BHV-7000 Responsive Neurostimulation System (RNS) Study

Launched by YALE UNIVERSITY · Aug 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BHV-7000, which is being tested to help people with focal epilepsy—a type of epilepsy where seizures start in one area of the brain. Participants in the study already have a device called the Responsive Neurostimulation (RNS) System implanted in their brain, which monitors and records seizure activity. The goal is to see how BHV-7000 affects abnormal brain activity detected by this device. The medication will be taken for 4 weeks, and researchers will compare brain activity during this time to activity recorded before and after taking the drug.

People who might be eligible for this study are adults with focal epilepsy who have had the RNS device implanted for at least a year and whose device shows ongoing seizure-related brain activity. Participants must be able to take oral medication and agree to follow the study rules, including certain birth control measures if applicable. During the study, participants will take BHV-7000 for a month and have their brain activity closely monitored through the RNS device. This trial is not yet recruiting, and it’s designed to better understand how this new medication might help control seizures by targeting brain activity directly recorded by the device.

Gender

ALL

Eligibility criteria

• 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.
• • Provision of signed and dated informed consent form.
• • Ability to take oral medication and be willing to adhere to the BHV-7000 treatment regimen.
• • WOCBP may be included if they agree to use 2 methods of contraception, at least one of which is considered to be highly effective for the duration of the study (i.e., beginning 30 days prior to dosing and extending until at least 60 days post-last dose of BHV-7000.
• • WOCBP must agree not to donate ova from the time of the first administration of study drug until at least 60 days post-last dose of BHV-7000.
• • Fertile males may be included, but if they have a partner who is a woman of childbearing potential (WOCBP), they must agree to use 2 methods of contraception, at least one of which is considered to be highly effective for the duration of the study and extending to 120 days after the last dose of study drug. Non fertile men or men with partners who are women of non-childbearing potential (WONCBP) are not required to use contraception.
• • Fertile males must agree not to donate sperm from the time of the first administration of study drug until 120 days after the last dose of study drug.
• • Body mass index (BMI) \< 40 kg/m² at screening visit.
• Exclusion Criteria:
• • Change in any antiseizure medication (including addition or discontinuation of any antiseizure
• • Any change in RNS detection settings within 90 days prior to planned treatment Day 1.
• • Change in RNS stimulation settings within 90 days prior to planned drug administration (retrospective baseline period).
• • Poor or inconsistent history of device downloads in the 90 days prior to planned treatment Day 1, as determined by less than 90% of episode start data being available at treatment Day 1.
• • RNS battery low (estimated to last for less than 3 months).
• • History or presence of any significant medical or surgical condition or uncontrolled medical illness at screening including, but not limited to, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, endocrine, hepatic or urogenital systems, or other conditions that would place the participant at increased risk as determined by the PI.
• * Any clinically significant laboratory abnormalities or clinically significant abnormalities on screening physical examination, vital signs, or ECG that, in the judgment of the PI, indicates a medical problem that would preclude study participation. Any significant laboratory, vital sign and examination abnormality should be discussed with the Sponsor medical monitor before including the participant. Some specific laboratory abnormalities that would fall in this category include:
• • a. Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2 b. Hematologic abnormalities at screening: i. Hemoglobin ≤ 10 g/dL; or ii. WBC \< 3.0 x 10³/mm³; or iii. Platelet count \< 100,000 cell/mm³; or iv. Neutrophils, Absolute ≤ 1000 cell/mm³ c. Hemoglobin A1C \> 7.0% d. Screening ALT, AST \> 2, or total bilirubin \> 1.5 x upper limit of reference range (one re-test is allowed prior to baseline/randomization): e. Participants with chronically, stable (for \> 6 months) elevated liver enzymes that are ≤ 3 x ULN that is related to ASM treatment may be eligible determined by discussion with Medical Monitor.
• • f. Participants with diagnosis of Gilbert's syndrome may be included with Medical Monitor approval.
• • g. A positive test for HBsAg, HCV Ab, or HIV- 1/2 Ag/Ab at screening. h. A positive pregnancy test.
• • Schizophrenia and other psychotic disorders (e.g., schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified \[NOS\]), bipolar disorder, and/or obsessive-compulsive disorder, or other serious mental health disorders. Uncontrolled unipolar major depression where changes in pharmacotherapy are needed or anticipated during the study.
• • Active suicidal plan/intent in the past six months, a suicide attempt in the last two years, or more than one lifetime suicide attempt.
• • Females who are pregnant, breastfeeding, or planning to become pregnant from screening until 60 days post-last dose of BHV-7000.
• • History of illicit drug or alcohol abuse within one year prior to screening judged by the PI to be excessive or compulsive, or currently using drugs of abuse or any prescribed or over the counter medication in a manner that the PI considers indicative of abuse or dependence.
• • Participants taking strong or moderate CYP3A4 inhibitors or strong inducers. If the participant is on a strong or moderate inhibitor or strong inducer of CYP3A4, an alternate drug must be sought.
• • Exposure to any other investigational drug or device within five half-lives or 30 days prior to screening, whichever is longer.
• • History of cancer within the past two years, with the exception of appropriately treated basal cell or squamous cell carcinoma.
• • History of recurrent severe constipation, fecal impaction, or gastrointestinal obstruction requiring hospitalization.
• • History of clinically significant urinary retention in the judgment of the PI.
• • Previous exposure to BHV-7000 or known allergy to BHV-7000 or its excipients.
• • Any major surgery within one month or an acute illness within two weeks prior to screening.
• • Vaccination within the previous four weeks prior to screening or planned vaccination during the study.
• • History of ezogabine use.
• • Known allergic reactions to components of the study drug.
• • Febrile illness within 90 days prior to planned treatment Day 1.
• • Presence of any retinal abnormality on baseline ophthalmic examination.
• • Significant cardiovascular history, including but not limited to uncontrolled angina, myocardial infarction (Ml) within 12 months of screening, clinically significant arrhythmia, congestive heart failure (New York Heart Association \[NYHA\] Class Ill or higher).
• • QTcF (Fridericia) interval 450 msec for males and 470 msec for females; Mobitz Type II second or third degree atrioventricular (AV) block, or complete left bundle branch block, or complete right bundle branch block, or intraventricular conduction defect with a QRS duration 130 msec, or evidence of acute or sub-acute myocardial infarction (Ml) or ischemia, or other ECG findings that, in the investigator's opinion, would preclude participation in the study.