Status:
RECRUITING
A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy
Lead Sponsor:
Praxis Precision Medicines
Conditions:
SCN2A-DEE
Epilepsy
Eligibility:
All Genders
2-18 years
Phase:
PHASE1
PHASE2
Brief 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 Criteria
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
Key Trial Info
Start Date :
April 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05737784
Start Date
April 13 2023
End Date
September 1 2027
Last Update
August 21 2025
Active Locations (3)
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1
Le Bonheur Childrens Hospital
Memphis, Tennessee, United States, 38103
2
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
3
Praxis Research Site
São Paulo, Brazil, 05403-010