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NCT05419492 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome
A Phase 1 study of Dravet Syndrome, sponsored by Encoded Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 8
- Study locations
NCT05419492 is a Phase 1 study of Dravet Syndrome that is actively recruiting participants, run by Encoded Therapeutics. The registered enrollment target is 47 participants, below the 106-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (56% lower). The trial reports 8 study locations across 6 states.
The verdict
NCT05419492, a Phase 1 study of Dravet Syndrome, is actively recruiting participants, sponsored by Encoded Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 8
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 106-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (56% lower). The listed sponsor is Encoded Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
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.
NCT05419492 reports 8 study locations spanning 6 distinct geographic areas - top geographies include Other, California, Florida.
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.
What interventions are being tested in trial NCT05419492?
The interventions under investigation include: ETX101 (DRUG).
Who is sponsoring clinical trial NCT05419492?
This trial is sponsored by Encoded Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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