SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Trial Parameters
Brief 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 Criteria
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