SPI-1005 in Adults Receiving Cochlear Implant

Last updated: August 6, 2025
Sponsor: Sound Pharmaceuticals, Incorporated
Overall Status: Active - Recruiting

Phase

2

Condition

Deafness

Hearing Loss

Hearing Impairment

Treatment

Ebselen

Placebo

Clinical Study ID

NCT06340633
SPI-1005-261
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Adults who are ≥18 years of age at time of consent.

  • Post-lingual, bilateral, severe to profound sensorineural hearing loss scheduled toreceive a long electrode array (FLEX26 or greater) from MED-EL Cochlear ImplantSystems into one ear.

  • Air conduction thresholds (decibel hearing loss, dB HL) at baseline in the earscheduled 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 asspecified per-protocol, including pre-specified reproductive requirements.

Exclusion

Exclusion Criteria:

  • Current, or within 60 days prior to study enrollment, use of IV ototoxic medicationssuch as chemotherapy including cisplatin, carboplatin, or oxaliplatin;aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, orstreptomycin; or loop diuretics including furosemide.

  • Participation in another investigational drug or device study within 90 days priorto study enrollment.

  • Female patients who are pregnant or breastfeeding.

  • Air conduction thresholds at baseline in the ear scheduled to receive the cochlearimplant with any No Response at 125 through 8000 Hz.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Ebselen
Phase: 2
Study Start date:
August 01, 2025
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

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