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A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome
NCT05419492 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG ETX101
Study Locations (8)
Other
- The Royal Children's Hospital — Melbourne
- Queen Elizabeth Hospital — Glasgow
- Great Ormond Street Hospital — London
California
- UCSF Benioff Children's Hospitals — San Francisco
Florida
- Nicklaus Children's Hospital — Miami
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
Oregon
- Oregon Health and Science University (OSHU) — Portland
Texas
- Cook Children's Medical Center — Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2024-05-14 |
| Est. Completion | 2033-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05419492
The ClinicalTrials.gov registry entry for NCT05419492 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Encoded Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Dravet Syndrome appearing as the primary indexed condition, and to 1 intervention — of which ETX101 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05419492 reports 8 study locations spanning 6 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05419492 about?
NCT05419492 is a clinical study titled "A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome". 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-esc...
What is the current status of trial NCT05419492?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2024-05-14. Estimated completion is 2033-01.
What conditions does trial NCT05419492 study?
This clinical trial studies the following conditions: Dravet Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05419492?
The interventions under investigation include: ETX101 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05419492?
This trial is sponsored by Encoded Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05419492 being conducted?
This trial has 8 study locations across California, Florida, Illinois, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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