A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden… (NCT07472907) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
135 participantsStarted 2026-08
Plain-language summary
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.
Who can participate
Age range
45 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Participants must be native speakers of the official language(s) of the country in which the study assessments are conducted.
. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test upon entry into this study. In addition, they must agree to use highly effective contraception methods, as defined by regulatory guidance (e.g., combined hormonal contraception, intrauterine device, or surgical sterilization), from the screening visit, for the duration of study treatment and for 30 days after dosing.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequencies of Treatment-Related Adverse Events with a particular focus on ear and auditory symptomatology
. Normal hearing as defined by PTAv (0.5-1-2kHz-4Khz) \<25dB in both ears.
. Up to mild hearing loss in the high-frequency range (PTAvHF (4-6-8kHz) \<40dB) in both ears.
Exclusion criteria
. 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)
. Previous or concurrent malignancies that require treatment and are not clinically stable
. Current evidence or history of retrocochlear pathology (e.g., acoustic neuroma)
. History of otologic surgery (apart from tympanostomy tube insertion if more than one year prior to inclusion visit)
. Abnormal otoscopy as defined by less than 90% of the tympanic membrane visible (e.g., cerumen ear plug, ear drum perforation). In case of cerumen plugs not affecting the hearing results, a removal must be scheduled before V1 (baseline/inclusion).