NCT05737784Active, not recruitingPhase 1/2
A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy
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
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 10 Feb 2023
- Start date
- 13 Apr 2023
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Praxis Precision Medicines
- Diseases
- Epilepsy
- NCT number
- NCT05737784
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 60
- From 13 Apr 2023 to the primary completion date, 1 Apr 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Is taking more than 2 sodium channel blocking anti-seizure medications
Other
- Additional exclusion criteria apply and will be assessed by the study team
Who the study is looking for
- 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
Age in the registry: 2 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Praxis Research Site Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Le Bonheur Childrens Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.