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RECRUITING
NCT07019922
PHASE3

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

Sponsor: Praxis Precision Medicines

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

1 Day - 18 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-08-13

Completion Date

2028-12

Last Updated

2026-05-27

Healthy Volunteers

No

Interventions

DRUG

1mg elsunersen

24 weeks every 4 weeks intrathecally

DRUG

0.5mg 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