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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 2
Healthy Volunteers: f
View:

• Children (male or female) ≥ 6 to ≤ 31 months at the time of inclusion

• Severe to profound hearing loss assessed by auditory brainstem response (ABR)

• Biallelic mutation in the Otoferlin gene

• Presence of Otoacoustic emissions (OAEs)

• Documented normal cochlea and internal auditory canals

• Patients with intact vestibular function

Locations
Other Locations
Australia
Childrens Hospital Westmead
RECRUITING
Westmead
France
Hopital Necker Enfants Malades
RECRUITING
Paris
Contact Information
Primary
Lionel HOVSEPIAN, MD
lionel.hovsepian@sensorion-pharma.com
+33 7 86 31 13 76
Backup
Géraldine HONNET, MD
geraldine.honnet@sensorion-pharma.com
Time Frame
Start Date: 2024-06-21
Estimated Completion Date: 2031-07
Participants
Target number of participants: 12
Treatments
Experimental: Dose escalation - Low dose group
Intracochlear administration of a Low dose of SENS-501 in one ear, with a dedicated administration system
Experimental: Dose escalation - High dose group
Intracochlear administration of a High dose of SENS-501 in one ear, with a dedicated administration system
Experimental: Dose expansion group
Intracochlear administration of SENS-501 in one ear, with a dedicated administration system, at the dose recommended following the Dose escalation phase
Related Therapeutic Areas
Hearing Loss
Sponsors
Leads: Sensorion

This content was sourced from clinicaltrials.gov

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