At a glance
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Phase 2 Study of the Safety and Efficacy of an Oral Formulation of SPI-1005 for Prevention of Temporary Auditory Threshold Shift
In Brief
A Phase 2 clinical trial evaluating SPI-1005 Low dose, SPI-1005 Middle dose, and 2 other interventions for Temporary Auditory Threshold Shift. Completed, enrolled 83 participants across 1 site.
Detailed Summary
Exposure to loud sounds can cause hearing loss. The purpose of this research study is to evaluate potential prevention of temporary changes in hearing that may occur after listening to music through an iPod or personal music player. We will measure temporary changes in hearing in subjects who listen to music and take either the study drug, SPI-1005, or a placebo for 4 days. SPI-1005 is a proprietary preparation of ebselen that allows it to be taken by mouth. Ebselen contains the mineral selenium and behaves like Glutathione Peroxidase, an enzyme that helps to rid the body of damaging chemicals caused by loud sounds.
Study Details
Timeline
Interventions
Oral capsules, 200 mg ebselen, twice daily, 4 days
Oral capsules, 400 mg ebselen, twice daily, 4 days
Oral capsules, 600 mg ebselen, twice daily, 4 days
Oral capsules, 0 mg ebselen, twice daily, 4 days