Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05818553 | A Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies (DEE) | PHASE2 | ACTIVE NOT_RECRUITING | 77 | — | — | Aug 2, 2023 | Mar 1, 2027 | Jan 29, 2026 | 8 | United States, Israel +2 |
Changes from baseline in monthly (28-day) motor seizure frequency
Incidence and severity of TEAEs
| Arm | Type | Description |
|---|---|---|
| Part A: Randomized, Double-Blind 0.5mg/kg/day PRAX-562 or PRAX-562/Placebo | EXPERIMENTAL | Eligible participants from each cohort will be randomized in a 1:1 ratio to either 0.5 milligrams/kilograms/day (mg/kg/day) PRAX-562 for 16 weeks (PRAX-562 arm) or 0.5 mg/kg/day PRAX-562 for 12 weeks and matching placebo for 4 weeks (PRAX-562/placebo arm) administered orally or via gastrostomy tube (G-tube). |
| Part B: Open-Label Extension Treatment 0.5mg/kg/day PRAX-562 | EXPERIMENTAL | Eligible participants will receive 0.5mg/kg/day administered orally or via G-tube for up to 144 weeks. |
| Part A: Randomized, Double-Blind 1.0 mg/kg/day PRAX-562 or PRAX-562/Placebo | EXPERIMENTAL | Eligible participants from each cohort will be randomized in a 1:1 ratio to either 1.0 milligrams/kilograms/day (mg/kg/day) PRAX-562 for 16 weeks (PRAX-562 arm) or 1.0 mg/kg/day PRAX-562 for 12 weeks and matching placebo for 4 weeks (PRAX-562/placebo arm) administered orally or via gastrostomy tube (G-tube). |
| Open-Label Extension Treatment 1.0 mg/kg/day PRAX-562 | EXPERIMENTAL | Eligible participants will receive 1.0 mg/kg/day administered orally or via G-tube for up to 144 weeks. |
| Name | Type | Description |
|---|---|---|
| PRAX-562 | DRUG | Once daily oral or G-tube treatment. |
Inclusion Criteria: * Has a documented variant in SCN2A with onset of seizures occurring in the first 3 months of life or has a diagnosis of SCN8A-DEE supported by both clinical and genetic findings. * Has a seizure frequency as follows: * At least 8 countable motor seizures in the 4 weeks immed...