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NCT07019922 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety
A Phase 3 study of Epileptic Encephalopathy and SCN2A Encephalopathy, sponsored by Praxis Precision Medicines.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT07019922: Recruiting Phase 3 study of Epileptic Encephalopathy and SCN2A Encephalopathy, sponsored by Praxis Precision Medicines.
NCT07019922 is a Phase 3 study of Epileptic Encephalopathy and SCN2A Encephalopathy that is actively recruiting participants, run by Praxis Precision Medicines. The registered enrollment target is 50 participants, below the 1,811-participant average among 3 other Epileptic Encephalopathy trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07019922, a Phase 3 study of Epileptic Encephalopathy and SCN2A Encephalopathy, is actively recruiting participants, sponsored by Praxis Precision Medicines.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 2
- Study locations
Study Summary
A Randomized, Multi-Center, Double-Blind, Sham-Procedure-Controlled Clinical Trial to Investigate the Efficacy and Safety of Elsunersen in Pediatric Participants with Early Onset SCN2A Developmental and Epileptic Encephalopathy
Primary Outcome
Median percent change in monthly (28 days) motor seizure frequency from baseline to treatment after 24 weeks
Conditions Studied
Interventions
- DRUG 1mg elsunersen
- PROCEDURE sham procedure
- DRUG 0.5mg elsunersen
Study Locations (2)
California
- Praxis Research Site - San Diego
Illinois
- Praxis Research Site - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-08-13 |
| Est. Completion | 2028-12 |
| Phase | Phase 3 |
What NCT07019922 shows while recruiting
NCT07019922 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,811-participant average among 3 other Epileptic Encephalopathy trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Epileptic Encephalopathy appearing as the primary indexed condition, and to 3 interventions - of which 1mg elsunersen is the first listed.
NCT07019922 reports a single indexed study location in California, Illinois.
Frequently Asked Questions
What is clinical trial NCT07019922 about?
NCT07019922 is a clinical study titled "A Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety". A Randomized, Multi-Center, Double-Blind, Sham-Procedure-Controlled Clinical Trial to Investigate the Efficacy and Safety of Elsunersen in Pediatric Participants with Early Onset SCN2A Developmental and Epileptic Encephalopathy
What is the current status of trial NCT07019922?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2025-08-13. Estimated completion is 2028-12.
What conditions does trial NCT07019922 study?
This clinical trial studies the following conditions: Epileptic Encephalopathy, SCN2A Encephalopathy.
What interventions are being tested in trial NCT07019922?
The interventions under investigation include: 1mg elsunersen (DRUG), sham procedure (PROCEDURE), 0.5mg elsunersen (DRUG).
Who is sponsoring clinical trial NCT07019922?
This trial is sponsored by Praxis Precision Medicines, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07019922 being conducted?
This trial has 2 study locations across California, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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