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Study to Evaluate SPI-1005 in Adults With Meniere's Disease
Sponsor: Sound Pharmaceuticals, Incorporated
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.
Official title: Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease
Key Details
Gender
All
Age Range
19 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2015-12
Completion Date
2017-08
Last Updated
2026-06-29
Healthy Volunteers
No
Conditions
Interventions
SPI-1005
Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Locations (5)
House Clinic
Los Angeles, California, United States
New York Otology
New York, New York, United States
MUSC
Charleston, South Carolina, United States
Sound Pharmaceuticals, Inc.
Seattle, Washington, United States
Northwest Ear
Seattle, Washington, United States