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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
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.
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
Incidence of of Treatment-Emergent Adverse Events
Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.
Time frame: 7 weeks
Plasma Ebselen Levels of SPI-1005 After 21 Days of Dosing
Trough values
Time frame: 21 days
Plasma Selenium Levels
Plasma selenium levels at 28 days post-treatment
Time frame: 7 weeks
Impact on Sensorineural Hearing Loss
Number of participants demonstrating improvement in Sensorineural Hearing Loss measured using pure tone audiometry. Improvement was defined as a decrease from baseline value by 10 dB or more at one or more low-frequency thresholds (0.25, 0.5, or 1.0 kHz) in at least one ear.
Time frame: 7 weeks
Impact on Speech Discrimination
Number of participants demonstrating improvement in Speech Discrimination measured using the Words in Noise test. Improvement was defined as an increase from baseline value by 10% or more in the total score (0-35, where a higher score is a better outcome) in at least one ear.
Time frame: 7 weeks
Impact on Tinnitus
Number of participants demonstrating improvement in the Tinnitus Functional Index (TFI). Improvement was defined as a decrease from baseline value by 10 points or more in the total score (0-100, where a higher score is a worse outcome).
Time frame: 7 weeks
Impact on Vertigo
Number of participants demonstrating improvement in the Vertigo Symptom Scale - Short Form (VSS). Improvement was defined as a decrease from baseline value by 6 points or more in the total score (0-60, where a higher score is a worse outcome).
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Northwest Ear
Seattle, Washington, United States
Time frame: 7 weeks