A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss — PANIHL  

Noise Induced Hearing Loss Clinical Trial

Official title: A Phase 2b, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Noise-Induced
• Noise Induced Hearing Loss

• NCT number: NCT02779192
• Study type: Interventional
• Source: Sound Pharmaceuticals, Incorporated
• Contact: Jonathan Kil, MD
• Phone: 2066342559
• Email: jkil@soundpharma.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2018
• Completion date: October 2021