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A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations — AUDIOGENE  

Hearing Loss, Sensorineural Clinical Trial

Official title:
A Phase I/II, Open-ended, Adaptative, Open Label Dose Escalation and Expansion Clinical Trial to Evaluate the Efficacy and Safety of Unilateral Intracochlear Injection of SENS-501 Using an Injection System in Children With Severe to Profound Hearing Loss Due to Otoferlin Gene Mutations

Clinical Trial Summary

This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.

Clinical Trial Description

It is a multicenter, adaptive open-label, non-randomized, dose-escalation, and expansion study to assess safety, tolerability, and efficacy following intracochlear administration of SENS-501. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06370351
Study type Interventional
Source Sensorion
Contact Lionel HOVSEPIAN, MD
Phone +33786311376
Email lionel.hovsepian@sensorion-pharma.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date April 30, 2024
Completion date April 2031
View Details
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