Phase 2
N=28
Evaluation of the Presence of SENS-401 in the Perilymph
Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT05258773 ↗Enrolled (actual)
28
Serious AEs
7.4%
Results posted
Apr 2025
Primary outcome: Primary: Proportion of Participants With SENS-401 Detected in Perilymph — 15; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SENS-401 (R-Azasetron Besylate) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sensorion
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With SENS-401 Detected in Perilymph |
15; 0 | — |
| SECONDARY SENS-401 Perilymph Concentration |
45.8009 | — |
| SECONDARY SENS-401 Plasma Concentration |
59.6244 | — |
| SECONDARY Change of Hearing Threshold From Baseline in the Implanted Ear at Several Frequencies |
19.7; 30.6; 16.25; 30.65; 25.6; 34.5 | 0.1406 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05258773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.