Hearing LossPhase 2NCT05258773
Evaluation of the Presence of SENS-401 in the Perilymph
A Phase 2 study testing SENS-401 (R-Azasetron Besylate) in people with Hearing Loss, run by Sensorion at 7 sites in 2 countries.
Trial summary
The aim of this study is to detect the presence of SENS-401 in the perilymph of participants undergoing cochlear implant surgery after 7 days of oral administration of SENS-401. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- SENS-401 (R-Azasetron Besylate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 10 Aug 2022to 31 May 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
Potential participants must fulfil all of the following main inclusion criteria to be eligible for the study:
- Adults aged from 18 years and older;
- Meets the locally approved indication for cochlear implantation. The individual must have freely consented to the cochlear implant surgery before being offered to participate in the SENS-401-203 study;
- Signed and dated written informed consent;
Main Exclusion Criteria:
Individuals will be excluded from the study if any of the following main exclusion criteria apply:
- Moderate to severe renal impairment defined by a creatinine clearance ≤ 60 ml/min
- Any condition that, in the opinion of the Investigator, may compromise the safety or compliance of the participant or would preclude the participant from successful completion of the study
- Unable or unwilling to comply with the protocol requirements
- Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
France6 sites
Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin
Bordeaux
Centre Hospitalier Universitaire de Clermont-Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand
Centre Hospitalier Universitaire de Lille Hôpital Roger Salengro
Lille
Hôpital Edouard Herriot
Lyon
Groupe Hospitalier La Pitié-Salpétrière
Paris
Centre Hospitalier Universitaire de Toulouse, Hôpital Purpan
Toulouse
About this study
Official title: A Phase IIa, Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Presence of SENS-401 in the Perilymph After 7 Days of Repeated Oral Administration in Adult Participants Scheduled for Cochlear Implantation
The aim of this study is to detect the presence of SENS-401 in the perilymph of participants undergoing cochlear implant surgery after 7 days of oral administration of SENS-401.
Read the detailed description
The study is a Phase IIa, open-label, randomized and controlled study investigating repeated twice-daily administration of oral SENS-401 in adult participants with moderately severe to profound hearing loss who have already agreed to undergo cochlear implant surgery justified by their hearing impairment.
After written informed consent is obtained and screening procedures completed, 27 eligible participants will be randomized on Day 1 to either Arm A or Arm B in ratio 2:1 (18 participants in Arm A and 9 participants in Arm B).
Arm A participants will commence dosing with twice-daily oral 43.5 mg SENS-401 for 7 days prior to their scheduled cochlear implant surgery on Day 8 and up to 42 days from day of surgery inclusive.
Arm B participants will not receive any treatment other than their scheduled cochlear implant surgery.
- Conditions
- Hearing Loss
- Being tested
- SENS-401 (R-Azasetron Besylate)
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENS-401 (R-Azasetron Besylate)Drug
Patients will receive SENS-401 ((R)-azasetron besylate) for 7 days B.I.D. before cochlear implant surgery and during 6 weeks after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| A, Treatment arm | Experimental | Arm A: Participants scheduled for cochlear implantation and treated with oral 43.5 mg SENS-401 (R-Azasetron Besylate) twice daily for up to 49 days. Receives: Drug: SENS-401 (R-Azasetron Besylate) |
| B, Control arm | No intervention | Arm B: Participants scheduled for cochlear implantation and not treated with SENS-401 (R-Azasetron Besylate). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With SENS-401 Detected in Perilymph
A sample of perilymph was obtained from the round window during the cochlear implant surgery from Arm A participants only, after seven days of SENS-401. The percentage of participants with levels of SENS-401 in the perilymph above the Limit of Quantification was then calculated.
Measured: Day 8
Secondary outcomes (3)
SENS-401 Perilymph Concentration
SENS-401 perilymph concentration on day of cochlear implant surgery after seven days of SENS-401 (arm A only).
Measured: Day 8
SENS-401 Plasma Concentration
SENS-401 plasma concentration on day of cochlear implant surgery after seven days of SENS-401 (arm A only).
