SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.
Randomized, double-blind, placebo-controlled, safety and efficacy study of oral SPI-1005 in adults with Noise Induced Hearing Loss (NIHL). All recruited subjects will have their severity of NIHL determined before the start of SPI-1005 treatment using various hearing tests. Subjects will be enrolled and randomized to either placebo or SPI-1005. Subjects will be dosed with either placebo or SPI-1005 for 7 days, beginning 1 day before an acute NIHL. Subjects will have hearing tests performed before and immediately after a calibrated sound challenge (CSC). Follow-up hearing tests will be performed post-CSC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days
Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days
Oral SPI-1005 capsules, 0 mg ebselen, twice daily, 7 days
University of Miami
Miami, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
MUSC
Charleston, South Carolina, United States
University of Texas Southwestern
Dallas, Texas, United States
Reduction in the Incidence of a Significant Threshold Shift
Post Controlled Sound Challenge pure tone audiometry will be compared with baseline
Time frame: Within 1 day
Improvement in word recognition score
Post Controlled Sound Challenge Words in Noise Test score will be compared with baseline
Time frame: Within 1 day
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Sound Pharmaceuticals, Inc.
Seattle, Washington, United States