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NCT05737784
A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy
Conditions: SCN2A-DEE, Epilepsy
Sex: All
Ages: 2 Years – 18 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 60
Sponsor: Praxis Precision Medicines
Location: Le Bonheur Childrens Hospital Memphis Tennessee
Summary
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.
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
Source: ClinicalTrials.gov (NCT05737784). StuddyBuddy aggregates publicly available trial information.