SPI-1005 in Adults Receiving Cochlear Implant

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Sound Pharmaceuticals, Incorporated
Study ID
NCT06340633
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cochlear Trauma
  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ebselen — DRUG
    Glutathione peroxidase mimetic
  • Placebo — DRUG
    Matching placebo containing excipients

Study Details

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.

Key Dates

Start date
Dec 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SPI-1005 400 mg twice daily (BID)
    Oral administration of ebselen (SPI-1005) 400 mg BID for 180 days
  • Placebo Comparator: Placebo
    Oral administration of matching placebo BID for 180 days

Primary Outcome Measure

Number of Participants with Treatment Emergent Adverse Events (TEAE) [ Time Frame: 12 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Lead Clinical Research Coordinator
[email protected]
319-356-8320
Ohio State UniversityColumbusOhio43212
Beth Miles-Markley
[email protected]
614-366-9244
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Morgan Kyser
[email protected]
(215) 955-6760
Medical University of South CarolinaCharlestonSouth Carolina29425
Research Director
[email protected]
(843)792-1356
University of Texas SouthwesternDallasTexas75390
Paula Arellano-Cruz
[email protected]
214-648-8096
Medical College of WisconsinMilwaukeeWisconsin53226
Clinical Research Coordinator
[email protected]
414.955.0822

Find similar trials in Iowa City, IA

By research site
University of Iowa· Iowa City, IAOhio State University· Columbus, OHThomas Jefferson University· Philadelphia, PAMedical University of South Carolina· Charleston, SCUniversity of Texas Southwestern· Dallas, TXMedical College of Wisconsin· Milwaukee, WI

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