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

Sound Pharmaceuticals

Status and phase

Not yet enrolling

Phase 3

Conditions

Meniere's Disease

Ménière's Disease

Treatments

Drug: Ebselen

Study type

Interventional

Funder types

Industry

Identifiers

NCT06859788

SPI-1005-401

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.