A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy
← catalyst calendarSponsored by Praxis Precision Medicines (industry) · PRAX — their whole pipeline →.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
60estimated
Sites
3
Countries
Brazil, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-04-13 | actual | When the study began enrolling |
| Primary completion | 2026-04-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2023-02-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- SCN2A-DEE
- Epilepsy
Interventions
- Drug: PRAX-222 - Initial Dose
- Drug: PRAX-222 - Initial Ascending Doses
- Drug: PRAX-222 - Optional Ascending Doses
- Drug: PRAX-222 - Fixed Doses
- Procedure: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with treatment-emergent adverse events (Preliminary Safety, Dose Escalation)
measured Screening (-8 weeks) through up to 92 weeks
Seizure frequency (Confirmatory Phase)
measured 36 to 40 weeks
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