PRAX-222 Trial for Children with Epilepsy
Phase 1/2
60
about 4.5 years
2–18
1 site in TN
What this study is about
This trial is testing PRAX-222 in children aged 2 to 18 years who have early onset SCN2A developmental and epileptic encephalopathy (DEE). The goal is to learn about the effect of PRAX-222 on these children.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take PRAX-222 - Fixed Doses
- 2.Take PRAX-222 - Initial Ascending Doses
- 3.Take PRAX-222 - Initial Dose
- +2 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Number of participants with treatment-emergent adverse events (Preliminary Safety, Dose Escalation)
Secondary: Change from baseline in Caregiver Global Impression-Severity (CgGI-S) score (Confirmatory Phase), Change from baseline in Clinical Global Impression-Severity (CGI-S) score (Confirmatory Phase), Quality of life as assessed by Quality of Life Inventory-Disability (Confirmatory Phase)
Neurology