RISE 2

This research study is being done to see the effectiveness and safety of a new drug called BHV-7000 as a possible treatment for focal seizures for patients who are taking antiseizure medications (ASMs) and still experience seizures. Refractory focal epilepsy is when someone continues to have focal seizures despite treatment with ASMs or other treatments.

Clinical Trials.gov Website:

Record History | ver. 9: 2024-03-14 | NCT06132893 | ClinicalTrials.gov

Sponsor:

Focal Epilepsy | Clinical Trial

Male and Female participants 18 to 75 years of age

-Diagnosis of Focal Onset Epilepsy at least 1 year ago. This diagnosis can include focal aware seizures with clinically observable signs/and or symptoms, focal impaired awareness seizures, focal to bilateral tonic-clonic seizures, as well as drug-resistant focal onset seizures

-Average of 4 or more observable focal seizures per month (28 days) within the past 3 months

-Participants must be on a stable regimen with at least 1 and up to 3 anti-seizure medications, defined as taking the same dose and frequence for at least this past month. (Of note, other epilepsy therapies such as epilepsy surgeries, devices, and diet therapy, together count as 1 treatment) Participants may be on a total of up to 4 treatments.

--only one antiseizure medication can include carbamazepine, phenytoin, phenobarbital or primidone)

Exclusion Criteria

-Participants cannot be pregnant or breastfeeding; if a woman is of childbearing potential, she must use acceptable birth control; a woman who is a partner of a fertile male participant must use acceptable birth control

-Participants of East Asian or Southeast Asian ancestry, defined as participants who have a parent or grandparent who is from an East Asian or Southeast Asian country (e.g. Japan, China, Taiwan, South Korea, Singapore, Hong Kong, Macau, Mongolia, Vietnam, Malaysia, Thailand, and the Philippines).

-Seizures that are secondary to drug or alcohol use, ongoing infection, or progressive CNS disease

-History of status epilepticus within the last 6 months that is not consistent with the participant’s habitual seizures

-History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months

-Use of rescue medication more than 2 times within 1 month, within the last 3 months.