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

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: SCN2A Encephalopathy, SCN8A Encephalopathy

In brief

Key facts

Study ID: NCT05818553
Run by: Praxis Precision Medicines
People needed: 77
Starts: 2023-08-02
Expected to finish: 2027-03-01
Last updated by the study team: 2026-01-29

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Has a documented variant in SCN2A with onset of seizures occurring in the first 3 months of life or has a diagnosis of SCN8A-DEE supported by both clinical and genetic findings.
Has a seizure frequency as follows:
At least 8 countable motor seizures in the 4 weeks immediately prior to Screening as reported by the parent/legal guardian or in the opinion of the investigator as documented in medical notes.
AND o At least 8 countable motor seizures during the 28 day Baseline Observation Period (during which seizure frequency is recorded in a daily seizure diary).
Additional inclusion criteria apply and will be assessed by the study team.

You may not qualify if…

Has any clinically significant or known pathogenic or likely pathogenic genetic variant other than in SCN2A and SCN8A or a genetic variant that may explain or contribute to the participant's epilepsy and/or developmental disorder.
Has a documented, functionally characterized loss-of-function (LoF) missense variant or a presumed LoF variant (nonsense or frameshift variant) based on genetic testing and/or clinical evidence that prior exposure to a sodium channel blocker (SCB) medication worsened seizures.
Has 2 or more episodes of convulsive status epilepticus requiring hospitalization and intubation in the 6 months prior to Screening.
Additional exclusion criteria apply and will be assessed by the study team.

Where it is running

Praxis Research Site — Atlanta, Georgia, United States
Praxis Research Site — Chicago, Illinois, United States
Praxis Research Site — Minneapolis, Minnesota, United States
Praxis Research Site — Hackensack, New Jersey, United States
Praxis Research Site — Tel Litwinsky, Israel
Praxis Research Site — Madrid, Spain
Praxis Research Site — Glasgow, United Kingdom
Praxis Research Site — London, United Kingdom

Full record on ClinicalTrials.gov

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