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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07125261 | BHV-7000 Responsive Neurostimulation System (RNS) Study | PHASE1 | ACTIVE NOT_RECRUITING | 5 | — | — | Oct 7, 2025 | Sep 1, 2026 | Mar 9, 2026 | 1 | United States |
Per-participant percentage reduction in patient-specific seizure surrogate rate in the treatment period relative to retrospective baseline.
Per-participant percentage reduction in seizure onset pattern rate in the treatment period relative to retrospective baseline.
Per-participant reduction in long episode rate during the treatment period relative to the retrospective baseline.
Per-participant reduction in saturation rate during the treatment period relative to the retrospective baseline, for those patients who have saturations.
| Arm | Type | Description |
|---|---|---|
| BHV-7000 | EXPERIMENTAL | Participants will receive up to 28 days of study drug and will be followed clinically until Day 56, making their total involvement in the study up to 84 days. The study follows an ABA treatment paradigm with (A) 90-day retrospective RNS baseline, (B) 4-week treatment period, and (A) 4-week withdrawal period. |
| Name | Type | Description |
|---|---|---|
| BHV-700 | DRUG | 75 mg daily for the 4-week treatment period (dose which may be adjusted based on tolerability) |
Inclusion Criteria: * Diagnosis of focal epilepsy as documented in the medical record. * Implanted at least 1 year ago with RNS. * RNS device actively recording intracranial EEG data. * Baseline RNS recordings show that the over 50% of detections represent epileptiform seizure onset patterns. * Pro...