A Phase 2, Double-Blind, Randomized Clinical Trial to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of PRAX-562 in Pediatric Participants with Developmental and Epileptic Encephalopathies Followed by an Open-Label Extension

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502298-41-00

Acronym

PRAX-562-221

Enrollment

Registered

2023-05-17

Start date

2023-08-23

Completion date

Unknown

Last updated

2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SCN2A and SCN8A developmental and epileptic encephalopathy (SCN2A DEE and SCN8A DEE)

Brief summary

Part A (Cohorts 1 and 2) & B: Incidence and severity of treatment-emergent adverse events (TEAEs), Part A (Cohorts 3 and 4): Change from baseline in monthly (28-day) motor seizure frequency

Detailed description

Part A (Cohorts 1 and 2) & B: Change from baseline in monthly (28-day) motor seizure frequency, Part A & B: Plasma concentrations of PRAX-562, Part A (Cohorts 3 and 4): Incidence and severity of treatment-emergent adverse events (TEAEs), Part A (Cohorts 3 and 4): Number of motor seizure-free days -CGI-I at end of treatment -CgGI-I at end of treatment

Interventions

DRUGPRAX-562 placebo powder for oral suspension

DRUGPRAX-562

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Part A (Cohorts 1 and 2) & B: Incidence and severity of treatment-emergent adverse events (TEAEs), Part A (Cohorts 3 and 4): Change from baseline in monthly (28-day) motor seizure frequency	—

Secondary

Measure	Time frame
Part A (Cohorts 1 and 2) & B: Change from baseline in monthly (28-day) motor seizure frequency, Part A & B: Plasma concentrations of PRAX-562, Part A (Cohorts 3 and 4): Incidence and severity of treatment-emergent adverse events (TEAEs), Part A (Cohorts 3 and 4): Number of motor seizure-free days -CGI-I at end of treatment -CgGI-I at end of treatment	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026