Noise Induced Hearing LossPhase 2PANIHLNCT02779192
A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss
A Phase 2 study testing SPI-1005 200mg and SPI-1005 400mg in people with Noise Induced Hearing Loss, run by Sound Pharmaceuticals, Incorporated at 5 sites in United States.
Trial summary
SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Noise Induced Hearing Loss
- What is being tested?
- SPI-1005 200mg and SPI-1005 400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2026to Jun 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult male or female patients, 18-50 years of age
- History of either recreational and/or occupational exposure to noise
- Voluntarily consent to participate in the study
- Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or intra-uterine device in place for at least 3 months prior to study through study completion; or barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or stable hormonal contraceptive for at least 3 months prior to study through study completion; or surgical sterilization (vasectomy) of partner at least 6 months prior to study.
- Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses.
Who cannot join
- Current use or within 60 days prior to study of excluded ototoxic medications
- History of autoimmune inner ear disease
- History of middle ear or inner ear surgery
- Current conductive hearing loss or middle ear effusion
- Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease
- History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen
Show all 9Show fewer
- Current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes
- Participation in another investigational drug or device study within 90 days prior to study enrollment
- Female patients who are pregnant or breastfeeding
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
MUSC
Charleston, South Carolina, 29425
University of Texas Southwestern
Dallas, Texas, 75390
University of Kansas Medical Center
Kansas City, Kansas, 66103
University of Miami
Miami, Florida, 33136
Sound Pharmaceuticals, Inc.
Seattle, Washington, 98103
About this study
Official title: A Phase 2b, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)
SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.
Read the detailed description
Randomized, double-blind, placebo-controlled, safety and efficacy study of oral SPI-1005 in adults with Noise Induced Hearing Loss (NIHL). All recruited subjects will have their severity of NIHL determined before the start of SPI-1005 treatment using various hearing tests. Subjects will be enrolled and randomized to either placebo or SPI-1005. Subjects will be dosed with either placebo or SPI-1005 for 7 days, beginning 1 day before an acute NIHL. Subjects will have hearing tests performed before and immediately after a calibrated sound challenge (CSC). Follow-up hearing tests will be performed post-CSC.
- Conditions
- Noise Induced Hearing Loss
- Being tested
- SPI-1005 200mg, SPI-1005 400mg, Placebo
- Keywords
- Acute Noise Induced Hearing Loss, Prevent Acute Noise Induced Hearing Loss
- 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.
SPI-1005 200mgDrug
Also called Low Dose
Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days
SPI-1005 400mgDrug
Also called High Dose
Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days
PlaceboDrug
Also called Control
Oral SPI-1005 capsules, 0 mg ebselen, twice daily, 7 days
| Study group | Role | What they receive |
|---|---|---|
| SPI-1005 200 mg | Active comparator | 200 mg SPI-1005, capsule, bid, po, x7d Receives: Drug: SPI-1005 200mg |
| SPI-1005 400 mg | Active comparator | 400 mg SPI-1005, capsule, bid, po, x7d Receives: Drug: SPI-1005 400mg |
| Placebo | Placebo comparator | 0 mg SPI-1005, capsule, bid, po, x7d Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the Incidence of a Significant Threshold Shift
Post Controlled Sound Challenge pure tone audiometry will be compared with baseline
Measured: Within 1 day
Secondary outcomes (1)
Improvement in word recognition score
Post Controlled Sound Challenge Words in Noise Test score will be compared with baseline
Measured: Within 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJun 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: Study did not start
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sound Pharmaceuticals, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Kil, MD, Study chair, SOUND PHARMACEUTICALS, INC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779192
- Sponsor's protocol ID
- SPI-1005-203
- Acronym
- PANIHL
- Status last verified
- Jun 2026
- First submitted
- 18 May 2016
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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
- A Phase 2b, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)
- ClinicalTrials.gov ID
- NCT02779192
- Acronym / sponsor ID
- PANIHL / SPI-1005-203
- Conditions
- Noise Induced Hearing Loss
- Keywords
- Acute Noise Induced Hearing Loss, Prevent Acute Noise Induced Hearing Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not start
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sound Pharmaceuticals, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 20 May 2016 (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.
SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.
Detailed description
Randomized, double-blind, placebo-controlled, safety and efficacy study of oral SPI-1005 in adults with Noise Induced Hearing Loss (NIHL). All recruited subjects will have their severity of NIHL determined before the start of SPI-1005 treatment using various hearing tests. Subjects will be enrolled and randomized to either placebo or SPI-1005. Subjects will be dosed with either placebo or SPI-1005 for 7 days, beginning 1 day before an acute NIHL. Subjects will have hearing tests performed before and immediately after a calibrated sound challenge (CSC). Follow-up hearing tests will be performed post-CSC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SPI-1005 200 mg | Active comparator | Drug: SPI-1005 200mg200 mg SPI-1005, capsule, bid, po, x7d |
| SPI-1005 400 mg | Active comparator | Drug: SPI-1005 400mg400 mg SPI-1005, capsule, bid, po, x7d |
| Placebo | Placebo comparator | Drug: Placebo0 mg SPI-1005, capsule, bid, po, x7d |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult male or female patients, 18-50 years of age
- History of either recreational and/or occupational exposure to noise
- Voluntarily consent to participate in the study
- Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or intra-uterine device in place for at least 3 months prior to study through study completion; or barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or stable hormonal contraceptive for at least 3 months prior to study through study completion; or surgical sterilization (vasectomy) of partner at least 6 months prior to study.
- Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses.
Key exclusion criteria (9 listed)
- Current use or within 60 days prior to study of excluded ototoxic medications
- History of autoimmune inner ear disease
- History of middle ear or inner ear surgery
- Current conductive hearing loss or middle ear effusion
- Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease
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 200mgAlso: Low DoseOral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days | Drug | SPI-1005 200 mg |
| SPI-1005 400mgAlso: High DoseOral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days | Drug | SPI-1005 400 mg |
| PlaceboAlso: ControlOral SPI-1005 capsules, 0 mg ebselen, twice daily, 7 days | Drug | Placebo |
Primary outcome
Reduction in the Incidence of a Significant Threshold Shift
Time frame: Within 1 day
Post Controlled Sound Challenge pure tone audiometry will be compared with baseline
1 secondary outcome
Improvement in word recognition score
Time frame: Within 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Jonathan Kil, MD study chair
SOUND PHARMACEUTICALS, INC.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPI-1005 200mg and SPI-1005 400mg in people with Noise Induced Hearing Loss, run by Sound Pharmaceuticals, Incorporated at 5 sites 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 5 inclusion and 9 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: withdrawn, 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 5 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Reduction in the Incidence of a Significant Threshold Shift (time frame: Within 1 day). 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 3 Jun 2026.