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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
StatusNot Yet Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
5,087 trials monitored
See 222 trials at risk
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
(from sponsor)
Cochlear Synaptopathy
Related terms Diabetes Mellitus, Hearing Loss, Hidden
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov