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Clinical Trials in the USA / NCT06859788
Active, not recruiting Phase 3

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

NCT06859788 · tracked via the Priya Life Science USA tracker
Sponsor
Sound Pharmaceuticals, Incorporated
Phase
Phase 3
Started
2025-10-29
Last updated
2026-07-13

Condition(s) studied

Meniere's DiseaseMénière's Disease

Investigational drug(s) / intervention(s)

Ebselen

Ebselen: Glutathione peroxidase mimetic

Study summary

Study of the safety of open-label SPI-1005 400 mg BID treatment in adults with Meniere's Disease (MD) for 6 or 12 months to support chronic or chronic intermittent use.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
The House Institute Los Angeles California
ENT and Allergy Associates of Florida Boynton Beach Florida
ENT and Allergy Associates of Florida Delray Beach Florida
Northwell Health New Hyde Park New York
ENT and Allergy Associates, LLP New York New York
Thomas Jefferson University Philadelphia Pennsylvania
Medical University of South Carolina Charleston South Carolina
University of Texas Southwestern Dallas Texas
Medical College of Wisconsin Milwaukee Wisconsin

More Sound Pharmaceuticals, Incorporated trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06859788 on ClinicalTrials.gov ↗ ← All trials in the USA