Hearing LossPhase 2NCT06340633
SPI-1005 in Adults Receiving Cochlear Implant
A Phase 2 study testing Ebselen in people with Hearing Loss and Cochlear Trauma, run by Sound Pharmaceuticals, Incorporated at 6 sites in United States.
Trial summary
The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Cochlear Trauma
- What is being tested?
- Ebselen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2026to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults who are ≥18 years of age at time of consent.
- Post-lingual, bilateral, moderate to profound sensorineural hearing loss scheduled to receive a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.
- Air conduction thresholds (decibel hearing loss, dB HL) at baseline in the ear scheduled to receive the cochlear implant:
- ≤70 dB HL at 125, 250, and 500 Hz; AND
- ≥70 dB HL at 2000, 4000, and 8000 Hz.
- Type A (including As and Ad) tympanogram at baseline in the ear scheduled to receive the cochlear implant.
- Willing and able to provide informed consent and to perform all behavioral tests as specified per-protocol, including pre-specified reproductive requirements.
Who cannot join
- Current, or within 60 days prior to study consent, use of IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.
- Participation in another investigational drug or device study within 90 days prior to study consent.
- Female patients who are pregnant or breastfeeding.
- Moderate or severe hepatic impairment using Child-Pugh Score (>6 points).
- No measurable air conduction response at three or more consecutive test frequencies (e.g., 2000, 4000 and 8000 Hz) at baseline in the ear scheduled to receive the cochlear implant.
- No middle ear mobility (Type B tympanogram) or abnormal middle ear pressure (exceeds -150 to +50 range).
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Research Director, (843)792-1356, nguyensh@musc.edu
- Recruiting
Ohio State University
Columbus, Ohio, 43212
Beth Miles-Markley, 614-366-9244, beth.miles-markley@osumc.edu
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Paula Arellano-Cruz, 214-648-8096, paula.arellano-cruz@utsouthwestern.edu
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Lead Clinical Research Coordinator, 319-356-8320, kesten-anderson@uiowa.edu
- Not yet recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Clinical Research Coordinator, 414.955.0822, smleziva@mcw.edu
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Morgan Kyser, (215) 955-6760, morgan.kyser@jefferson.edu
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Adults Receiving a Cochlear Implant
The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.
The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005?
Read more
The clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant.
Participants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests.
The effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.
- Conditions
- Hearing Loss, Cochlear Trauma
- Being tested
- Ebselen, Placebo
- Keywords
- Hearing Preservation, Cochlear Implant, SPI-1005, Ebselen
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EbselenDrug
Also called SPI-1005
Glutathione peroxidase mimetic
PlaceboDrug
Matching placebo containing excipients
| Study group | Role | What they receive |
|---|---|---|
| SPI-1005 400 mg twice daily (BID) | Experimental | Oral administration of ebselen (SPI-1005) 400 mg BID for 180 days Receives: Drug: Ebselen |
| Placebo | Placebo comparator | Oral administration of matching placebo BID for 180 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events (TEAE)
Number and severity of adverse events in patients treated with placebo versus SPI-1005.
Outcome Measure 1 includes all adverse events, including those which are not reported in the Adverse Event module, i.e., adverse events which did not result in death, were not Serious Adverse Events, and which were below the frequency threshold (5%) in any arm as required for reporting.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study startDec 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sound Pharmaceuticals, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Med-El Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340633
- Sponsor's protocol ID
- SPI-1005-261
- Status last verified
- May 2026
- First submitted
- 25 Mar 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Adults Receiving a Cochlear Implant
- ClinicalTrials.gov ID
- NCT06340633
- Acronym / sponsor ID
- SPI-1005-261
- Conditions
- Hearing Loss, Cochlear Trauma
- Keywords
- Hearing Preservation, Cochlear Implant, SPI-1005, Ebselen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sound Pharmaceuticals, IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Med-El Corporation
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Apr 2024 (actual)
- 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.
The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.
The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005?
The clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant.
Participants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests.
The effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPI-1005 400 mg twice daily (BID) | Experimental | Drug: EbselenOral administration of ebselen (SPI-1005) 400 mg BID for 180 days |
| Placebo | Placebo comparator | Drug: PlaceboOral administration of matching placebo BID for 180 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults who are ≥18 years of age at time of consent.
- Post-lingual, bilateral, moderate to profound sensorineural hearing loss scheduled to receive a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.
- Air conduction thresholds (decibel hearing loss, dB HL) at baseline in the ear scheduled to receive the cochlear implant:
- Type A (including As and Ad) tympanogram at baseline in the ear scheduled to receive the cochlear implant.
- Willing and able to provide informed consent and to perform all behavioral tests as specified per-protocol, including pre-specified reproductive requirements.
Key exclusion criteria (6 listed)
- Current, or within 60 days prior to study consent, use of IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.
- Participation in another investigational drug or device study within 90 days prior to study consent.
- Female patients who are pregnant or breastfeeding.
- Moderate or severe hepatic impairment using Child-Pugh Score (>6 points).
- No measurable air conduction response at three or more consecutive test frequencies (e.g., 2000, 4000 and 8000 Hz) at baseline in the ear scheduled to receive the cochlear implant.
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 |
|---|---|---|
| EbselenAlso: SPI-1005Glutathione peroxidase mimetic | Drug | SPI-1005 400 mg twice daily (BID) |
| PlaceboMatching placebo containing excipients | Drug | Placebo |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events (TEAE)
Time frame: 12 months
Number and severity of adverse events in patients treated with placebo versus SPI-1005. Outcome Measure 1 includes all adverse events, including those which are not reported in the Adverse Event module, i.e., adverse events which did not result in death, were not Serious Adverse Events, and which were below the frequency threshold (5%) in any arm as required for reporting.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 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.
6 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 Ebselen in people with Hearing Loss and Cochlear Trauma, run by Sound Pharmaceuticals, Incorporated at 6 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 7 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: looking for participants now, as of the sponsor's last update on 26 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 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Kil, MD (2066342559, info@soundpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events (TEAE) (time frame: 12 months). 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 26 Jun 2026.