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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Adults who are ≥18 years of age at time of consent.
* Post-lingual, bilateral, moderate 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 (decibel hearing loss, dB HL) at baseline in the ear scheduled to receive the cochlear implant:
* ≤70 dB HL at 125, 250, and 500 Hz; AND
* ≥70 dB HL at 2000, 4000, and 8000 Hz.
* Type A (including As and Ad) tympanogram at baseline in the ear scheduled to receive the cochlear implant.
* Willing and able to provide informed consent and to perform all behavioral tests as specified per-protocol, including pre-specified reproductive requirements.
Exclusion Criteria:
* Current, or within 60 days prior to study consent, 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 consent.
* Female patients who are pregnant or breastfeeding.
* Moderate or severe hepatic impairment using Child-Pugh Score (\>6 points).
* No measurable air conduction response at three or more consecutive test frequencies (e.g., 2000, 4000 and 8000 Hz) at baseline in the ear scheduled to receive the cochlear implant.
* No middle ear mobility (Type B tympanogram) or abnormal middle ear pressure (exceeds -150 to +50 range).
Primary outcome measure(s)
Number of Participants with Treatment Emergent Adverse Events (TEAE) — 12 months Number and severity of adverse events in patients treated with placebo versus SPI-1005.
Outcome Measure 1 includes all adverse events, including those which are not reported in the Adverse Event module, i.e., adverse events which did not result in death, were not Serious Adverse Events, and which were below the frequency threshold (5%) in any arm as required for reporting.
Trial sites (6)
Facility
City
Region
Status
University of Iowa
Iowa City
Iowa
Recruiting
Ohio State University
Columbus
Ohio
Recruiting
Thomas Jefferson University
Philadelphia
Pennsylvania
Recruiting
Medical University of South Carolina
Charleston
South Carolina
Recruiting
University of Texas Southwestern
Dallas
Texas
Recruiting
Medical College of Wisconsin
Milwaukee
Wisconsin
Not Yet Recruiting
More Sound Pharmaceuticals, Incorporated trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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