An expanded access record providing Ebselen in Meniere's Disease, Meniere Disease and Meniere´s Disease, sponsored by Sound Pharmaceuticals, Incorporated. Temporarily not available. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Sound Pharmaceuticals, Incorporated · Expanded access
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.
74 studies on the registry are indexed under Meniere Disease; 12 are open to participants now.
Browse Meniere Disease studies →Sound Pharmaceuticals, Incorporated is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: SPI-1005, SPI-1005 400mg
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.
No contact was published for this record. The registry link below has the sponsor’s details.
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Sound Pharmaceuticals, Incorporated