Status:
COMPLETED
Evaluation of the Presence of SENS-401 in the Perilymph
Lead Sponsor:
Sensorion
Conditions:
Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
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 hearin...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
August 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05258773
Start Date
August 10 2022
End Date
May 31 2024
Last Update
April 23 2025
Active Locations (7)
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1
Royal Victorian Eye and Ear Hospital
Melbourne, Australia
2
Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin
Bordeaux, France
3
Centre Hospitalier Universitaire de Clermont-Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand, France
4
Centre Hospitalier Universitaire de Lille Hôpital Roger Salengro
Lille, France