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A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy
Sponsor: Praxis Precision Medicines
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.
Official title: 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
Key Details
Gender
All
Age Range
2 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-04-13
Completion Date
2027-09
Last Updated
2025-08-21
Healthy Volunteers
No
Interventions
PRAX-222 - Initial Dose
PRAX-222
PRAX-222 - Initial Ascending Doses
Ascending doses of PRAX-222
PRAX-222 - Optional Ascending Doses
Escalation of PRAX-222 dose(s)
PRAX-222 - Fixed Doses
Fixed-dose(s) of PRAX-222 not to exceed the maximum tolerated dose of PRAX-222
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