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

Randomized, double-blind, placebo-controlled safety, pharmacokinetic, pharmacodynamic study of oral SPI-1005 in adults with Meniere's disease. All subjects will undergo baseline audiometric testing and have their severity of sensorineural hearing loss, tinnitus and vertigo determined before the start of a 21-day course of treatment with SPI-1005 or placebo. During treatment with SPI-1005, and 7 days and 28 days following the cessation of SPI-1005, subjects will have their hearing loss, tinnitus and vertigo assessed. Additional testing including electrocochleography will be performed at baseline, at the end of SPI-1005 treatment, and 28 days after the SPI-1005 treatment has stopped. Six outpatient visits will be performed over a 7-week period.

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.