Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

Key Inclusion Criteria:

1. Male and Female participants 18 to 75 years of age at time of consent.

2. Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit definedby 2017 International League Against Epilepsy (ILAE) Classification and based onrequirements of Epilepsy Adjudication criteria. a. Focal seizures i. Focal aware seizures with clinically observable signs and/orsymptoms ii. Focal impaired awareness seizures with clinically observable signsand/or symptoms iii. Focal to bilateral tonic-clonic seizures

3. Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure ofadequate trials of two tolerated and appropriately chosen and used anti-seizuremedication (ASM) schedules (whether as monotherapies or in combination) to achievesustained seizure freedom.

4. Ability to keep accurate seizure diaries

5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments intotal

Key Exclusion Criteria:

1. History of status epilepticus (convulsive status epilepticus for > 5 minutes orfocal status epilepticus with impaired consciousness for > 10 minutes) within thelast 6 months prior to screening visit that is not consistent with the subject'shabitual seizure.

2. History of repetitive/cluster seizures (where individual seizures cannot be counted)within the last 6 months prior to screening visit and during observation phase.

3. Resection neurosurgery for seizures <4 months prior to the screening visit.

4. Radiosurgery performed <2 years prior to the screening visit.

5. Subjects with only focal aware nonmotor seizures which involve subjective sensory orpsychic phenomena only, without impairment of consciousness or awareness (formallycalled simple partial seizures), with or without ictal EEG correlation with clinicalsymptoms.

6. Any condition that would interfere with the subject's ability to comply with studyinstructions, place the subject at unacceptable risk, and/or confound theinterpretation of safety or efficacy data from the study, as judged by theInvestigator