Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06340633
Other study ID # SPI-1005-261
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04696835 - fNIRS in Pediatric Hearing Aids N/A
Completed NCT03662256 - Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine N/A
Completed NCT04602780 - Evaluating the Revised WORQ in CI Users
Completed NCT03723161 - Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
Completed NCT05086809 - Investigation of an Updated Bone-anchored Sound Processor N/A
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Completed NCT03428841 - Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients N/A
Completed NCT04559282 - Home Test of New Sound Processor N/A
Enrolling by invitation NCT03345654 - Individually-guided Hearing Aid Fitting
Completed NCT06016335 - MRI-based Synthetic CT Images of the Head and Neck N/A
Completed NCT05165121 - Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids N/A
Recruiting NCT05533840 - Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
Completed NCT04622059 - AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis N/A
Terminated NCT02294812 - Effects of Cognitive Training on Speech Perception N/A
Recruiting NCT02558478 - Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing N/A
Withdrawn NCT02740322 - Validating the Hum Test N/A
Completed NCT01963104 - Community-Based Kiosks for Hearing Screening and Education N/A
Completed NCT01857661 - The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial N/A
Completed NCT01892007 - Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users N/A
Withdrawn NCT01223638 - The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism N/A