SPI-1005 in Adults Receiving Cochlear Implant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSound Pharmaceuticals, Incorporated
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
≤70 dB HL at 125, 250, and 500 Hz; AND
≥70 dB HL at 2000, 4000, and 8000 Hz.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Ebselen
DrugGlutathione peroxidase mimetic
Placebo
DrugMatching placebo containing excipients
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: SPI-1005 400 mg twice daily (BID)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
12 monthsOther outcomes
1
Effect of SPI-1005 on Residual Low Frequency Hearing
Residual hearing at low frequencies (≤1000 Hz) using pure tone audiometry
Time frame
12 months2
Effect of SPI-1005 on Word Recognition
Word recognition using words in quiet
Time frame
12 months3
Effect of SPI-1005 on Speech Discrimination
Speech discrimination using words in noise
Time frame
12 months4
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.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sound Pharmaceuticals, Incorporated
Lead sponsor
Med-El Corporation
Collaborator
Source ClinicalTrials.gov