Tinnitus, BilateralPhase 1/2REACTNCT07826507
A Study Testing Safety and Efficacy of Transtympanic Paliroden for the Treatment of Cochlear Synaptopathy in Participants With Chronic, Constant Tinnitus
A Phase 1/2 study testing paliroden (CIL001) in people with Tinnitus, Bilateral and Cochlear Synaptopathy, run by Cilcare SAS.
Trial summary
The goal of this clinical trial is to investigate if paliroden (CIL001) is safe and can help treat cochlear synaptopathy in adult participants 18-75 years of age with normal hearing thresholds and normal cognition who exhibit chronic, constant tinnitus in both ears and have difficulty understanding speech in noisy… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tinnitus, Bilateral, Cochlear Synaptopathy
- What is being tested?
- paliroden (CIL001)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Native speaker of English
- Able and willing to give consent for the study
- Age 18-75 years (inclusive) at the time of signing the informed consent
- Report binaural, chronic, constant, subjective tinnitus for at least 6 months
- Hearing thresholds within normal limits (≤ 20 dB HL at 0.25 to 8 kHz, plus 3 and 6 kHz)
- Speech-in-noise deficit (at least 3 dB SNR loss in comparison to normative value of the AE-Matrix test) in both ears
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- No concurrent tinnitus treatment
- Be considered as reliable and capable of adhering to the protocol, according to the judgment of the investigator
- Signed informed consent as described in § 11.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Who cannot join
- Montreal Cognitive Assessment (MoCA) score < 26
- History of somatic/objective tinnitus as defined by AAO-HNS guidelines (e.g., pulsatile/whooshing sounds pulsating in synchrony with heartbeat, or caused by temporo-mandibular joint dysfunction)
- Known otologic pathology (e.g., otosclerosis, history of autoimmune hearing loss, radiation-induced hearing loss, fluctuating hearing, endolymphatic hydrops, Ménière's disease, vestibular schwannoma, history of sudden sensorineural hearing loss, Neurofibromatosis Type 2)
- History of otologic surgery (apart from tympanostomy tube insertion if more than one year prior to inclusion visit)
- Untreated hypothyroidism
- Use of prohibited concomitant therapies as described in § 6.10
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- Current use or history of platinum-based chemotherapy
- Concurrent malignancies that require treatment
- Abnormal otoscopy as defined by less than 90% of the tympanic membrane visible (e.g., occluding cerumen, ear drum perforation)
- Current middle ear pathology (e.g., otitis media, tympanic membrane perforation)
- Abnormal tympanogram (other than type A)
- Conductive hearing loss (> 10 dB difference between air- and bone-conduction hearing thresholds)
- Asymmetric hearing thresholds (more than 15 dB difference between left and right ear) at 0.25 to 8 kHz, plus 3 and 6 kHz
- Lactation, known pregnancy, positive pregnancy test at either Screening (urine) or Baseline (serum) for Women of Childbearing Potential (WOCBP), or plan to become pregnant during the study
- Liver Enzyme Lab Outcomes within the previous 2 months (or assessed at Baseline if not available at Screening ), see § 12.1.1:
- Bilirubin > upper limit normal (ULN)
- Liver transaminases (Aspartate Aminotransferase [AST] and Alanine Aminotransferase [ALT]) > 2 times ULN
- Gamma-glutamyltransferase (GGT) > 2 times ULN
- Clinically significant electrocardiogram (ECG) abnormalities:
- Marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 450 ms)
- History of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Concurrent participation in another clinical study or participation in another clinical study within 30 days or five half-lives of the experimental drug (whichever is longer) prior to screening visit (V0)
- 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
- Major surgery (at the discretion of the Principal Investigator or medically qualified designee) within eight weeks before screening or scheduled/planned surgery within the time frame of the study
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Phase 1b/2a Clinical Trial to Evaluate The Safety, Tolerability, Pharmacokinetics, and Efficacy of a Transtympanic Injection of Paliroden (CIL001) for the Treatment of Cochlear Synaptopathy in Participants With Chronic, Constant Tinnitus
The goal of this clinical trial is to investigate if paliroden (CIL001) is safe and can help treat cochlear synaptopathy in adult participants 18-75 years of age with normal hearing thresholds and normal cognition who exhibit chronic, constant tinnitus in both ears and have difficulty understanding speech in noisy environments. The main questions it aims to answer are:
- Is the study drug safe and tolerable over 6 months after injection into the middle ear?
