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Recruiting 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
Phase: PHASE1, PHASE2
Enrollment: 60
Sponsor: Praxis Precision Medicines

Location: United States

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 teamExclusion 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 medicationsAdditional exclusion criteria apply and will be assessed by the study team

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05737784). StuddyBuddy aggregates publicly available trial information.