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Evaluation of the Presence of SENS-401 in the Perilymph

NCT05258773 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-04-23

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Sensorion

    lead INDUSTRY

Principal Investigators

  • Stephen O'Leary, MD · Royal Victoria Eye and Ear Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-10
Primary Completion
2023-12-18
Completion
2024-05-31
FDA Drug
Yes

Countries

  • Australia
  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05258773 on ClinicalTrials.gov