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

NCT05737784 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-21

No results posted yet for this 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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Praxis Precision Medicines

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-13
Primary Completion
2025-08-31
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • Brazil

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05737784 on ClinicalTrials.gov