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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07594119 | Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures | PHASE3 | RECRUITING | 312 | — | — | Jun 1, 2026 | Sep 1, 2029 | Jun 8, 2026 | 2 | United States |
| NCT07563881 | Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1 | PHASE3 | RECRUITING | 333 | — | — | May 1, 2026 | Sep 1, 2029 | May 29, 2026 | 2 | United States |
Median percent change in seizure frequency and ≥ 50% seizure frequency reduction responder rates
| Arm | Type | Description |
|---|---|---|
| Active Arm- Medium Dose | EXPERIMENTAL | RAP-219 daily tablets administered orally |
| Active Arm-Low Dose | EXPERIMENTAL | RAP-219 daily tablets administered orally |
| Placebo | PLACEBO_COMPARATOR | Inert comparator matching the active treatment |
| Active Arm- High Dose | EXPERIMENTAL | RAP-219 daily tablets administered orally |
| Name | Type | Description |
|---|---|---|
| RAP-219 | DRUG | RAP-219 medium dose tablets administered orally daily |
| Placebo | OTHER | Matching placebo tablets administered orally |
Inclusion Criteria: 1. Age 18 - 75 2. BMI 18-45 kg/m2 3. Diagnosis of focal epilepsy for ≥24 months prior to Visit 1 4. Report from at least 1 brain MRI or CT scan and 1 EEG study, each completed within 10 years prior to Visit 1, consistent with focal epilepsy diagnosis 5. Concomitant use of betwee...