NCT06340633 SPI-1005 in Adults Receiving Cochlear Implant
| NCT ID | NCT06340633 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sound Pharmaceuticals, Incorporated |
| Condition | Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-12 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2026-12 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06340633 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06340633 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06340633 currently recruiting?
Yes, NCT06340633 is actively recruiting participants. Contact the research team at info@soundpharma.com for enrollment information.
Where is the NCT06340633 trial being conducted?
This trial is being conducted at Iowa City, United States, Columbus, United States, Philadelphia, United States, Charleston, United States and 2 additional locations.
Who is sponsoring the NCT06340633 clinical trial?
NCT06340633 is sponsored by Sound Pharmaceuticals, Incorporated. The trial plans to enroll 40 participants.