Active, Not Recruiting
Phase 1
Phase 2
Age: 2Years - 18Years
All Genders
ID05737784
A Seamless, Clinical Trial to Investigate the Safety and Efficacy of Multiple Doses of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy
Led by Praxis Precision Medicines · Updated on 2026-08-03
60
Participants Needed
3
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this trial is to learn about the effect of PRAX-222 in pediatric participants with early onset SCN2A developmental and epileptic encephalopathy (DEE), aged 2 to 18 years.
CONDITIONS
Brief Title
A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy
Who Can Participate
Age: 2Years - 18Years
All Genders
Eligibility Criteria
Inclusion Criteria:
- Has onset of seizures prior to 3 months of age.
- Has a minimum weight of at least 10 kg at screening.
- Has a documented SCN2A variant through genetic testing obtained via a laboratory accredited per Clinical Laboratory Improvement Amendments (CLIA) or College of American Pathologists (CAP) or equivalent.
- Additional inclusion criteria apply and will be assessed by the study team
Exclusion Criteria:
- Has any clinically significant or known pathogenic genetic variant other than in the SCN2A gene, or a genetic variant that may explain or contribute to the participant's epilepsy and/or developmental disorder.
- Is taking more than 2 sodium channel blocking anti-seizure medications
- Additional exclusion criteria apply and will be assessed by the study team
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