Evaluation of the Presence of SENS-401 in the Perilymph

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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Drug: SENS-401 (R-Azasetron Besylate)

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia
    • Royal Victorian Eye and Ear Hospital
• France
  • Bordeaux, France
    • Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin
  • Clermont-Ferrand, France
    • Centre Hospitalier Universitaire de Clermont-Ferrand - Hôpital Gabriel Montpied
  • Lille, France
    • Centre Hospitalier Universitaire de Lille Hôpital Roger Salengro
  • Lyon, France
    • Hôpital Edouard Herriot
  • Paris, France
    • Groupe Hospitalier La Pitie-Salpetriere
  • Toulouse, France
    • Centre Hospitalier Universitaire de Toulouse, Hôpital Purpan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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.
No Intervention: B, Control arm; Arm B: Participants scheduled for cochlear implantation and not treated with SENS-401 (R-Azasetron Besylate).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SENS-401 Perilymph Concentration	SENS-401 perilymph concentration on day of cochlear implant surgery after seven days of SENS-401 (arm A only).	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).	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.	Day 49 and Day 105

Collaborators and Investigators

• Sponsor: Sensorion
• Investigators: Principal Investigator: Stephen O'Leary, MD, Royal Victoria Eye and Ear Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Neurotransmitter Agents; Serotonin Antagonists; Serotonin Agents; Azasetron
• Other Study ID Numbers: SENS-401-203; 2021-006615-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes