Actively Recruiting
SPI-1005 in Adults Receiving Cochlear Implant
Led by Sound Pharmaceuticals, Incorporated · Updated on 2025-08-11
40
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
S
Sound Pharmaceuticals, Incorporated
Lead Sponsor
M
Med-El Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
SPI-1005 in Adults Receiving Cochlear Implant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults who are 18 years of age at time of consent
- Post-lingual, bilateral, severe to profound sensorineural hearing loss scheduled to receive a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear
- Air conduction thresholds at baseline in the ear scheduled to receive the cochlear implant: 40 and 70 dB HL at 125, 250, and 500 Hz; AND 80 dB HL at 2000 through 8000 Hz
- Willing and able to provide informed consent and to perform all behavioral tests as specified per-protocol, including pre-specified reproductive requirements
You will not qualify if you...
- Current, or within 60 days prior to study enrollment, use of IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide
- Participation in another investigational drug or device study within 90 days prior to study enrollment
- Female patients who are pregnant or breastfeeding
- Air conduction thresholds at baseline in the ear scheduled to receive the cochlear implant with any No Response at 125 through 8000 Hz
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
J
Jonathan Kil, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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