SPI-1005 in Adults Receiving Cochlear Implant

Launched by SOUND PHARMACEUTICALS, INCORPORATED · Mar 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called SPI-1005 to see if it is safe and effective for adults who are getting a cochlear implant. The trial focuses on individuals with severe to profound hearing loss who will receive a specific type of cochlear implant from MED-EL. The main goal is to find out if this drug can help reduce side effects like problems with hearing, understanding speech, ringing in the ears (tinnitus), or dizziness (vertigo) after the implant surgery.

To participate, you need to be at least 18 years old and have certain levels of hearing loss in the ear that will receive the cochlear implant. Participants will take the drug SPI-1005 or a placebo (a substance that looks like the drug but has no active ingredients) for six months, starting two days before the surgery. Throughout the trial, there will be five in-clinic visits to check on your hearing and overall health. This study is not currently recruiting participants, but it's an important step in understanding how to improve outcomes for people receiving cochlear implants.

Gender

ALL

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.