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A Study of PRAX-222 for Early Onset SCN2A Developmental and Epileptic Encephalopathy

This study is looking at a drug called PRAX-222 for children aged 2 to 18 years old who have early onset SCN2A developmental and epileptic encephalopathy (DEE). This is a severe form of epilepsy that starts very early in life. The study aims to see how safe PRAX-222 is and how well it can reduce seizures. To join, children must have had seizures before 3 months of age and have a confirmed SCN2A gene change. The study plans to enroll 60 participants. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 60 participants and will compare PRAX-222 at different doses with a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety from screening (up to 8 weeks before treatment) through up to 92 weeks. Seizure frequency will be measured between 36 and 40 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05737784

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

Active, Not Recruiting
PHASE1Ages 2–18InterventionalTreatment
Praxis Precision Medicines
~60 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:PRAX-222 - Initial DosePRAX-222 - Initial Ascending DosesPRAX-222 - Optional Ascending DosesPRAX-222 - Fixed DosesPlacebo

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-emergent adverse events (Preliminary Safety, Dose Escalation)
Measured over Screening (-8 weeks) through up to 92 weeks
+1 more outcome measured

Conditions

SCN2A-DEE
Epilepsy

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Developmental and Epileptic EncephalopathySCN2A Gene

NCT05737784

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, Brazilno site contact published

  • Le Bonheur Childrens Hospital

    Memphis, Tennesseeno site contact published

  • Praxis Research Site

    São Paulo, Brazilno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Praxis Precision Medicines

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Number of participants with treatment-emergent adverse events (Preliminary Safety, Dose Escalation)Screening (-8 weeks) through up to 92 weeks

    The number of participants with treatment-emergent adverse events will be reported by severity and preferred term.

  • Seizure frequency (Confirmatory Phase)36 to 40 weeks

    Seizure frequency will be captured by a seizure diary and outcomes will be measured by summing the seizure frequency over a 28-day time period following the 6th dose administration in the confirmatory phase.