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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

Study acronym: UK Only
StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary endpoints: 2 to 1
    • Secondary endpoints: 2 to 10
    v9
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 4 to confirmed 5
    • Primary and study completion dates: Sep 2030 to Oct 2030
    • Site details revised at 3 of 3 sites
    v8
  3. Primary and study completion dates: Dec 2029 to Sep 2030
    • Study arms: 3 to 4
    v7
  4. Site details revised at 1 of 3 sitesv6
  5. Start date: Apr 15, 2024 to May 9, 2024
    • Study arms: 2 to 3
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date changed from estimate of Apr 2024 to Apr 15, 2024
    • Site details revised at 1 of 3 sites
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2024 to Apr 2024
    • Site details revised at 3 of 3 sites
    v3
  3. Study title shortened, about 1 wordv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
EXPEDITION is a Phase 1/2 study in the UK to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet Syndrome aged 6 to \< 48 months. The study follows and open-label, dose-escalation design.
Trial Details
NCT Number NCT06283212
Lead Sponsor Encoded Therapeutics
Conditions
(from sponsor)		 Dravet Syndrome
Related terms Epilepsies, Myoclonic
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov