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

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

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.

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.