NCT02779192

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

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Sound Pharmaceuticals, Incorporated · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Noise Induced Hearing Loss

Interventions

Type	Name	Description
DRUG	SPI-1005 200mg	Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days
DRUG	SPI-1005 400mg	Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days
DRUG	Placebo	Oral SPI-1005 capsules, 0 mg ebselen, twice daily, 7 days

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-06-01
• Completion: 2021-10-01
• First posted: 2016-05-20
• Last updated: 2018-08-24

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study