- How much of the study drug is in the bloodstream at different time points after injection?
- How effective is a single dose of the study drug at treating cochlear synaptopathy in participants with chronic, constant tinnitus, as measured by hearing and listening tests?
Read more
Injection of the study drug will be compared to injection of a placebo (a substance with no study drug in it) to see if there is a difference.
Participants will be screened for eligibility and potentially receive a one-time injection into the middle ear of paliroden or placebo. The study lasts approximately 6 to 7 months if completing the whole study. Based on the visit windows, this could be between 190 and 218 days including a maximum of 42 days for Screening \& Run-in and 175 days post-treatment.
Participants will:
- Visit the clinic for checkups and tests multiple times over the course of the study
- Complete a large battery of hearing and listening tests, answer questionnaires about their experiences, and provide blood samples for various tests
- Receive an injection of either the study drug or placebo (a substance that has no active drug in it), if eligible
- Conditions
- Tinnitus, Bilateral, Cochlear Synaptopathy
- Being tested
- paliroden (CIL001), Placebo
- Keywords
- hearing, listening, tinnitus, ringing in the ear, cochlear synaptopathy, speech-in-noise difficulty
- Medical subject headings
- Tinnitus, Hearing Loss, Hidden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paliroden (CIL001)Drug
One-time unilateral transtympanic injection of 0.4mL of paliroden (CIL001)
PlaceboDrug
One-time unilateral transtympanic injection of 0.4mL of non-matching placebo
| Study group | Role | What they receive |
|---|---|---|
| paliroden (CIL001) | Experimental | Those receiving a one-time unilateral transtympanic injection of 0.4mL of paliroden (CIL001) Receives: Drug: paliroden (CIL001) |
| Placebo | Placebo comparator | Those receiving a one-time unilateral transtympanic injection of 0.4mL of non-matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) from baseline to 6 months (168 days). Safety data, including all observed AEs with a particular focus on ear and auditory symptomatology.
Measured: From baseline to 6 months (168 days) after injection
Secondary outcomes (4)
Determine the concentration in plasma of paliroden with Area under the plasma concentration versus time curve (AUC)
Measured: From the day of injection to 28 days
Determine the concentration in plasma of paliroden with Peak Plasma Concentration (Cmax)
Measured: From the day of injection to 28 days
Determine the time to maximum plasma concentration (Tmax).
Measured: From the day of injection to 28 days
Change from baseline in auditory function using speech-in-noise intelligibility as measured by the English (US) Matrix Test (AE-Matrix) and Time Compressed Words.
For AE-Matrix: Speech level will be fixed at 65 dB HL, while noise level will be adjusted based on responses to determine levels at which participants obtained a speech reception threshold of 50% (in dB).
For Time Compressed Words: This test consists of 50 carrier phrase and word stimuli from the Northwestern University Auditory Test No. 6 (NU-6) pool of 200 words that are compressed 60% (i.e., 60% of the carrier phrase and word has been removed). Participants will be asked to repeat the words they hear. Speech will be presented at 55 dB HL. Performance will be assessed by counting the number of words repeated correctly.
Measured: From baseline to day 28, day 56, day 84, and day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cilcare SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826507
- Sponsor's protocol ID
- REACT
- Acronym
- REACT
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Phase 1b/2a Clinical Trial to Evaluate The Safety, Tolerability, Pharmacokinetics, and Efficacy of a Transtympanic Injection of Paliroden (CIL001) for the Treatment of Cochlear Synaptopathy in Participants With Chronic, Constant Tinnitus
- ClinicalTrials.gov ID
- NCT07826507
- Acronym / sponsor ID
- REACT / REACT
- Conditions
- Tinnitus, Bilateral, Cochlear Synaptopathy
- Keywords
- hearing, listening, tinnitus, ringing in the ear, cochlear synaptopathy, speech-in-noise difficulty
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cilcare SASIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate if paliroden (CIL001) is safe and can help treat cochlear synaptopathy in adult participants 18-75 years of age with normal hearing thresholds and normal cognition who exhibit chronic, constant tinnitus in both ears and have difficulty understanding speech in noisy environments. The main questions it aims to answer are:
- Is the study drug safe and tolerable over 6 months after injection into the middle ear?
