NCT06340633

SPI-1005 in Adults Receiving Cochlear Implant

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Adults Receiving a Cochlear Implant

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sound Pharmaceuticals, Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear. The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005? The clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant. Participants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests. The effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.

Conditions

• Hearing Loss
• Cochlear Trauma

Interventions

Type	Name	Description
DRUG	Ebselen	Glutathione peroxidase mimetic
DRUG	Placebo	Matching placebo containing excipients

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-04-01
• Last updated: 2025-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study