A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy

• Status: Recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Praxis Precision Medicines
• Treatments: Pramoxine

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