SPI-1005 in Adults Receiving Cochlear Implant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ebselen, Placebo.
- Who it may be relevant to
- Registry conditions: Hearing Loss, Cochlear Trauma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Adults Receiving a Cochlear Implant
Overview
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.
Interventions
- Drug Ebselen
Glutathione peroxidase mimetic - Drug Placebo
Matching placebo containing excipients
Primary outcome measures
- Number of Participants with Treatment Emergent Adverse Events (TEAE) [Time frame: 12 months]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- University of Iowa — Iowa City
- Ohio State University — Columbus
- Thomas Jefferson University — Philadelphia
- Medical University of South Carolina — Charleston
- University of Texas Southwestern — Dallas
- Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT06340633 · SPI-1005-261