SPI-1005 in Adults Receiving Cochlear Implant

Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06340633
• Other study ID #: SPI-1005-261
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Sound Pharmaceuticals, Incorporated
• Contact: Jonathan Kil, MD
• Phone: 2066342559
• Email: info[@]soundpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults who are =18 years of age at time of consent.
• 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:

• Current, or within 60 days prior to study enrollment, 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 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.

Related Conditions & MeSH terms

• Cochlear Trauma
• Hearing Loss

Intervention

Drug:
• Ebselen
Glutathione peroxidase mimetic
• Placebo
Matching placebo containing excipients

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sound Pharmaceuticals, Incorporated	Med-El Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of SPI-1005 on Residual Low Frequency Hearing	Residual hearing at low frequencies (=1000 Hz) using pure tone audiometry	12 months
Other	Effect of SPI-1005 on Word Recognition	Word recognition using words in quiet	12 months
Other	Effect of SPI-1005 on Speech Discrimination	Speech discrimination using words in noise	12 months
Other	Effect of SPI-1005 on Tinnitus	Tinnitus severity using the Tinnitus Functional Index (TFI). TFI Total Score: 0-100, in which a higher score means a worse outcome.	12 months
Other	Effect of SPI-1005 on Vertigo	Vertigo severity using the Vertigo Symptoms Scale (VSS). VSS Total Scale: 0-60, in which a higher score means a worse outcome.	12 months
Primary	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