Randomized, double-blind, placebo-controlled, multicenter phase IIa clinical trial in adult male TCa patients with the risk to suffer from sensorineural hearing loss (SNHL) due to cisplatin therapy within a chemotherapeutic regimen of testicular cancer. Patients will have an indication for a cisplatin-containing chemotherapy according to current guidelines and trial site tumor board recommendations. The trial is designed to show efficacy, safety, and tolerability of ACOU085 administered into the middle ear using 3 transtympanic injections per ear prior to 3 planned and corresponding 3-week chemotherapeutic cycles. The intra-individual control will be done by placebo injection into the respective contralateral middle ear.
Confirmed diagnosis of testicular cancer with indication for a cis-Pt-containing chemotherapeutic regimen according to current treatment guidelines and site-specific tumor board recommendations
Male adult patients at an age between 18 and 45 years
Planned cis-Pt treatment with a cumulative dose of ≥300 mg/m2 which has to be administered in three chemotherapeutic cycles
Normal or not clinically relevant otoscopic findings in both ears
Suspected or diagnosed genetic predisposition to hearing loss (incl. DFNA2 rel. to KCNQ4)
History of middle ear pathology or surgery, otitis externa, chronic otitis media, or recent acute otitis media (within ≤3 months)
History of otologic surgery (excluding myringotomy tubes or simple tympanoplasty)
Meniere's disease or secondary endolymphatic hydrops, auto immune hearing loss, inner ear pathology, fluctuating hearing loss, perilymph fistula, cochlear baro-trauma, radiation-induced hearing loss, retro-cochlear lesion, severe tympanosclerosis, atrophic tympanic membrane
Parallel
ACOU085 (bimokalner)
DrugTranstympanic injection
Placebo
DrugTranstympanic injection
PTA air
Proportion of patients showing a difference of ≥10 dB between the ears in at least two frequencies for air conduction in PTA focused on high (4, 6, 8 kHz) and extended high frequencies (10, 12, 14, 16 kHz) between baseline (V1; prior to first initiation of cis-Pt-containing chemotherapy) and end of chemotherapeutic cycle 3 (V4)
Distortion Product Otoacoustic Emissions (DPOAE)
Intraindividual differences between the ears at Visits 2-5
PTA bone
Intraindividual differences between the ears at Visits 2-5
Oldenburger Test (speech understanding)
Intraindividual differences between the ears at Visits 2-5
Freiburger Test
Intraindividual differences between the ears at Visits 2-5
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