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An Open-label Phase 1/2/3 Study Consisting of a Phase 1/2 Safety and Dose-escalation and Phase 3 Dose-expansion Study to Evaluate Safety and Efficacy of a Single Intrathecal Administration of TSHA-102, an AAV9-Delivered Gene Therapy in Females With Rett Syndrome

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Trial Profile

An Open-label Phase 1/2/3 Study Consisting of a Phase 1/2 Safety and Dose-escalation and Phase 3 Dose-expansion Study to Evaluate Safety and Efficacy of a Single Intrathecal Administration of TSHA-102, an AAV9-Delivered Gene Therapy in Females With Rett Syndrome

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 01 Jan 2026

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At a glance

  • Drugs TSHA 102 (Primary)
  • Indications Rett syndrome
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Acronyms REVEAL; REVEAL Adult Study
  • Sponsors Taysha Gene Therapies

Most Recent Events

  • 21 Nov 2025 Primary end point are replaced by new primary safety end-point for part A and primary efficacy end-point for part B. Number of treatment arms are increased from 2 to 3 by the addition of Experimental: Part B Pivotal Cohort. Age limits are changed for inclusion criteria.
  • 21 Nov 2025 Planned End Date changed from 5 Jan 2032 to 1 Jun 2031.
  • 21 Nov 2025 Planned primary completion date changed from 2 Nov 2028 to 1 Jun 2031.

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