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Safety and Efficacy of TSHA-102 in Pediatric Females With Rett Syndrome (REVEAL Pediatric Study)

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 20 to confirmed 6
    • Study sites: 10 to 5
    v9
  2. Site contacts updated at 8 of 10 sitesv8
  3. Study sites revised (10)v7
  4. Phase: Phase 1 to Phase 1/2
    • Enrollment target: 6 to 20
    • Site details revised at 1 of 10 sites
    v6
  5. Site contacts updated at 1 of 10 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 9 to 10v4
  2. Study sites: 8 to 9v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 8
    • Start date changed from estimate of Jan 22, 2024 to Dec 12, 2023
    • Secondary endpoints: details revised at 6 of 6 entries
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The REVEAL Pediatric Study is a multi-center, Phase 1/2 open-label, dose-escalation and dose-expansion study of TSHA-102, an investigational gene therapy, in pediatric females with Rett Syndrome. The safety, tolerability, and preliminary efficacy of two dose levels will be evaluated. The study duration is up to 6 years.
Trial Details
NCT Number NCT06152237
Lead Sponsor Taysha Gene Therapies, Inc.
Conditions
(from sponsor)		 Rett Syndrome
Related terms Neurodevelopmental Disorders, Rett Syndrome
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov