Evaluation of the Presence of SENS-401 in the Perilymph

Phase 2

Completed

• Conditions: Hearing Loss
• Interventions: Drug: SENS-401 (R-Azasetron Besylate)

• Registration Number: NCT05258773
• Lead Sponsor: Sensorion

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 hearing loss who have already agreed to undergo cochlear implant surgery justified by their hearing impairment.

After written informed consent is obtained and screening procedures completed, 27 eligible participants will be randomized on Day 1 to either Arm A or Arm B in ratio 2:1 (18 participants in Arm A and 9 participants in Arm B).

Arm A participants will commence dosing with twice-daily oral 43.5 mg SENS-401 for 7 days prior to their scheduled cochlear implant surgery on Day 8 and up to 42 days from day of surgery inclusive.

Arm B participants will not receive any treatment other than their scheduled cochlear implant surgery.

Study Timeline

• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-28
• Study Start: 2022-08-10
• Primary Completion: 2023-12-18
• Study Completion: 2024-05-31
• Status Verified: 2025-04
• Results First Submitted: 2025-04-03
• Results First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Results First Posted: 2025-04-23
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A, Treatment arm	SENS-401 (R-Azasetron Besylate)	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With SENS-401 Detected in Perilymph	Day 8	A sample of perilymph was obtained from the round window during the cochlear implant surgery from Arm A participants only, after seven days of SENS-401. The percentage of participants with levels of SENS-401 in the perilymph above the Limit of Quantification was then calculated.

Secondary Outcome Measures

Name	Time	Method
SENS-401 Perilymph Concentration	Day 8	SENS-401 perilymph concentration on day of cochlear implant surgery after seven days of SENS-401 (arm A only).
SENS-401 Plasma Concentration	Day 8	SENS-401 plasma concentration on day of cochlear implant surgery after seven days of SENS-401 (arm A only).
Change of Hearing Threshold From Baseline in the Implanted Ear at Several Frequencies	Day 49 and Day 105	Pure tone audiometry (PTA) in decibels (dB) is a behavioral, subjective hearing test used to assess an individual's hearing threshold levels and determine the degree of hearing loss. A decrease of hearing threshold is considered as an improvement and an increase as a deterioration of the audition.; PTA assessments were conducted on Day 1 after randomization (prior to the first dose of the study drug for Arm A), at the Day 49 visit, and at the end of the study (EOS) on Day 105 for all participants (Arms A and B).; The change in hearing threshold from baseline in the implanted ear was evaluated at 500 Hz and as an average across three frequencies (250, 500, and 750 Hz) using PTA.

Trial Locations

Locations (7)

Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin; 🇫🇷 Bordeaux, France

Centre Hospitalier Universitaire de Clermont-Ferrand - Hôpital Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Centre Hospitalier Universitaire de Lille Hôpital Roger Salengro; 🇫🇷 Lille, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Groupe Hospitalier La Pitié-Salpétrière; 🇫🇷 Paris, France

Centre Hospitalier Universitaire de Toulouse, Hôpital Purpan; 🇫🇷 Toulouse, France

Royal Victorian Eye and Ear Hospital; 🇦🇺 Melbourne, Australia