A Clinical Trial of PRAX-222 in Pediatric Participants with Early Onset SCN2A Developmental and Epileptic Encephalopathy

Description

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.

Conditions

SCN2A-DEE, Epilepsy

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Study Overview

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Study Details

Study overview

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.

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

A Clinical Trial of PRAX-222 in Pediatric Participants with Early Onset SCN2A Developmental and Epileptic Encephalopathy

Condition
SCN2A-DEE
Intervention / Treatment

-

Contacts and Locations

Memphis

Le Bonheur Childrens Hospital, Memphis, Tennessee, United States, 38103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

2 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Praxis Precision Medicines,

Medical Director, STUDY_DIRECTOR, Praxis Precision Medicines

Study Record Dates

2027-09