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RECRUITING
NCT06340633
PHASE2

SPI-1005 in Adults Receiving Cochlear Implant

Sponsor: Sound Pharmaceuticals, Incorporated

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-12

Completion Date

2026-12

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

DRUG

Ebselen

Glutathione peroxidase mimetic

DRUG

Placebo

Matching placebo containing excipients

Locations (2)

University of Iowa

Iowa City, Iowa, United States

Medical University of South Carolina

Charleston, South Carolina, United States