- How much of the study drug is in the bloodstream at different time points after injection?
- How effective is a single dose of the study drug at treating cochlear synaptopathy in participants with chronic, constant tinnitus, as measured by hearing and listening tests?
Injection of the study drug will be compared to injection of a placebo (a substance with no study drug in it) to see if there is a difference.
Participants will be screened for eligibility and potentially receive a one-time injection into the middle ear of paliroden or placebo. The study lasts approximately 6 to 7 months if completing the whole study. Based on the visit windows, this could be between 190 and 218 days including a maximum of 42 days for Screening \& Run-in and 175 days post-treatment.
Participants will:
- Visit the clinic for checkups and tests multiple times over the course of the study
- Complete a large battery of hearing and listening tests, answer questionnaires about their experiences, and provide blood samples for various tests
- Receive an injection of either the study drug or placebo (a substance that has no active drug in it), if eligible
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paliroden (CIL001) | Experimental | Drug: paliroden (CIL001)Those receiving a one-time unilateral transtympanic injection of 0.4mL of paliroden (CIL001) |
| Placebo | Placebo comparator | Drug: PlaceboThose receiving a one-time unilateral transtympanic injection of 0.4mL of non-matching placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Native speaker of English
- Able and willing to give consent for the study
- Age 18-75 years (inclusive) at the time of signing the informed consent
- Report binaural, chronic, constant, subjective tinnitus for at least 6 months
- Hearing thresholds within normal limits (≤ 20 dB HL at 0.25 to 8 kHz, plus 3 and 6 kHz)
Key exclusion criteria (24 listed)
- Montreal Cognitive Assessment (MoCA) score < 26
- History of somatic/objective tinnitus as defined by AAO-HNS guidelines (e.g., pulsatile/whooshing sounds pulsating in synchrony with heartbeat, or caused by temporo-mandibular joint dysfunction)
- Known otologic pathology (e.g., otosclerosis, history of autoimmune hearing loss, radiation-induced hearing loss, fluctuating hearing, endolymphatic hydrops, Ménière's disease, vestibular schwannoma, history of sudden sensorineural hearing loss, Neurofibromatosis Type 2)
- History of otologic surgery (apart from tympanostomy tube insertion if more than one year prior to inclusion visit)
- Untreated hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paliroden (CIL001)One-time unilateral transtympanic injection of 0.4mL of paliroden (CIL001) | Drug | paliroden (CIL001) |
| PlaceboOne-time unilateral transtympanic injection of 0.4mL of non-matching placebo | Drug | Placebo |
Primary outcome
Incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) from baseline to 6 months (168 days). Safety data, including all observed AEs with a particular focus on ear and auditory symptomatology.
Time frame: From baseline to 6 months (168 days) after injection
4 secondary outcomes
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
Determine the concentration in plasma of paliroden with Peak Plasma Concentration (Cmax)
Time frame: From the day of injection to 28 days
Determine the time to maximum plasma concentration (Tmax).
Time frame: From the day of injection to 28 days
Change from baseline in auditory function using speech-in-noise intelligibility as measured by the English (US) Matrix Test (AE-Matrix) and Time Compressed Words.
Time frame: From baseline to day 28, day 56, day 84, and day 168
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing paliroden (CIL001) in people with Tinnitus, Bilateral and Cochlear Synaptopathy, run by Cilcare SAS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) from baseline to 6 months (168 days). Safety data, including all observed AEs with a particular focus on ear and auditory symptomatology. (time frame: From baseline to 6 months (168 days) after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.