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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 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

Official title: 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

Key Details

Gender

All

Age Range

1 Day - 18 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-08-13

Completion Date

2028-12

Last Updated

2025-10-02

Healthy Volunteers

No

Interventions

DRUG

1mg elsunersen

24 weeks every 4 weeks intrathecally

PROCEDURE

sham procedure

24 weeks of sham-procedure every 4 weeks

DRUG

0.5mg elsunersen

24 weeks every 4 weeks intrathecally

Locations (2)

Praxis Research Site

San Diego, California, United States

Praxis Research Site

Chicago, Illinois, United States