RecruitingPhase 3NCT07019922

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

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

Sponsor

Praxis Precision Medicines

Enrollment

40 participants

Start Date

Aug 13, 2025

Study Type

INTERVENTIONAL

Conditions

Epileptic Encephalopathy SCN2A Encephalopathy

Summary

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

Eligibility

Min Age: 1 DayMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 0.5mg elsunersen and a drug called 1mg elsunersen for people with epileptic encephalopathy and scn2a encephalopathy. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 1 Day to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG1mg elsunersen

24 weeks every 4 weeks intrathecally

DRUG0.5mg elsunersen

24 weeks every 4 weeks intrathecally

Locations(10)

Praxis Research Site

San Diego, California, United States

Praxis Research Site

Aurora, Colorado, United States

Praxis Research Site

Chicago, Illinois, United States

Praxis Research Site

Cincinnati, Ohio, United States

Praxis Research Site

Philadelphia, Pennsylvania, United States

Praxis Research Site

Memphis, Tennessee, United States

Praxis Research Site

Porto Alegre, Brazil

Praxis Research Site

São Paulo, Brazil

Praxis Research Site

Bonn, Bonn, Germany

Praxis Research Site

Rome, Italy

View Full Details on ClinicalTrials.gov

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NCT07019922

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