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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07227857 | A First-in-human Study of S230815 in Pediatric Participants With KCNT1-related Developmental and Epileptic Encephalopathy | PHASE1 | RECRUITING | 20 | — | — | Nov 24, 2025 | Apr 15, 2028 | May 12, 2026 | 16 | United States, France +3 |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| Cohort 4 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| S230815- Starting dose A | DRUG | Solution for injection |
| S230815- Dose B | DRUG | Solution for injection |
| S230815- Dose C | DRUG | Solution for injection |
| S230815- Dose D | DRUG | Solution for injection |
Inclusion Criteria: * Male or female pediatric participants aged 2-12 years old at screening, with a genetically confirmed diagnosis of Developmental Epileptic Encephalopathy (DEE) due to a pathogenic or likely pathogenic variant in KCNT1 confirmed by central genetic testing. * Stable dose of other...