SPI-1005 in Adults Receiving Cochlear Implant

NCT06340633 | Recruiting Phase 2 FDA Drug

• 1 other identifier: SPI-1005-261
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Hearing Loss; Cochlear Trauma

Keywords

Hearing Preservation; Cochlear Implant; SPI-1005; Ebselen

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment Emergent Adverse Events (TEAE)

  Number and severity of adverse events in patients treated with placebo versus SPI-1005. Outcome Measure 1 includes all adverse events, including those which are not reported in the Adverse Event module, i.e., adverse events which did not result in death, were not Serious Adverse Events, and which were below the frequency threshold (5%) in any arm as required for reporting.

  12 months

Other Outcomes (5)

• Effect of SPI-1005 on Residual Low Frequency Hearing

  12 months

• Effect of SPI-1005 on Word Recognition

  12 months

• Effect of SPI-1005 on Speech Discrimination

  12 months

Study Arms (2)

SPI-1005 400 mg twice daily (BID)

EXPERIMENTAL

Oral administration of ebselen (SPI-1005) 400 mg BID for 180 days

Drug: Ebselen

Placebo

PLACEBO COMPARATOR

Oral administration of matching placebo BID for 180 days

Drug: Placebo

Interventions

Ebselen DRUG

Glutathione peroxidase mimetic

Also known as: SPI-1005

SPI-1005 400 mg twice daily (BID)

Placebo DRUG

Matching placebo containing excipients

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sound Pharmaceuticals, Incorporated: lead
• Med-El Corporation: collaborator

Study Sites (6)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43212, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

University of Texas Southwestern

Dallas, Texas, 75390, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Hearing Loss

Interventions

ebselen

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jonathan Kil, MD

CONTACT

2066342559; info@soundpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)