Study to Evaluate SPI-1005 in Adults With Meniere's Disease

This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease.

Inclusion Criteria: * Diagnosis of probable or definite Meniere's Disease by AAO-HNS 1995 criteria within 12 months of study enrollment; * Voluntarily consent to participate in the study; * Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: * Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or * IUD in place for at least 3 months prior to study through study completion; or * Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or * Stable hormonal contraceptive for at least 3 months prior to study through study completion; or * Surgical sterilization (vasectomy) of partner at least 6 months prior to study. * Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses. Exclusion Criteria: * Current use or within 90 days prior to study of ototoxic medications such as aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide); * History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma; * History of middle ear or inner ear surgery; * Current conductive hearing loss or middle ear effusion; * Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease; * History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen; * Current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes; * Participation in another investigational drug or device study within 90 days prior to study enrollment; * Female patients who are pregnant or breastfeeding.