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

Running, not enrolling · Phase 3

Conditions studied: Meniere's Disease, Ménière's Disease

In brief

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.

Key facts

Study ID

NCT06859788

Run by

Sound Pharmaceuticals, Incorporated

People needed

200

Starts

2025-10-29

Expected to finish

2026-12-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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