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 defined
by 2017 International League Against Epilepsy (ILAE) Classification and based on
requirements of Epilepsy Adjudication criteria.

a. Focal seizures i. Focal aware seizures with clinically observable signs and/or
symptoms ii. Focal impaired awareness seizures with clinically observable signs
and/or symptoms iii. Focal to bilateral tonic-clonic seizures

3. Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of
adequate trials of two tolerated and appropriately chosen and used anti-seizure
medication (ASM) schedules (whether as monotherapies or in combination) to achieve
sustained 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 in
total (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.)

Key Exclusion Criteria:

1. History of status epilepticus (convulsive status epilepticus for > 5 minutes or
focal status epilepticus with impaired conscious for > 10 minutes) within the last 6
months prior to screening visit that is not consistent with the subject's habitual
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 or
psychic phenomena only, without impairment of consciousness or awareness (formally
called simple partial seizures), with or without ictal EEG correlation with clinical
symptoms.

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