1005 Low Dose	22	20
SPI-1005 Middle Dose	20	20
SPI-1005 High Dose	21	21
Placebo	20	19

Primary outcome: Change in Temporary Threshold Shift at 4 kHz--Intent To Treat (ITT) Population

Time frame: 15 minutes post Controlled Sound Challenge. Mean (95% Confidence Interval). Unit: dbHL

Measure	SPI-1005 Low Dose n = 20	SPI-1005 Middle Dose n = 20	SPI-1005 High Dose n = 21	Placebo n = 20
Value	3.23 (1.97 to 4.49)	1.32 (0.06 to 2.58)	3.81 (2.57 to 5.04)	4.07 (2.81 to 5.34)

SPI-1005 Low Dose vs SPI-1005 Middle Dose vs SPI-1005 High Dose vs Placebo: p <0.05, Mixed Models Analysis
SPI-1005 Low Dose vs SPI-1005 Middle Dose vs SPI-1005 High Dose vs Placebo: p <0.05, Mixed Models Analysis

Population analysed: Intent To Treat (ITT) Population

Primary outcome: Change in Temporary Threshold Shift at 4 kHz--Per Protocol (PP) Population

Time frame: 15 minutes post Controlled Sound Challenge. Mean (95% Confidence Interval). Unit: dB HL

Measure	SPI-1005 Low Dose n = 19	SPI-1005 Middle Dose n = 20	SPI-1005 High Dose n = 18	Placebo n = 20
Value	3.35 (2.07 to 4.64)	1.30 (0.05 to 2.55)	3.69 (2.37 to 5.01)	4.09 (2.84 to 5.35)

SPI-1005 Low Dose vs SPI-1005 Middle Dose vs SPI-1005 High Dose vs Placebo: p <0.05, Mixed Models Analysis
SPI-1005 Low Dose vs SPI-1005 Middle Dose vs SPI-1005 High Dose vs Placebo: p <0.05, Mixed Models Analysis

Population analysed: Analysis of the Per Protocol population includes all subjects (n=77) that were noise exposed, and completed the protocol as directed.

Adverse events

Time frame: AEs were collected over a period of roughly 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SPI-1005 Low Dose	0 of 22 (0%)	3 of 22 (13.6%)	Not reported
SPI-1005 Middle Dose	0 of 20 (0%)	5 of 20 (25%)	Not reported
SPI-1005 High Dose	0 of 21 (0%)	4 of 21 (19%)	Not reported
Placebo	0 of 20 (0%)	2 of 20 (10%)	Not reported

Limitations and caveats (from the sponsor): The primary limitations of this study are small sample size and results from a single center. The data collected is supportive of continued evaluation of SPI-1005 for prevention of Temporary Auditory Threshold shift in larger multi-center trials.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12855368Pourbakht A, Yamasoba T. Ebselen attenuates cochlear damage caused by acoustic trauma. Hear Res. 2003 Jul;181(1-2):100-8. doi: 10.1016/s0378-5955(03)00178-3.
Background: PubMed 14755214Lynch ED, Gu R, Pierce C, Kil J. Ebselen-mediated protection from single and repeated noise exposure in rat. Laryngoscope. 2004 Feb;114(2):333-7. doi: 10.1097/00005537-200402000-00029.
Background: PubMed 15721563Lynch ED, Gu R, Pierce C, Kil J. Reduction of acute cisplatin ototoxicity and nephrotoxicity in rats by oral administration of allopurinol and ebselen. Hear Res. 2005 Mar;201(1-2):81-9. doi: 10.1016/j.heares.2004.08.002.
Background: PubMed 15862892Yamasoba T, Pourbakht A, Sakamoto T, Suzuki M. Ebselen prevents noise-induced excitotoxicity and temporary threshold shift. Neurosci Lett. 2005 Jun 3;380(3):234-8. doi: 10.1016/j.neulet.2005.01.047. Epub 2005 Feb 1.
Background: PubMed 16214673Lynch ED, Kil J. Compounds for the prevention and treatment of noise-induced hearing loss. Drug Discov Today. 2005 Oct 1;10(19):1291-8. doi: 10.1016/S1359-6446(05)03561-0.
Background: PubMed 17030476Kil J, Pierce C, Tran H, Gu R, Lynch ED. Ebselen treatment reduces noise induced hearing loss via the mimicry and induction of glutathione peroxidase. Hear Res. 2007 Apr;226(1-2):44-51. doi: 10.1016/j.heares.2006.08.006. Epub 2006 Oct 6.
BackgroundLynch E, Kil J. Development of Ebselen, a Glutathione Peroxidase Mimic, for the Prevention and Treatment of Noise-Induced Hearing Loss. Semin Hear 2009; 30(1): 047-055
Background: PubMed 21974483Le Prell CG, Yang Q, Harris JG. Modification of digital music files for use in human temporary threshold shift studies. J Acoust Soc Am. 2011 Oct;130(4):EL142-6. doi: 10.1121/1.3630017.
Background: PubMed 22885407Le Prell CG, Dell S, Hensley B, Hall JW 3rd, Campbell KC, Antonelli PJ, Green GE, Miller JM, Guire K. Digital music exposure reliably induces temporary threshold shift in normal-hearing human subjects. Ear Hear. 2012 Nov-Dec;33(6):e44-58. doi: 10.1097/AUD.0b013e31825f9d89.
Derived from this study: PubMed 28716314Kil J, Lobarinas E, Spankovich C, Griffiths SK, Antonelli PJ, Lynch ED, Le Prell CG. Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2017 Sep 2;390(10098):969-979. doi: 10.1016/S0140-6736(17)31791-9. Epub 2017 Jul 14.
Derived from this study: PubMed 24975234Spankovich C, Le Prell CG. Associations between dietary quality, noise, and hearing: data from the National Health and Nutrition Examination Survey, 1999-2002. Int J Audiol. 2014 Nov;53(11):796-809. doi: 10.3109/14992027.2014.921340. Epub 2014 Jun 30.
Individual participant dataSharing planned: No

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, PhD principal investigator

University of Florida

Jonathan Kil, MD study director

Sound Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 12 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 3 Jun 2026. 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?

Yes. Results are posted in the registry (first posted 3 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Temporary Threshold Shift at 4 kHz--Intent To Treat (ITT) Population (time frame: 15 minutes post Controlled Sound Challenge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01444846, which also lists 11 linked publications.

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 3 Jun 2026.