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

Last updated: August 15, 2025
Sponsor: Praxis Precision Medicines
Overall Status: Active - Recruiting

Phase

1/2

Condition

Epilepsy

Neurologic Disorders

Treatment

PRAX-222 - Initial Ascending Doses

Placebo

PRAX-222 - Initial Dose

Clinical Study ID

NCT05737784
PRAX-222-111
  • Ages 2-18
  • All Genders

Study 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

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 laboratoryaccredited per Clinical Laboratory Improvement Amendments (CLIA) or College ofAmerican Pathologists (CAP) or equivalent.

  • Additional inclusion criteria apply and will be assessed by the study team

Exclusion

Exclusion Criteria:

  • Has any clinically significant or known pathogenic genetic variant other than in theSCN2A gene, or a genetic variant that may explain or contribute to the participant'sepilepsy 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

Study Design

Total Participants: 60
Treatment Group(s): 5
Primary Treatment: PRAX-222 - Initial Ascending Doses
Phase: 1/2
Study Start date:
April 13, 2023
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90035-003
    Brazil

    Active - Recruiting

  • Praxis Research Site

    São Paulo, 05403-010
    Brazil

    Active - Recruiting

  • Le Bonheur Childrens Hospital

    Memphis, Tennessee 38103
    United States

    Completed

  • Praxis Research Site

    Memphis, Tennessee 38103
    United States

    Site Not Available

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