Clinical Trial

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

Active, Not Recruiting Phase 1/2
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Summary
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2023-11-21; most recent amendment 2025-10-10.
Status change: Recruiting → Active, Not Recruiting 2025-10-10
Status change: Not Yet Recruiting → Recruiting 2023-12-19
Trial Details
NCT Number NCT06152237
Lead Sponsor Taysha Gene Therapies, Inc.
Conditions Rett Syndrome
Enrollment 6 participants
Start Date 2023-12-12
Primary Completion 2028-11-02 (estimated)
Study Completion 2031-11-02 (estimated)
Updated on ClinicalTrials.gov 2025-10-15