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Safety and Preliminary Efficacy of TSHA-102 Gene Therapy in Pediatric Females Aged >2 to <4 Years With Rett Syndrome

Study acronym: ASPIRE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing
    • Enrollment increased: 3 → 4 participants
    • Study sites: 1 to 3
    v3
  2. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2026 to May 8, 2026
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 primary objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of a single intrathecal (IT) dose of TSHA-102 in pediatric females with typical Rett syndrome.
Trial Details
NCT Number NCT07480564
Lead Sponsor Taysha Gene Therapies, Inc.
Conditions
(from sponsor)		 Rett Syndrome
Related terms Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Genetic Diseases, X-Linked, Intellectual Disability, Nervous System Diseases, Neurodevelopmental Disorders, Neurologic Manifestations, Pathologic Processes, Rett Syndrome, X-Linked Intellectual Disability
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov