Meniere's DiseaseNCT07873281
Expanded Access Protocol for SPI-1005
A study testing Ebselen in people with Meniere's Disease and Meniere Disease, run by Sound Pharmaceuticals, Incorporated.
Trial summary
The purpose of this protocol is to facilitate expanded access ("compassionate use") of SPI-1005 to Meniere's disease (MD) or sudden sensorineural hearing loss (SSNHL) patients who cannot gain access through ongoing clinical trial(s). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniere's Disease, Meniere Disease, Meniere´s Disease
- What is being tested?
- Ebselen
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patients with Meniere's Disease (MD) or Sudden Sensorineural Hearing Loss (SSNHL) who may benefit from SPI-1005 treatment.
- Patients must have active symptoms including hearing loss within 90 days of study consent.
- For SSNHL patients, the date of first onset of SSNHL must be between 30 days and 90 days of study consent.
- All patients should have previously received the standard of care including corticosteroid treatment (systemic or intratympanic) prior to study consent.
- Participation requires discretion and mutual agreement of patient, physician, and sponsor.
- Patients must meet and agree to comply with the contraception requirements.
Who cannot join
- Patients with severe renal and hepatic insufficiency must be excluded.
- Children (<18 years of age) and females who are pregnant or breastfeeding are not eligible.
About this study
The purpose of this protocol is to facilitate expanded access ("compassionate use") of SPI-1005 to Meniere's disease (MD) or sudden sensorineural hearing loss (SSNHL) patients who cannot gain access through ongoing clinical trial(s). Adult males and females, age 18 years or older, with Meniere's disease (MD) or sudden sensorineural hearing loss (SSNHL) who have exhausted available standard-of-care therapies and who may receive benefit from SPI-1005 treatment will be selected to participate in the Expanded Access Protocol, subject to Investigator and Sponsor discretion.
- Conditions
- Meniere's Disease, Meniere Disease, Meniere´s Disease, Meniere's Disease Aggravated, Sudden Sensorineural Hearing Loss, Sudden Sensorineural Hearing Loss (SSNHL)
- Being tested
- Ebselen
- Medical subject headings
- Meniere Disease, Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EbselenDrug
Also called SPI-1005, SPI-1005 400mg
SPI-1005 is a capsule that contains the investigational drug called ebselen. Ebselen is a new synthetic compound that has been found to reduce inflammation, remove potentially damaging oxidizing agents in the body, and provide protection to inner ear cells against harmful agents. Ebselen mimics the actions of glutathione peroxidase, a naturally occurring enzyme found in the body and the inner ear. Neither ebselen nor SPI-1005 have been approved by the FDA to treat any human disease or condition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniere's DiseaseStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Sound Pharmaceuticals, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873281
- Sponsor's protocol ID
- SPI-1005-402
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Protocol for SPI-1005
- ClinicalTrials.gov ID
- NCT07873281
- Acronym / sponsor ID
- SPI-1005-402
- Conditions
- Meniere's Disease, Meniere Disease, Meniere´s Disease, Meniere's Disease Aggravated, Sudden Sensorineural Hearing Loss, Sudden Sensorineural Hearing Loss (SSNHL)
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- Sound Pharmaceuticals, IncorporatedIndustry (pharma, biotech, devices)
- First posted
- 14 Oct 2026 (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 purpose of this protocol is to facilitate expanded access ("compassionate use") of SPI-1005 to Meniere's disease (MD) or sudden sensorineural hearing loss (SSNHL) patients who cannot gain access through ongoing clinical trial(s). Adult males and females, age 18 years or older, with Meniere's disease (MD) or sudden sensorineural hearing loss (SSNHL) who have exhausted available standard-of-care therapies and who may receive benefit from SPI-1005 treatment will be selected to participate in the Expanded Access Protocol, subject to Investigator and Sponsor discretion.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with Meniere's Disease (MD) or Sudden Sensorineural Hearing Loss (SSNHL) who may benefit from SPI-1005 treatment.
- Patients must have active symptoms including hearing loss within 90 days of study consent.
- For SSNHL patients, the date of first onset of SSNHL must be between 30 days and 90 days of study consent.
- All patients should have previously received the standard of care including corticosteroid treatment (systemic or intratympanic) prior to study consent.
- Participation requires discretion and mutual agreement of patient, physician, and sponsor.
Key exclusion criteria (2 listed)
- Patients with severe renal and hepatic insufficiency must be excluded.
- Children (<18 years of age) and females who are pregnant or breastfeeding are not eligible.
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-1005, SPI-1005 400mgSPI-1005 is a capsule that contains the investigational drug called ebselen. Ebselen is a new synthetic compound that has been found to reduce inflammation, remove potentially damaging oxidizing agents in the body, and provide protection to inner ear cells against harmful agents. Ebselen mimics the actions of glutathione peroxidase, a naturally occurring enzyme found in the body and the inner ear. Neither ebselen nor SPI-1005 have been approved by the FDA to treat any human disease or condition. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ebselen in people with Meniere's Disease and Meniere Disease, run by Sound Pharmaceuticals, Incorporated.
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 2 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: status not confirmed, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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.
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 14 Oct 2026.