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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06443463 | Long-term Safety and Tolerability of BHV-7000 | PHASE2 | ENROLLING BY_INVITATION | 660 | — | — | Jul 30, 2024 | Jan 1, 2027 | May 1, 2026 | 283 | United States, Argentina +25 |
| NCT06309966 | Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy | PHASE2 | RECRUITING | 390 | — | — | May 13, 2024 | May 1, 2026 | Apr 17, 2026 | 174 | United States, Australia +14 |
| NCT06132893 | A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy | PHASE2 | RECRUITING | 390 | — | — | Mar 14, 2024 | Dec 1, 2026 | May 1, 2026 | 124 | United States, Argentina +12 |
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.
To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 8-week double-blind treatment phase.
To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 12-week double-blind treatment phase.
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.
| Arm | Type | Description |
|---|---|---|
| BHV-7000 50 mg | EXPERIMENTAL | - |
| BHV-7000 75 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| BHV-7000 25 mg Part A | EXPERIMENTAL | - |
| BHV-7000 50 mg Part A | EXPERIMENTAL | - |
| Placebo Part A | PLACEBO_COMPARATOR | - |
| BHV-7000 75 mg Part B | EXPERIMENTAL | - |
| Placebo Part B | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BHV-7000 | DRUG | BHV-7000 50 mg. Participants will take open-label investigational product (IP) once daily |
| Placebo | DRUG | Matching placebo taken once daily |
Key Inclusion Criteria: * Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-303. * (FOCBP) Females of Child Bearing Potential must have a negative urine pregnancy test at the Baseline/Day 0 visit Key Exclusion Criteria: * Any condition, such as an o...