NCT06859788
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Active, Not Recruiting
PHASE3Ages 18–75InterventionalTreatmentSound Pharmaceuticals, Incorporated
~200 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Ebselen
At a glance
Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events
Measured over 180 and 360 days
Conditions
Where it's being run
9 sites across 7 statesFlorida2
New York2
California1
Pennsylvania1
South Carolina1
Texas1
Wisconsin1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Incidence of Treatment-Emergent Adverse Events180 and 360 days
Safety and tolerability assessed based on adverse events