U.S., June 14 -- ClinicalTrials.gov registry received information related to the study (NCT07019922) titled 'Randomized, Double-blind Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety' on June 05.
Brief 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
Study Start Date: June, 2025
Study Type: INTERVENTIONAL
Condition:
Epileptic Encephalopathy
SCN2A Encephalopathy
Intervention:
DRUG: 1mg elsunersen
24 weeks every 4 weeks intrathecally
PROCEDURE: sham procedure
24 weeks of sham-procedure every 4 weeks
DRUG: 0.5mg elsunersen
...