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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

NCT06370351 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-09-26

No results posted yet for this study

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.

Conditions

  • OTOF Gene Mutation
  • DFNB9
  • Congenital Deafness
  • Hearing Disorders
  • Ear Diseases
  • Otorhinolaryngologic Diseases
  • Deafness
  • Hearing Loss, Sensorineural

Interventions

COMBINATION_PRODUCT

SENS-501 administration

Administration of SENS-501 with a dedicated administration system

Sponsors & Collaborators

  • Sensorion

    lead INDUSTRY

Principal Investigators

  • Natalie LOUNDON, Pr · Hopital Necker Enfants Malades

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
6 Months
Max Age
31 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-21
Primary Completion
2027-07-31
Completion
2031-07-31

Countries

  • Australia
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06370351 on ClinicalTrials.gov