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NOT YET RECRUITING
NCT07472907
PHASE1/PHASE2

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

Sponsor: Cilcare SAS

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.

Official title: A Randomized, Double-blind, Placebo-controlled, Ascending Volume Phase 1B/2A Clinical Trial to Investigate the Safety and Efficacy of a Single Transtympanic Injection of CIL001 (Paliroden) for the Treatment of Cochlear Synaptopathy in Participants With type2 Diabetes

Key Details

Gender

All

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2026-08

Completion Date

2027-12

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

DRUG

CIL001 (Paliroden)

Single unilateral transtympanic administration

DRUG

Placebo

Placebo