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Evaluation of the Presence of SENS-401 in the Perilymph

Primary Purpose

Hearing Loss

Status
Recruiting
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
SENS-401 (R-Azasetron Besylate)
Sponsored by
Sensorion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hearing Loss

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

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

  1. Adults aged 18 to 75 years;
  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

Sites / Locations

  • Royal Victorian Eye and Ear HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A, Treatment arm

B, Control arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

SENS-401 perilymph detection percentage
Percentage of participants from Arm A with levels of SENS-401 in the perilymph above the Limit of Quantification on day of cochlear implant surgery after seven days of SENS-401.

Secondary Outcome Measures

SENS-401 perilymph concentration
SENS-401 perilymph concentration on day of cochlear implant surgery after seven days of SENS-401.
SENS-401 plasma concentration
SENS-401 plasma concentration on day of cochlear implant surgery after seven days of SENS-401.
Change of hearing threshold from baseline in the implanted ear at several frequencies
Change of hearing threshold from baseline in the implanted ear at several frequencies

Full Information

First Posted
February 17, 2022
Last Updated
October 31, 2022
Sponsor
Sensorion
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1. Study Identification

Unique Protocol Identification Number
NCT05258773
Brief Title
Evaluation of the Presence of SENS-401 in the Perilymph
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sensorion

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A, Treatment arm
Arm Type
Experimental
Arm Description
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.
Arm Title
B, Control arm
Arm Type
No Intervention
Arm Description
Arm B: Participants scheduled for cochlear implants and not treated with SENS-401 (R-Azasetron Besylate).
Intervention Type
Drug
Intervention Name(s)
SENS-401 (R-Azasetron Besylate)
Intervention Description
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.
Primary Outcome Measure Information:
Title
SENS-401 perilymph detection percentage
Description
Percentage of participants from Arm A with levels of SENS-401 in the perilymph above the Limit of Quantification on day of cochlear implant surgery after seven days of SENS-401.
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
SENS-401 perilymph concentration
Description
SENS-401 perilymph concentration on day of cochlear implant surgery after seven days of SENS-401.
Time Frame
Day 7
Title
SENS-401 plasma concentration
Description
SENS-401 plasma concentration on day of cochlear implant surgery after seven days of SENS-401.
Time Frame
Day 7
Title
Change of hearing threshold from baseline in the implanted ear at several frequencies
Description
Change of hearing threshold from baseline in the implanted ear at several frequencies
Time Frame
Day 105

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Potential participants must fulfil all of the following main inclusion criteria to be eligible for the study: Adults aged 18 to 75 years; 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; Main Exclusion Criteria: Individuals will be excluded from the study if any of the following main exclusion criteria apply: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaux Lemoine, PharmD
Phone
+33 (0) 7 86 67 65 42
Email
margaux.lemoine@sensorion-pharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Géraldine Honnet, MD
Email
geraldine.honnet@sensorion-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen O'Leary, MD
Organizational Affiliation
Royal Victoria Eye and Ear Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Victorian Eye and Ear Hospital
City
Melbourne
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen O'Leary, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Presence of SENS-401 in the Perilymph

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