A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy
60 patients around the world
Available in Brazil, United States
Praxis Precision Medicines
2Research sites
60Patients around the world
This study is for people with
Epilepsies
Epilepsy
Epileptic Encephalopathies
Epileptic Encephalopathies and Developmental Epilepsies (DEE)
Requirements for the patient
To 18 Years
All Gender
Medical requirements
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.
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.
Sites
Praxis Pesquisa Médica s/s LTDA
Recruiting
Alameda Francisco Alves, 169. Sala 193 -194, CEP: 09090-790, Santo André - SP
Hospital de Clínicas de Porto Alegre
Recruiting
Rua Ramiro Barcelos, 2350, Av. Protásio Alves, 211 - Santa Cecília, Porto Alegre - RS, 90035-903
SponsorPraxis Precision Medicines
Study typeInterventional
Conditions
EpilepsyEpileptic Encephalopathies and Developmental Epilepsies (DEE)