Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2025-08-31
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SPI-1005 400 mg twice daily (BID)
Oral administration of ebselen (SPI-1005) 400 mg BID for 180 days
Ebselen
Glutathione peroxidase mimetic
Placebo
Oral administration of matching placebo BID for 180 days
Placebo
Matching placebo containing excipients
Interventions
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Ebselen
Glutathione peroxidase mimetic
Placebo
Matching placebo containing excipients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Med-El Corporation
INDUSTRY
Sound Pharmaceuticals, Incorporated
INDUSTRY
Responsible Party
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Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Research Director
Role: primary
Other Identifiers
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SPI-1005-261
Identifier Type: -
Identifier Source: org_study_id
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