Measured: Day 8
Change of Hearing Threshold From Baseline in the Implanted Ear at Several Frequencies
Pure tone audiometry (PTA) in decibels (dB) is a behavioral, subjective hearing test used to assess an individual's hearing threshold levels and determine the degree of hearing loss. A decrease of hearing threshold is considered as an improvement and an increase as a deterioration of the audition.
PTA assessments were conducted on Day 1 after randomization (prior to the first dose of the study drug for Arm A), at the Day 49 visit, and at the end of the study (EOS) on Day 105 for all participants (Arms A and B).
The change in hearing threshold from baseline in the implanted ear was evaluated at 500 Hz and as an average across three frequencies (250, 500, and 750 Hz) using PTA.
Measured: Day 49 and Day 105
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start10 Aug 2022
- Primary completion18 Dec 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensorion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen O'Leary, MD, Principal investigator, Royal Victoria Eye and Ear Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258773
- Sponsor's protocol ID
- SENS-401-203
- Other IDs
- 2021-006615-28
- Status last verified
- Apr 2025
- First submitted
- 17 Feb 2022
- Last updated
- 23 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Presence of SENS-401 in the Perilymph After 7 Days of Repeated Oral Administration in Adult Participants Scheduled for Cochlear Implantation
- ClinicalTrials.gov ID
- NCT05258773
- Acronym / sponsor ID
- SENS-401-203
- Conditions
- Hearing Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- SensorionIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Posted 23 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to detect the presence of SENS-401 in the perilymph of participants undergoing cochlear implant surgery after 7 days of oral administration of SENS-401.
Detailed description
The study is a Phase IIa, open-label, randomized and controlled study investigating repeated twice-daily administration of oral SENS-401 in adult participants with moderately severe to profound hearing loss who have already agreed to undergo cochlear implant surgery justified by their hearing impairment.
After written informed consent is obtained and screening procedures completed, 27 eligible participants will be randomized on Day 1 to either Arm A or Arm B in ratio 2:1 (18 participants in Arm A and 9 participants in Arm B).
Arm A participants will commence dosing with twice-daily oral 43.5 mg SENS-401 for 7 days prior to their scheduled cochlear implant surgery on Day 8 and up to 42 days from day of surgery inclusive.
Arm B participants will not receive any treatment other than their scheduled cochlear implant surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, Treatment arm | Experimental | Drug: SENS-401 (R-Azasetron Besylate)Arm A: Participants scheduled for cochlear implantation and treated with oral 43.5 mg SENS-401 (R-Azasetron Besylate) twice daily for up to 49 days. |
| B, Control arm | No intervention | –Arm B: Participants scheduled for cochlear implantation and not treated with SENS-401 (R-Azasetron Besylate). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SENS-401 (R-Azasetron Besylate)Patients will receive SENS-401 ((R)-azasetron besylate) for 7 days B.I.D. before cochlear implant surgery and during 6 weeks after the surgery. | Drug | A, Treatment arm |
Primary outcome
Proportion of Participants With SENS-401 Detected in Perilymph
Time frame: Day 8
A sample of perilymph was obtained from the round window during the cochlear implant surgery from Arm A participants only, after seven days of SENS-401. The percentage of participants with levels of SENS-401 in the perilymph above the Limit of Quantification was then calculated.
3 secondary outcomes
SENS-401 Perilymph Concentration
Time frame: Day 8
SENS-401 Plasma Concentration
Time frame: Day 8
Change of Hearing Threshold From Baseline in the Implanted Ear at Several Frequencies
Time frame: Day 49 and Day 105
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Stephen O'Leary, MD principal investigator
Royal Victoria Eye and Ear Hospital
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SENS-401 (R-Azasetron Besylate) in people with Hearing Loss, run by Sensorion at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Yes. Results are posted in the registry (first posted 23 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Participants With SENS-401 Detected in Perilymph (time frame: Day 8). 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 23 Apr 2025.