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A Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies (DEE)

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NCT05818553

Sponsored by Praxis Precision Medicines (industry) · PRAX — their whole pipeline →.

Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
77estimated
Sites
8
Countries
Israel, Spain, United Kingdom +1

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
DateFiledBasisWhat it is
Start2023-08-02actualWhen the study began enrolling
Primary completion2025-11-12actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2027-03-01estimatedThe whole study's end, after follow-up
First posted2023-04-19actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-01-29actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • SCN2A Encephalopathy
  • SCN8A Encephalopathy

Intervention

  • Drug: PRAX-562

Primary outcomes

what the primary-completion date above is the date OF
PART A (Cohorts 1 and 2) RDB: To evaluate the safety and tolerability of PRAX 562 in pediatric participants with SCN2A- and SCN8A- DEEs
measured 16 weeks
PART B (Cohorts 1 and 2) OLE: To evaluate the long-term safety and tolerability of PRAX-562 in pediatric participants with DEEs
measured 48 weeks

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