NCT05258773

Evaluation of the Presence of SENS-401 in the Perilymph

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Sensorion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-10
• Primary completion: 2023-12-18
• Completion: 2024-05-31
• First posted: 2022-02-28
• Last updated: 2025-04-23
• Results posted: 2025-04-23

Locations

7 sites across 2 countries: Australia, France

Regulatory

• FDA-regulated drug study