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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

Study acronym: AUDIOGENE
StatusActive, Not Recruiting
PhasePhase 1/2
SponsorSensorion
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 1 to 2
    • Primary completion date: Apr 2027 to Jul 2027
    • Study completion date: Apr 2031 to Jul 2031
    • Start date changed from estimate of Apr 30, 2024 to Jun 21, 2024
    • Secondary endpoints: details revised at 1 of 6 entries
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sensorion
4 trials monitored
See all monitored trials
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.
Trial Details
NCT Number NCT06370351
Lead Sponsor Sensorion
Conditions
(from sponsor)		 OTOF Gene Mutation, DFNB9, Congenital Deafness, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases, Deafness, Hearing Loss, Sensorineural
Related terms Deafness, Deafness, Autosomal Recessive 9, Ear Diseases, Hearing Disorders, Hearing Loss, Hearing Loss, Sensorineural, Otorhinolaryngologic Diseases
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov