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

Running, not enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: SCN2A-DEE, Epilepsy

In brief

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.

Key facts

Study ID

NCT05737784

Run by

Praxis Precision Medicines

People needed

60

Starts

2023-04-13

Expected to finish

2028-02-01

Last updated by the study team

2026-08-03

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Le Bonheur Childrens Hospital — Memphis, Tennessee, United States
• Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
• Praxis Research Site — São Paulo, Brazil

Full record on ClinicalTrials.gov

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