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A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome (Australia Only)

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Jun 2030 to Sep 2030
    • Site details revised
    v5
  2. Primary and study completion dates: Dec 2029 to Jun 2030
    • Study arms: 3 to 4
    v4
  3. Start date changed from estimate of Mar 2024 to Feb 28, 2024
    • Secondary endpoints revised (2)
    • Study arms: 2 to 3
    • Eligibility criteria shortened, about 1 word
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
WAYFINDER is a Phase 1/2 study in Australia to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet syndrome aged 6 to \<84 months. The study follows an open-label, dose-escalation design.
Trial Details
NCT Number NCT06112275
Lead Sponsor Encoded Therapeutics
Conditions
(from sponsor)		 Dravet Syndrome
Related terms Epilepsies, Myoclonic, Generalized Epilepsy With Febrile Seizures Plus, Type 2
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov