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

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sound Pharmaceuticals, Incorporated
• Treatments: Ebselen

Criteria

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.