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New treatment option for Hearing Loss
Official title SPI-1005 in Adults Receiving Cochlear Implant
ClinicalTrials.gov ID: NCT06340633
What this study is testing
What is Ebselen?
Ebselen is an investigational medicine, being studied as a potential treatment for hearing loss.
Also referred to as SPI-1005.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- Current, or within 60 days prior to study consent, use of IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or...
- 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...
- No middle ear mobility (Type B tympanogram) or abnormal middle ear pressure (exceeds -150 to +50 range).
See the full eligibility 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.
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Dallas, Texas, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States; Columbus, Ohio, United States; Philadelphia, Pennsylvania, United States; Charleston, South Carolina, United States; Dallas, Texas, United States; Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.