Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RAP-219 · 5 trials · 8 indications
Median percent change in seizure frequency and ≥ 50% seizure frequency reduction responder rates:
The YMRS is a clinician administered scale that consists of 11 items used to assess the severity of manic symptoms (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.
Change in long episode frequency per 28-day period during the treatment period compared to baseline
| Arm | Type | Description |
|---|---|---|
| Active Arm- High Dose | EXPERIMENTAL | RAP-219 daily tablets administered orally |
| Active Arm- Medium Dose | EXPERIMENTAL | RAP-219 daily tablets administered orally |
| Placebo | PLACEBO_COMPARATOR | Inert comparator matching the active treatment |
| Active Arm-Low Dose | EXPERIMENTAL | RAP-219 daily tablets administered orally |
| RAP-219 | EXPERIMENTAL | - |
| Active Arm | EXPERIMENTAL | Treatment with RAP-219 |
| Name | Type | Description |
|---|---|---|
| RAP-219 | DRUG | RAP-219 high dose tablets administered orally daily |
| Placebo | OTHER | Matching placebo tablets administered orally daily |
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...