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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - Additional inclusion criteria apply and will be assessed by the study team Who Should NOT Join This Trial: - 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 - Additional exclusion criteria apply and will be assessed by the study team Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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. * Additional inclusion criteria apply and will be assessed by the study team Exclusion Criteria: * 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 * Additional exclusion criteria apply and will be assessed by the study team

Treatments Being Tested

DRUG

PRAX-222 - Initial Dose

PRAX-222

DRUG

PRAX-222 - Initial Ascending Doses

Ascending doses of PRAX-222

DRUG

PRAX-222 - Optional Ascending Doses

Escalation of PRAX-222 dose(s)

DRUG

PRAX-222 - Fixed Doses

Fixed-dose(s) of PRAX-222 not to exceed the maximum tolerated dose of PRAX-222

PROCEDURE

Placebo

Placebo procedure

Locations (3)

Le Bonheur Childrens Hospital
Memphis, Tennessee, United States
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Praxis Research Site
São Paulo, Brazil