Condition: Hearing Loss · Cochlear Trauma · Sponsor: Sound Pharmaceuticals, Incorporated
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.
This description comes directly from the study's public registry record.
Jonathan Kil, MD · 2066342559 · info@soundpharma.com
Always discuss trial participation with your own doctor first.
| University of Iowa | Iowa City, Iowa, United States | Recruiting |
| Ohio State University | Columbus, Ohio, United States | Recruiting |
| Thomas Jefferson University | Philadelphia, Pennsylvania, United States | Recruiting |
| Medical University of South Carolina | Charleston, South Carolina, United States | Recruiting |
| University of Texas Southwestern | Dallas, Texas, United States | Recruiting |
| Medical College of Wisconsin | Milwaukee, Wisconsin, United States | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06340633