Evaluation of the Presence of SENS-401 in the Perilymph

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-10

Study Completion Date

2024-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SENS-401 (R-Azasetron Besylate)

Intervention Type 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.

B, Control arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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;

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No