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RECRUITING
NCT05737784
PHASE1/PHASE2

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

Sponsor: Praxis Precision Medicines

View on ClinicalTrials.gov

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

DRUG

PRAX-222 - Initial Dose

PRAX-222

DRUG

PRAX-222 - Initial Ascending Doses

Ascending doses of PRAX-222

DRUG

PRAX-222 - Optional Ascending Doses

Escalation of PRAX-222 dose(s)

DRUG

PRAX-222 - Fixed Doses

Fixed-dose(s) of PRAX-222 not to exceed the maximum tolerated dose of PRAX-222

PROCEDURE

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