Evaluation of the Presence of SENS-401 in the Perilymph

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Hearing Loss

Clinical Trial Details

NCT number	NCT05258773
Study type	Interventional
Source	Sensorion
Contact
Status	Completed
Phase	Phase 2
Start date	August 10, 2022
Completion date	May 31, 2024

View Details

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