Evaluation of the Presence of SENS-401 in the Perilymph

Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05258773
• Other study ID #: SENS-401-203
• Secondary ID: 2021-006615-28
• Status: Completed
• Phase: Phase 2
• Start date: August 10, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2024
• Source: Sensorion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 31, 2024
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
Australia	Royal Victorian Eye and Ear Hospital	Melbourne

Sponsors (1)

Lead Sponsor	Collaborator
Sensorion

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 7
Secondary	SENS-401 perilymph concentration	SENS-401 perilymph concentration on day of cochlear implant surgery after seven days of SENS-401.	Day 7
Secondary	SENS-401 plasma concentration	SENS-401 plasma concentration on day of cochlear implant surgery after seven days of SENS-401.	Day 7
Secondary	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	Day 105