Clinical trial NCT06340633: SPI-1005 in Adults Receiving Cochlear Implant
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hearing Loss
Cochlear Trauma
Keywords: Hearing Preservation
Cochlear Implant
SPI-1005
Ebselen
Lead sponsor: Sound Pharmaceuticals, Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Med-El Corporation
First posted: 2024-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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 (decibel hearing loss, dB HL) 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAE)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Effect of SPI-1005 on Residual Low Frequency Hearing
timeFrame: 12 months
measure: Effect of SPI-1005 on Word Recognition
timeFrame: 12 months
measure: Effect of SPI-1005 on Speech Discrimination
timeFrame: 12 months
measure: Effect of SPI-1005 on Tinnitus
timeFrame: 12 months
measure: Effect of SPI-1005 on Vertigo
timeFrame: 12 months
Locations:
Study officials:
References: