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A Multicenter, Open Label, Randomized, Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, and Efficacy of a Single Intrathecal Administration of TSHA-102, an AAV9-Delivered Gene Therapy, for the Treatment of Pediatric Females With Rett Syndrome

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Trial Profile

A Multicenter, Open Label, Randomized, Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, and Efficacy of a Single Intrathecal Administration of TSHA-102, an AAV9-Delivered Gene Therapy, for the Treatment of Pediatric Females With Rett Syndrome

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Dec 2025

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At a glance

  • Drugs TSHA 102 (Primary)
  • Indications Rett syndrome
  • Focus Adverse reactions; Registrational
  • Acronyms REVEAL; REVEAL Pediatric Study
  • Sponsors Taysha Gene Therapies

Most Recent Events

  • 04 Nov 2025 According to a Taysha Gene Therapies media release, dosing of the first patient in the REVEAL pivotal trial is scheduled for the fourth quarter of 2025, with enrollment of additional patients expected to continue at multiple sites during the quarter.
  • 04 Nov 2025 According to a Taysha Gene Therapies media release, update on longer-term safety and efficacy data from Part A of REVEAL Phase 1/2 trials expected in the first half of 2026.
  • 15 Oct 2025 Status changed from recruiting to active, no longer recruiting.

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