At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 28 enrolled
Drug / intervention
SENS-401 (R-Azasetron Besylate)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating SENS-401 (R-Azasetron Besylate) for Hearing Loss. Completed, enrolled 28 participants across 7 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHearing Loss
CountriesAustralia, France
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedFeb 2022
Enrollment StartAug 2022
Primary CompletionDec 2023
Study CompletionMay 2024
TodayJul 2026
First PostedFeb 28, 2022
Enrollment StartAug 10, 2022
Primary CompletionDec 18, 2023
Study CompletionMay 31, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.3 years ago
Interventions
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.