SPI-1005 in Adults Receiving Cochlear Implant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSound Pharmaceuticals, Incorporated
About this trial
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 criteria
Qualifiers
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.
≤70 dB HL at 125, 250, and 500 Hz; AND
≥70 dB HL at 2000, 4000, and 8000 Hz.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Ebselen
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sound Pharmaceuticals, Incorporated
Lead sponsor
Med-El Corporation
Collaborator
Source ClinicalTrials.gov