Hearing Loss study: Ebselen
Official title SPI-1005 in Adults Receiving Cochlear Implant
ClinicalTrials.gov ID: NCT06340633
What this study is testing
What is Ebselen (SPI-1005)?
An investigational oral medicine being studied for preventing or treating side effects after cochlear implant surgery. It is designed to mimic the activity of the antioxidant enzyme glutathione peroxidase.
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 study wants to find out if SPI‑1005 is safe for adults receiving a cochlear implant and whether it can reduce side effects like tinnitus and vertigo. It also looks at how the drug might affect hearing and speech understanding.
- Who it's for
- Adults who are scheduled to receive a cochlear implant with a long electrode array from MED‑EL.
- What's involved
- Participants will receive either SPI‑1005 or a placebo for six months, starting two days before the implant surgery. They will have five clinic visits for hearing tests and other assessments.
- Time commitment
- The study lasts six months, with five required in‑clinic visits during that time.
- 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...
- ≤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.
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.
- ≤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
- 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 is enrolling
- Iowa City, Iowa, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Dallas, Texas, 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, but 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?
This study is enrolling now at Iowa City, Iowa, United States; Columbus, Ohio, United States; Philadelphia, Pennsylvania, United States; Charleston, South Carolina, United States; Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.