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

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.