Evaluation of the Presence of SENS-401 in the Perilymph

Sensorion28 enrolled

Overview

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 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Hearing Loss

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Main 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

Locations (7)

Royal Victorian Eye and Ear Hospital

Melbourne, Australia

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

Outcomes

Primary Outcomes

Proportion of Participants With SENS-401 Detected in Perilymph

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.

Time frame: Day 8

Secondary Outcomes

SENS-401 Perilymph Concentration

SENS-401 perilymph concentration on day of cochlear implant surgery after seven days of SENS-401 (arm A only).

Time frame: Day 8

SENS-401 Plasma Concentration

SENS-401 plasma concentration on day of cochlear implant surgery after seven days of SENS-401 (arm A only).

Time frame: Day 8

Change of Hearing Threshold From Baseline in the Implanted Ear at Several Frequencies

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.

Time frame: Day 49 and Day 105

Data from ClinicalTrials.gov

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