Clinical Trial

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

Study acronym: RESPLAND
Not Yet Recruiting Phase 1/2
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07472907
Lead Sponsor Cilcare SAS
Conditions Cochlear Synaptopathy
Enrollment 135 participants
Start Date 2026-08
Primary Completion 2027-07 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-16