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

ACTIVE_NOT_RECRUITINGPHASE2/PHASE3

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

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 Open-Label Extension(OLE)

NCT05818553•Praxis Precision Medicines

View on ClinicalTrials.gov

Summary

Detailed Description

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.

Eligibility

Age

1 - 18 years

Sex

ALL

Healthy Volunteers

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).

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.

Locations (8)

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

Key Dates

Start Date

August 2, 2023

Primary Completion Date

November 12, 2025

Completion Date

March 1, 2027

Last Updated

January 29, 2026

Enrollment

ESTIMATED participants

Conditions

SCN2A EncephalopathySCN8A Encephalopathy

Interventions

PRAX-562

DRUG