SPI-1005 (ebselen) oral treatment for Meniere's disease.

Open-Label Study of SPI-1005 for the Treatment of Meniere's Disease

This trial will test whether taking SPI-1005 (ebselen) twice daily is safe for adults aged 18–75 with probable or definite Meniere's disease over 6 or 12 months.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sound Pharmaceuticals, Incorporated (industry)
• Drugs / interventions: chemotherapy
• Locations: 8 sites (Los Angeles, California and 7 other locations)
• Trial ID: NCT06859788 on ClinicalTrials.gov

What this trial studies

This open-label Phase 3 trial gives adults with probable or definite Meniere's disease SPI-1005 (ebselen) 400 mg twice daily for either 6 or 12 months to support potential chronic or intermittent use. Enrollment requires diagnosis by AAO-HNS amended 2015 criteria, at least two active symptoms within 3 months, a type A tympanogram, and air conduction thresholds ≤ 90 dB across tested frequencies. The study focuses on safety monitoring during long-term oral administration and excludes participants with recent use of known ototoxic IV or intratympanic medications. Study visits occur at clinical sites in Los Angeles and South Florida with serial audiologic and safety assessments.

Who should consider this trial

Good fit: Adults aged 18–75 with probable or definite Meniere's disease by AAO-HNS criteria who have had at least two active symptoms within the past 3 months, a type A tympanogram, and air conduction thresholds ≤ 90 dB are ideal candidates.

Not a fit: Patients who recently received IV or intratympanic ototoxic drugs, have a history of otosclerosis or vestibular schwannoma, or who fall outside the 18–75 age range may not benefit or be eligible for this trial.

Why it matters

Potential benefit: If successful, this could support SPI-1005 as a safe oral option for longer-term management of Meniere's disease symptoms.

How similar studies have performed: Smaller prior studies of ebselen have suggested potential protective effects on hearing in other contexts, but long-term safety and effectiveness specifically for Meniere's disease remain unproven.

Eligibility criteria

Inclusion Criteria:

* Adult males/females, 18-75 years of age at the time of enrollment.
* Diagnosis of probable or definite Meniere's Disease by AAO-HNS Amended 2015 Criteria.
* At least two of three active symptoms (fluctuating hearing; tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease, within 3 months of study enrollment.
* Type A tympanogram at screening.
* Air conduction thresholds ≤ 90 dB at all tested frequencies (250-8000 Hz) in both ears.
* Subject is willing and able to provide informed consent and perform study procedures and assessments per protocol.
* Reproductive requirements

Exclusion Criteria:

* Current, or within 60 days prior to study enrollment, use of IV or intratympanic ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.
* History of otosclerosis or vestibular schwannoma.
* History of significant middle ear or inner ear surgery in the affected ear.
* Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss.
* Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease.
* Current use or within 30 days prior to study enrollment systemic steroids.
* Current use or within 7 days prior to study enrollment intratympanic steroids.
* Hypersensitivity or idiosyncratic reaction to compounds related to ebselen or excipients.
* Female patients who are pregnant or breastfeeding.
* Participation in another investigational drug or device study within 30 days prior to study consent.
* Participant resides more than 100 miles from the study site.

Where this trial is running

Los Angeles, California and 7 other locations

• The House Institute — Los Angeles, California, United States (RECRUITING)
• ENT and Allergy Associates of Florida — Boca Raton, Florida, United States (RECRUITING)
• University of Miami — Miami, Florida, United States (NOT_YET_RECRUITING)
• Northwell Health — New Hyde Park, New York, United States (RECRUITING)
• ENT and Allergy Associates, LLP — New York, New York, United States (NOT_YET_RECRUITING)
• Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
• University of Texas Southwestern — Dallas, Texas, United States (NOT_YET_RECRUITING)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (NOT_YET_RECRUITING)

Conditions: Meniere's Disease, Ménière's Disease, ebselen, hearing loss, tinnitus, vertigo, dizziness, SPI-1005