Trials / Recruiting
RecruitingNCT05737784
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Praxis Precision Medicines · Industry
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-04-13
- Primary completion
- 2025-08-01
- Completion
- 2027-09-01
- First posted
- 2023-02-21
- Last updated
- 2025-08-21
Locations
3 sites across 2 countries: United States, Brazil
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05737784. Inclusion in this directory is not an endorsement.