NCT05258773

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2022

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 23, 2025

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

1.4 years

First QC Date

February 17, 2022

Results QC Date

April 3, 2025

Last Update Submit

April 3, 2025

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • SENS-401 Perilymph Concentration

    Day 8

  • SENS-401 Plasma Concentration

    Day 8

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

    Day 49 and Day 105

Study Arms (2)

A, Treatment arm

EXPERIMENTAL

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)

B, Control arm

NO INTERVENTION

Arm B: Participants scheduled for cochlear implantation and not treated with SENS-401 (R-Azasetron Besylate).

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.

A, Treatment arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Royal Victorian Eye and Ear Hospital

Melbourne, Australia

Location

Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin

Bordeaux, France

Location

Centre Hospitalier Universitaire de Clermont-Ferrand - Hôpital Gabriel Montpied

Clermont-Ferrand, France

Location

Centre Hospitalier Universitaire de Lille Hôpital Roger Salengro

Lille, France

Location

Hôpital Edouard Herriot

Lyon, France

Location

Groupe Hospitalier La Pitié-Salpétrière

Paris, France

Location

Centre Hospitalier Universitaire de Toulouse, Hôpital Purpan

Toulouse, France

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

SENS-401

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Chief Medical Officer
Organization
Sensorion
contact@sensorion-pharma.com
+33 4 67 20 77 30

Study Officials

  • Stephen O'Leary, MD

    Royal Victoria Eye and Ear Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2022

First Posted

February 28, 2022

Study Start

August 10, 2022

Primary Completion

December 18, 2023

Study Completion

May 31, 2024

Last Updated

April 23, 2025

Results First Posted

April 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)AU(1)