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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05258773




Registration number
NCT05258773
Ethics application status
Date submitted
17/02/2022
Date registered
28/02/2022

Titles & IDs
Public title
Evaluation of the Presence of SENS-401 in the Perilymph
Scientific 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
Secondary ID [1] 0 0
2021-006615-28
Secondary ID [2] 0 0
SENS-401-203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SENS-401 (R-Azasetron Besylate)

Experimental: A, Treatment arm - 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.

No intervention: B, Control arm - Arm B: Participants scheduled for cochlear implants and not treated with SENS-401 (R-Azasetron Besylate).


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
SENS-401 perilymph detection percentage
Timepoint [1] 0 0
Day 7
Secondary outcome [1] 0 0
SENS-401 perilymph concentration
Timepoint [1] 0 0
Day 7
Secondary outcome [2] 0 0
SENS-401 plasma concentration
Timepoint [2] 0 0
Day 7
Secondary outcome [3] 0 0
Change of hearing threshold from baseline in the implanted ear at several frequencies
Timepoint [3] 0 0
Day 105

Eligibility
Key inclusion criteria
Main

Potential participants must fulfil all of the following main inclusion criteria to be eligible for the study:

1. Adults aged from 18 years and older;
2. 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;
3. Signed and dated written informed consent;

Main
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be excluded from the study if any of the following main exclusion criteria apply:

1. Moderate to severe renal impairment defined by a creatinine clearance = 60 ml/min
2. 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
3. Unable or unwilling to comply with the protocol requirements
4. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2024
Sample size
Target
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Victorian Eye and Ear Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sensorion
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen O'Leary, MD
Address 0 0
Royal Victoria Eye and Ear Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05258773