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A Phase 1/2/3 Study of TSHA-102 Gene Therapy in Females With Rett Syndrome (REVEAL Pivotal Study)

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment increased: 15 → 17 participants
    • Trial sites expanded: 6 → 9 locations
    v13
  2. Study sites: 5 to 6v12
  3. Phase: Phase 1/2 to Phase 3v11 Show 10 more changesShow less
    • Primary completion date: Nov 2, 2028 to Jun 2031
    • Primary endpoints: 4 to 2
    • Enrollment target: 18 to 15
    • Study sites: 6 to 5
    • Study completion date: Jan 5, 2032 to Jun 2031
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints shortened, about 57 words
    • Study description expanded, about 125 words
    • Study title revised
    • Study arms: 2 to 3
  4. Primary completion date: Jan 31, 2025 to Nov 2, 2028
    • Site contacts updated at 6 of 6 sites
    v10
  5. Study sites revised (6)
    • Study title expanded, about 2 words
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 2 to 6
    • Primary completion date: Nov 8, 2024 to Jan 31, 2025
    v8
  2. Site details revised at 1 of 2 sitesv7
  3. Study sites: 1 to 2v6
  4. Enrollment target: 12 to 18
    • Primary completion date: Nov 8, 2023 to Nov 8, 2024
    • Eligibility criteria shortened, about 19 words
    v5
  5. Start date changed from estimate of Nov 8, 2022 to Mar 6, 2023v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary completion date: Oct 17, 2023 to Nov 8, 2023
    • Start date: Oct 28, 2022 to Nov 8, 2022
    v3
  7. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 primary objectives of this study are to evaluate the safety of a single intrathecal (IT) dose of TSHA-102 in females with typical Rett syndrome, to select the TSHA-102 dose with the best benefit/risk profile based on the totality of safety and efficacy data and to evaluate the efficacy and safety of TSHA-102 at the selected dose.
Trial Details
NCT Number NCT05606614
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 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov