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SPI-1005 for Adults Receiving Cochlear Implants

This study is testing a drug called Ebselen (also known as SPI-1005) in adults who are getting a cochlear implant. A cochlear implant is a device that helps people with severe hearing loss. The study aims to see if Ebselen is safe and well-tolerated, and what side effects participants might experience. Researchers also want to see if Ebselen can help with hearing, understanding speech, ringing in the ears (tinnitus), or dizziness (vertigo) after getting a cochlear implant. You may be able to join if you are an adult aged 18 or older with moderate to profound hearing loss who is scheduled to receive a specific type of cochlear implant. The study plans to enroll 40 participants, but its current status is unclear.

Study design
This study involves testing Ebselen against a placebo (an inactive substance) in 40 participants. The study's main goal is to track any medical problems participants might have over 12 months.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-related side effects for 12 months after starting the study.

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NCT06340633

SPI-1005 in Adults Receiving Cochlear Implant

Recruiting
PHASE2Ages 18+InterventionalTreatment
Sound Pharmaceuticals, Incorporated
~40 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:EbselenPlacebo

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment Emergent Adverse Events (TEAE)
Measured over 12 months

Conditions

Hearing Loss
Cochlear Trauma

Explore related trials

Hearing Loss

Where it's being run

6 sites across 6 states
Iowa1
Ohio1
Pennsylvania1
South Carolina1
Texas1
Wisconsin1

Who to contact

Jonathan Kil, MD
[email protected]
2066342559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • 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.