Like retinopathy, neuropathy and nephropathy, sensorineural hearing loss is a common and underserved complication of uncontrolled diabetes. Neuroinflammation in diabetes can cause auditory nerve damage (cochlear synaptopathy) which first translates into speech-in-noise intelligibility deficit. CIL001 is a neurotrophic small molecule that aims to repair auditory nerve when applied locally by transtympanic injection. Transtympanic injection of paliroden is anticipated to improve the symptoms of cochlear synaptopathy. Furthermore, by addressing auditory or vestibular dysfunction early and effectively, this approach may contribute to limiting or delaying, over the long term, the onset of secondary neurological disorders, such as dementia.
Signed and dated informed consent form
Aged between 45 and 75 years old (inclusive) at the time of screening
Established type 2 diabetes as determined by 7% ≤ hemoglobin A1c (HbA1c) ≤ 9% and diabetes duration of at least 5 years
Be considered as reliable and capable of adhering to the protocol, according to the judgment of the Investigator
MoCA score < 26
Known otologic pathology (e.g., History of autoimmune hearing loss, radiation-induced hearing loss, fluctuating hearing, endolymphatic hydrops, or Menière's disease in either ear)
Presence of middle ear pathology (e.g., otitis media, tympanic membrane perforation, etc.)
History of platinum-based chemotherapy
Parallel
CIL001 (Paliroden)
DrugSingle unilateral transtympanic administration
Placebo
DrugPlacebo
Frequencies of Treatment-Related Adverse Events with a particular focus on ear and auditory symptomatology
Determine the concentration in plasma of paliroden with Area under the plasma concentration versus time curve (AUC)
Determine the concentration in plasma of paliroden with Peak Plasma Concentration (Cmax)
Determine the concentration in plasma of paliroden with Time to maximum concentration (Tmax)
Change in speech in noise intelligibility base on the SRT50 result From the Matrix test (SRT50 = Signal-to-noise ratio required to correctly understand 50% of presented speech)
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