Actively Recruiting
A Phase I/II Clinical Trial with SENS-501 in Children Suffering from Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations
Led by Sensorion · Updated on 2024-09-26
12
Participants Needed
2
Research Sites
366 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I/II Clinical Trial with SENS-501 in Children Suffering from Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged between 6 and 31 months at the time of inclusion
- Severe to profound hearing loss confirmed by auditory brainstem response (ABR)
- Biallelic mutation in the Otoferlin gene
- Presence of otoacoustic emissions (OAEs)
- Normal cochlea and internal auditory canals documented
- Intact vestibular function
You will not qualify if you...
- History of any chronic, acute, or major disease making participation unsafe or risky
- Previous dosing in a gene therapy clinical trial
- Current or prior cochlear implant
- Contraindications to surgery or anesthesia or history of long-term ototoxic therapy
- Participation in another interventional clinical trial
- Any condition that may affect safety, compliance, or study evaluation
- Expected noncompliance with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Childrens Hospital Westmead
Westmead, Australia, NSW 2145
Actively Recruiting
2
Hopital Necker Enfants Malades
Paris, France, 75015
Actively Recruiting
Research Team
L
Lionel HOVSEPIAN, MD
CONTACT
G
Géraldine HONNET, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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