Clinical Trials in the USA / NCT05818553
Active, not recruiting
Phase 2/3
A Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies (DEE)
NCT05818553 · tracked via the Priya Life Science USA tracker
Condition(s) studied
SCN2A EncephalopathySCN8A Encephalopathy
Study summary
A Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies (DEE)
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- PART A (Cohorts 1 and 2) RDB: To evaluate the safety and tolerability of PRAX 562 in pediatric participants with SCN2A- and SCN8A- DEEs — 16 weeks
Changes from baseline in monthly (28-day) motor seizure frequency - PART B (Cohorts 1 and 2) OLE: To evaluate the long-term safety and tolerability of PRAX-562 in pediatric participants with DEEs — 48 weeks
Incidence and severity of TEAEs
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Praxis Research Site | Atlanta | Georgia | |
| Praxis Research Site | Chicago | Illinois | |
| Praxis Research Site | Minneapolis | Minnesota | |
| Praxis Research Site | Hackensack | New Jersey | |
| Praxis Research Site | Tel HaShomer | Israel | |
| Praxis Research Site | Madrid | Spain | |
| Praxis Research Site | Glasgow | United Kingdom | |
| Praxis Research Site | London | United Kingdom |
More Praxis Precision Medicines trials in the USA
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Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05818553 on ClinicalTrials.gov ↗ ← All trials in the USA