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A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome

Study acronym: ENDEAVOR
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 13 words
    • Site details revised at 10 of 14 sites
  2. Site contacts updated at 1 of 14 sitesv26
  3. Site contacts updated at 1 of 14 sitesv25
  4. Site details revised at 1 of 14 sitesv24
  5. Site contacts updated at 1 of 14 sitesv23
Show 21 earlier versionsHide 21 earlier versions
  1. Study sites: 13 to 14v22
  2. Site details revised at 1 of 13 sitesv21
  3. Site details revised at 1 of 13 sitesv20
  4. Site details revised at 1 of 13 sitesv19
  5. Site details revised at 1 of 13 sitesv18
  6. Study sites: 12 to 13v17
  7. Study sites: 11 to 12v16
  8. Study sites: 10 to 11v15
  9. Site details revised at 1 of 10 sitesv14
  10. Study sites: 9 to 10v13
  11. Study sites: 8 to 9v12
  12. Site details revised at 1 of 8 sitesv11
  13. Study sites: 7 to 8v10
  14. Site details revised at 1 of 7 sitesv9
  15. Enrollment target: 22 to 47v8 Show 6 more changesShow less
    • Primary completion date: Apr 2027 to Jan 2028
    • Primary endpoints: 2 to 1
    • Study sites: 3 to 7
    • Study completion date: Apr 2031 to Jan 2033
    • Eligibility criteria shortened, about 12 words
    • Secondary endpoints: 3 to 10
  16. Site details revised at 1 of 3 sitesv7
  17. Site contacts updated at 3 of 3 sitesv6
  18. Study sites: 2 to 3
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: 2 to 3
    v5
  19. Start date changed from estimate of Apr 2024 to May 14, 2024
    • Site details revised at 1 of 2 sites
    • Eligibility criteria shortened, about 1 word
    v4
  20. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: May 2027 to Apr 2027
    • Study completion date: May 2031 to Apr 2031
    • Start date: May 2024 to Apr 2024
    • Site details revised at 2 of 2 sites
  21. Primary completion date: Feb 2026 to May 2027v2 Show 5 more changesShow less
    • Start date: Dec 2022 to May 2024
    • Primary endpoints: 3 to 2
    • Study sites: 0 to 2
    • Study completion date: Oct 2029 to May 2031
    • Secondary endpoints revised (2)
  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.
ENDEAVOR is a Phase 1/2, 2-part, multicenter study to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet syndrome aged ≥6 to \<36 months (Part 1A), aged ≥48 months to \<18 years (Part 1B), and aged ≥6 to \<48 months (Part 2). Part 1A follows an open-label, dose-escalation design, Part 1B follows an open-label design, and Part 2 is a randomized, double-blind, sham delayed-treatment control study.
Trial Details
NCT Number NCT05419492
Lead Sponsor Encoded Therapeutics
Conditions
(from sponsor)		 Dravet Syndrome
Related terms Epilepsies, Myoclonic, Generalized Epilepsy With Febrile Seizures Plus, Type 2
Enrollment 47 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov