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Natural History in Children up to 16 Years With Mild to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes

Study acronym: Otoconex
StatusRecruiting
PhaseNot specified
SponsorSensorion
Started
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Record History

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  1. Primary and study completion pushed from Nov 18, 2028 to Jun 2031v7
  2. Secondary endpoints: details revised at 1 of 2 entriesv6
  3. Primary and study completion dates: Nov 18, 2026 to Nov 18, 2028v5 Show 4 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description revised
    • Study title revised
  4. Study Identification, Study Status, Conditionsv4
  5. Start date: Oct 13, 2022 to Nov 18, 2022
    • Primary and study completion dates: Oct 13, 2026 to Nov 18, 2026
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 31, 2022 to Oct 13, 2022
    • Study sites: 0 to 1
    • Primary and study completion dates: May 31, 2026 to Oct 13, 2026
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
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The purpose of this study is to follow the natural history of non-syndromic hearing loss caused by mutations in two genes (GJB2 or OTOF) in children up to 16 years of age.
Trial Details
NCT Number NCT05402813
Lead Sponsor Sensorion
Conditions
(from sponsor)		 Sensorineural Hearing Loss, Bilateral, AUNB1, DFNB1A, Congenital Deafness, DFNB9, OTOF Gene Mutation, GJB2 Gene Mutation
Related terms Deafness, Autosomal Recessive 1A, Hearing Loss, Sensorineural
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov