A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy
A Seamless, Clinical Trial to Investigate the Safety and Efficacy of Multiple Doses of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy
Praxis Precision Medicines
60 participants
Apr 13, 2023
INTERVENTIONAL
Conditions
Summary
The goal of this trial is to learn about the effect of PRAX-222 in pediatric participants with early onset SCN2A developmental and epileptic encephalopathy (DEE), aged 2 to 18 years.
Eligibility
Inclusion Criteria3
- Has onset of seizures prior to 3 months of age.
- Has a minimum weight of at least 10 kg at screening.
- Has a documented SCN2A variant through genetic testing obtained via a laboratory accredited per Clinical Laboratory Improvement Amendments (CLIA) or College of American Pathologists (CAP) or equivalent.
Exclusion Criteria2
- Has any clinically significant or known pathogenic genetic variant other than in the SCN2A gene, or a genetic variant that may explain or contribute to the participant's epilepsy and/or developmental disorder.
- Is taking more than 2 sodium channel blocking anti-seizure medications
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Interventions
PRAX-222
Ascending doses of PRAX-222
Escalation of PRAX-222 dose(s)
Fixed-dose(s) of PRAX-222 not to exceed the maximum tolerated dose of PRAX-222
Placebo procedure
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05737784