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A Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety

StatusRecruiting
PhasePhase 3
Started2025-08-13
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 2026 → Dec 2026
See other at-risk trials from Praxis Precision Medicines

Amendment history

2026-07-31
Study Status v6
Primary completion pushed: 2026-06 → 2026-12
2026-05-22
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Contacts/Locations v5
Enrollment reduced: 50 → 40 participants
Trial arms changed: 4 → 3
Trial sites expanded: 4 → 10 locations
Interventions0.5mg elsunersen (Drug), 1mg elsunersen (Drug), sham procedure (Procedure)→0.5mg elsunersen (Drug), 1mg elsunersen (Drug)
2026-05-08
Study Status, Contacts/Locations v4
Study sites2→4
2025-10-01
Study Status, Contacts/Locations v3
Study sites1→2
2025-08-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-06→confirmed 2025-08-13
Study sitesdetails revised at 1 of 1 site
2025-06-13
Study Identification, Study Status v1
Study title-14 characters
Randomized,A Double-blindClinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety
2025-06-05
Original filing
A Multi-Center, Single-Arm Clinical Trial to Investigate the Efficacy and Safety of Elsunersen in Pediatric Participants with Early Onset SCN2A Developmental and Epileptic Encephalopathy
Trial Details
NCT Number NCT07019922
Lead Sponsor Praxis Precision Medicines
Conditions Epileptic Encephalopathy, SCN2A Encephalopathy
Enrollment 40 participants
Start Date 2025-08-13
Primary Completion 2026-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-03