Frontlight ResearchEarly access
CompletedPhase 2
Evaluation of the Presence of SENS-401 in the Perilymph
Key facts
- Who runs it
- Sensorion
- Where
- Australia and France7 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 28 people enrolled
- Started
- 10 Aug 2022
- Ended
- 31 May 2024
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- SENS-401 (R-Azasetron Besylate)
- Record updated
- 23 April 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Other 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
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- A, Treatment armTreatment being tested
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.
Treatment: SENS-401 (R-Azasetron Besylate)
- B, Control armNo study treatment, for comparison
Arm B: Participants scheduled for cochlear implantation and not treated with SENS-401 (R-Azasetron Besylate).
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 23 April 2025