Clinical trials

The goal of this clinical trial is to investigate if paliroden (CIL001) is safe and can help treat cochlear synaptopathy in adult participants 18-75 years of age with normal hearing thresholds and normal cognition who exhibit chronic, constant tinnitus in both ears and have difficulty understanding speech in noisy environments. The main questions it aims to answer are: * Is the study drug safe and tolerable over 6 months after injection into the middle ear? * How much of the study drug is in the bloodstream at different time points after injection? * How effective is a single dose of the study drug at treating cochlear synaptopathy in participants with chronic, constant tinnitus, as measured by hearing and listening tests? Injection of the study drug will be compared to injection of a placebo (a substance with no study drug in it) to see if there is a difference. Participants will be screened for eligibility and potentially receive a one-time injection into the middle ear of paliroden or placebo. The study lasts approximately 6 to 7 months if completing the whole study. Based on the visit windows, this could be between 190 and 218 days including a maximum of 42 days for Screening \& Run-in and 175 days post-treatment. Participants will: * Visit the clinic for checkups and tests multiple times over the course of the study * Complete a large battery of hearing and listening tests, answer questionnaires about their experiences, and provide blood samples for various tests * Receive an injection of either the study drug or placebo (a substance that has no active drug in it), if eligible

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.

The study aims to phenotype hearing in patients with early stage of neurodegenerative disorders to explore the prevalence of various hearing disorders in comparison to a control population. Specific focus is made on patients with speech-in-noise intelligibiltiy deficit despite normal tonal audiograms referred to as hidden hearing loss, with potential identification of associated biomarkers.