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 (RESPLAND)

March 10, 2026 updated by: Cilcare SAS

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

135

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed and dated informed consent form
  2. Aged between 45 and 75 years old (inclusive) at the time of screening
  3. Established type 2 diabetes as determined by 7% ≤ hemoglobin A1c (HbA1c) ≤ 9% and diabetes duration of at least 5 years
  4. Be considered as reliable and capable of adhering to the protocol, according to the judgment of the Investigator
  5. Participants must be native speakers of the official language(s) of the country in which the study assessments are conducted.

  6. 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.

    The following audiology assessments, if not performed on the same day as the review of the previous criteria (e.g., when the participant's first visit does not take place at the ENT site), may be scheduled on different days within a maximum interval of 14 days after the first screening visit and must be completed at least 21 days before the baseline visit.

  7. Normal hearing as defined by PTAv (0.5-1-2kHz-4Khz) <25dB in both ears.
  8. Up to mild hearing loss in the high-frequency range (PTAvHF (4-6-8kHz) <40dB) in both ears.
  9. Speech-in-noise deficit (at least 3dB SNR loss in comparison to normative value of the Matrix test) in both ears.

Exclusion Criteria:

  1. MoCA score < 26
  2. 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)
  3. Presence of middle ear pathology (e.g., otitis media, tympanic membrane perforation, etc.)
  4. History of platinum-based chemotherapy
  5. Previous or concurrent malignancies that require treatment and are not clinically stable
  6. Current evidence or history of retrocochlear pathology (e.g., acoustic neuroma)
  7. History of otologic surgery (apart from tympanostomy tube insertion if more than one year prior to inclusion visit)
  8. 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).
  9. Hearing aids and cochlear implants.
  10. History of cancer treated by platinum-based chemotherapy.
  11. Lactation or known pregnancy or positive pregnancy test at both screening and baseline for women of childbearing potential, or planning to become pregnant during the study

  12. Liver Enzyme Lab Outcomes:

    1. Bilirubin > 2 times the upper limit of normal (ULN)
    2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (AST/ALT) >5 times ULN.
    3. Gamma glutamyltransferase (GGT) > 5 times ULN
  13. Maternally Inherited Diabetes
  14. Congenital hearing loss
  15. Untreated hypothyroidism
  16. Adult individual under legal protection as defined by applicable regulations (e.g., persons deprived of liberty, hospitalized without consent, unable to provide informed consent, or placed under legal guardianship or curatorship)
  17. Concurrent participation in another clinical study or participation in another trial involving experimental drug within 30 days or five half-lives of the experimental drug (whichever was longer) prior to screening visit (V0).
  18. Diagnosed anxiety disorders, psychosis, depression, schizophrenia, attempted suicide, or other significant psychiatric conditions that could impact their ability to cooperate and comply with the study protocol
  19. Major surgery that may impact the study conduct or outcomes within eight weeks before screening or scheduled/planned surgery within the time frame of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CIL001
Single Unilateral transtympanic administration
Drug: CIL001 (Paliroden)
Single unilateral transtympanic administration
Placebo Comparator: Placebo
Single Unilateral transtympanic administration
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequencies of Treatment-Related Adverse Events with a particular focus on ear and auditory symptomatology
Time Frame: Over 6 month (168 days) post-injection
Over 6 month (168 days) post-injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the concentration in plasma of paliroden with Area under the plasma concentration versus time curve (AUC)
Time Frame: From the day of injection to 28 days
From the day of injection to 28 days
Determine the concentration in plasma of paliroden with Peak Plasma Concentration (Cmax)
Time Frame: From the day of injection to 28 days
From the day of injection to 28 days
Determine the concentration in plasma of paliroden with Time to maximum concentration (Tmax)
Time Frame: From the day of injection to 28 days
From the day of injection to 28 days
Change in speech in noise intelligibility base on the SRT50 result From the Matrix test (SRT50 = Signal-to-noise ratio required to correctly understand 50% of presented speech)
Time Frame: At Day 84 from baseline
At Day 84 from baseline
Change in ABR Wave I amplitude (µV) measured by electrocochleography
Time Frame: Day 28, Day 84, Day 168
Day 28, Day 84, Day 168

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cilcare SAS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESPLAND
  • 2025-524383-37-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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