2026-01-27
notable
Recruiting→Active, Not Recruiting Study Status, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2026-03-23→confirmed 2025-11-12
Enrollment target100→77
Study sites5→8
Eligibility criteria-53 characters
Inclusion Criteria:
Has a documented rare missense variant in SCN2A with onset of seizures occurring in the first three3 months of life or has a documented de novo (not observed in either parent) missense variant in SCN8A with onsetdiagnosis of seizuresSCN8A-DEE occurringsupported inby theboth firstclinical sixand monthsgenetic of lifefindings.
Has a seizure frequency as follows:
At least 8 countable m [...] parent/legal guardian or in the opinion of the investigator ANDas documented in medical notes.
AND o At least 8 countable motor seizures during the 28 day Baseli [...] ch seizure frequency is recorded i [...]
Secondary endpoints4 to 5 entries
PART A (Cohorts 1 and 2) RDB: To evaluateassess the long-term safety and tolerabilityeffect of PRAX-562 on the frequency of countable motor seizures in pediatric participants with DEEs
To assess the effect of PRAX-562 on the frequency of countable motor seizures in pediatric participants with DEEs
Primary endpoints1 to 2 entries
PART A (Cohorts 1 and 2) RDB: To assessevaluate the effectsafety and tolerability of PRAX 562 in pediatric participants with SCN2A- and SCN8A- DEEs
PART B (Cohorts 1 and 2) OLE: To evaluate the long-term safety and tolerability of PRAX-562 on the frequency of countable motor seizures in pediatric participants with DEEs
Study description+157 characters
A Phase 2, double-blind, randomized clinical trial to evaluate the safety and tolerability of PRAX 562 in pediatric participants with SCN2A- and SCN8A- DEEs.
2025-01-24
minor
Study Status, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v4
PhasePhase 2→Phase 2/3
Primary completion date2024-06-30→2026-03-23
Completion date2025-06-30→2027-03-01
Enrollment target20→100
Study arms2→4
InterventionsPart A: 0.5mg/kg/day PRAX-562 for 12 Weeks and Matching Placebo for 4 Weeks (Drug), Part A: 0.5mg/kg/day PRAX-562 for 16 Weeks (Drug), Part…→PRAX-562 (Drug)
Secondary endpoints3 to 4 entries
To assessevaluate the effectlong-term safety and tolerability of PRAX-562 on the frequency of countable motor seizures in pediatric participants with DEEs
Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability])
Primary endpoints2 to 1 entries
Incidence of Treatment-Emergent Adverse Events (TAEs) [Safety and Tolerability])
To evaluateassess the long-term safety and tolerabilityeffect of PRAX-562 on the frequency of countable motor seizures in pediatric participants with DEEs
Study sitesdetails revised at 3 of 5 sites
2024-01-08
minor
Study Status, Eligibility, Contacts/Locations v3
Primary completion date2025-02-03→2024-06-30
Completion date2025-06-01→2025-06-30
Start date2023-04-11→2023-08-02
Study sites1→5
Eligibility criteria-62 characters
[...] re frequency as follows:
At least 8 countable motor seizures (as defined in the note below) in the 4 weeks immediately prior to Screening as reported b [...] of the investigator AND
At least 8 countable motor seizures (as defined in the note below) during the 28 day Baseline Observation Period (during which [...]
2023-10-17
minor
Study Status v2
Primary completion date2023-09-15→2025-02-03
Completion date2024-03-15→2025-06-01
Start dateestimated 2023-04-17→confirmed 2023-04-11
2023-04-18
minor
Study Identification, Study Status, Arms and Interventions, Outcome Measures, Eligibility v1
Eligibility criteria+24 characters
[...] tic testing and/or clinical evidence that prior exposure to ana sodium channel blocker (SCB) medication worsened seizures.
Has 2 or more episodes of con [...]
Secondary endpoints3 entries, revised
To assess the effect of PRAX-562 on the frequency of countable motor seizures in pediatric participants with DEEs
Plasma concentrations of PRAX-562
Primary endpoints2 entries, revised
Incidence of Treatment-Emergent Adverse Events (TAEs) [Safety and Tolerability])
To evaluate the long-term safety and tolerability of PRAX-562 in pediatric participants with DEEs
Study title+6 characters
A Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies (DEE)
2023-04-17
minor
Original filing