A Phase 2/3 Multicenter Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Epilepsy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Focal Epilepsy
  • Age: Between 12 Year(s) - 75 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects must agree to provide all requested demographic information (i.e., biological sex at birth, race, ethnicity (ethnicity collected in US only)).
    2. The subject/ caregiver (as required according to local regulations) is/ are willing and able to attend protocol- specific study appointments within the specified visit windows.
    3. Subjects must be able to swallow tablets whole.
    4. Male and Female subjects 12 to 75 years of age at time of consent (subjects 12 to < 18 years will be enrolled if appropriate approvals are in place).
    5. Ability to keep accurate seizure diaries and miss no more than 4 entries (daily seizure diary) out of 28 days
    6. Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit
    7. Focal Seizures (1) Focal aware seizures with clinically observable signs and/or symptoms (2) Focal impaired awareness seizures with clinically observable signs and/or symptoms (3) Focal to bilateral tonic-clonic seizures
    8. Has Drug Resistant Focal Onset Seizures. Meaning failure of adequate trials of two tolerated and appropriately chosen and used ASM schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
    9. An accurate clinical diagnosis of observable focal onset seizures
    10. Historical neuroimaging (e.g. MRI, CT, etc.) with report available. If not previously done or available can be completed during the Screening Phase/OP.
    11. Historical EEG with report available, if not previously done or available can be completed during the Screening Phase/OP.
    12. History of an average of 4 or more observable focal seizures per month (28 days) during the 3 months prior to the screening visit.
    13. Current treatment with at least 1 and up to 3 ASMs as part of no more than 4 stable epilepsy treatments combined (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, 2 ASMs + resection surgery (if completed 1 year prior to the screening visit) + device etc.). Implanted neurostimulation devices, resection surgery (if completed 1 year prior to the screening visit), and epilepsy dietary therapy are considered epilepsy treatments in this trial.
      • ASMs must have a stable dose(s) for at least 1 month prior to the screening visit and ASM(s) present at screening visit must remain stable during participation in the study.
      • Of the subjects = 18 years, only 1 ASM can be a strong CYP3A4 inducer (carbamazepine, phenytoin, phenobarbital, or primidone).
      • Subjects who use felbamate as a concomitant ASM must be taking it for at least 1 year, with a stable dose for 2 months, normal hematology and liver function test (LFT) history prior to screening. If use of felbamate has since been discontinued, it must have been discontinued at least 2 months prior to screening visit.
      • Subjects who use vigabatrin as a concomitant ASM must be taking for at least 2 years and have appropriate documentation of normal visual fields (showing no evidence of vigabatrin-associated clinically significant abnormality).
      • Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS) or other neurostimulation device for epilepsy: (1) That was implanted or activated > 1 year prior to screening visit, and (2) Stimulation parameters have been stable for > 3 months prior to screening visit, and (3) Battery life of unit anticipated to extend for duration of trial.
      • Epilepsy dietary therapy initiated > 3 months prior to screening visit.
      • Medical marijuana and/or derivative are allowed (if local law and regulations permit use) during participation in this study (see eligibility criteria for additional information). For purposes of assessing eligibility for this study, if marijuana and/or derivative are taken for anything other than epilepsy (e.g., pain, sleep aid, or anxiety aid), it is not considered an ASM. If any form of marijuana and/or derivative are taken for seizure treatment, it is considered an ASM in this study. Marijuana and/or derivative use should remain stable and consistent throughout the study.
      • Benzodiazepine derivatives used as a sleep aid are not considered to be an ASM in this trial, although the site investigator should ensure that the subject is not overly sedated, abusing medication, or would otherwise be a poor candidate for the trial.
    14. Any subjects with previous use of ezogabine must have documentation of stable visual acuity and fundoscopic exam.
    15. Ability to complete all study procedures, measurements (including functional assessments) and visits.
    16. Female of childbearing potential (FOCBP) and fertile men with female partners who are FOCBP 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 (i.e., beginning 30 days prior to Day 1/Randomization and extending to 30 days for females and 90 days for males after the last dose of IP). Any hormonal method must be at a stable dose for at least 3 months prior to the screening visit.
    17. FOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to randomization at baseline/day 1.
    18. Compliance with measures to prevent pregnancy and restrictions on sperm and egg donation

You may not be eligible for this study if the following are true:

    1. Prisoners or subjects who are involuntarily incarcerated.
    2. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
    3. Participation in any other investigational clinical trial while participating in this clinical trial (including OP).
    4. Exposure to non-biological investigational agents within 30 days or 5 half-lives (whichever is longer) prior to the Screening visit.
    5. Non-focal seizures
    6. Subject has seizures secondary to drug or alcohol use, ongoing infection, neoplasia demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive CNS disease.
    7. 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 seizures.
    8. History of repetitive/cluster seizures (where individual seizures cannot be counted) either within the last 6 months prior to screening visit or unknown seizure count during OP.
    9. Use of rescue medication more than 2 times within 1 month (28 days) in the last 3 months prior to the screening visit.
    10. Use of rescue medication more than 2 times a month during the OP.
    11. Current or history of psychogenic non-epileptic seizures in the past 2 years.
    12. Transcranial Magnetic Stimulation (TMS) treatment < 3 month prior to the screening visit.
    13. Resection neurosurgery for seizures < 4 months prior to the screening visit.
    14. Radiosurgery performed < 2 years prior to the screening visit.
    15. Diagnosis of clinically significant psychiatric disorder including, but not limited to, any psychotic disorder, schizophrenia, severe bipolar or unipolar moderately-severe may be repeated once.
    16. History of anaphylaxis to, or a clinically important reaction to a potassium channel modulator.
    17. Any malignancy within 5 years prior to screening; if treated with chemotherapy, must be without nervous system complications. Non-melanoma skin malignancies, such as a basal cell or squamous cell carcinoma are allowed if cancer free at baseline visit.
    18. History or presence of gastrointestinal or other disease known to interfere with absorption, distribution, metabolism, or excretion of drugs, or a history of surgery known to interfere with absorption or excretion of drugs (i.e., gastric bypass).
    19. Current diagnosis or history of substance abuse (excluding nicotine or caffeine) or alcohol abuse (DSM-5® criteria) < 2 years prior to the screening visit, as verified with legal representative(s), if applicable, and in the opinion of the Investigator.
    20. Clinically significant hepatic (e.g., viral hepatitis, autoimmune hepatitis; primary biliary cirrhosis; non-alcoholic fatty liver disease; alcoholic liver disease or, any other liver disease), renal, pulmonary, gastrointestinal, neurological, autoimmune, immunological, infectious, hematological, malignant conditions that may interfere with study conduct, as judged by the Investigator.
    21. Any major surgery within 4 weeks of screening visit.
    22. Blood transfusion within 4 weeks of screening visit.
    23. Women who are pregnant or breastfeeding.
    24. Subjects treated with, or likely to require medications or supplements, with significant CYP3A4 interactions (including strong inducers and strong and moderate inhibitors of CYP3A4) such as St. John's wort and rifampin
    25. Subjects = 18 years at time of initial consent treated with = 2 concomitant medications of a strong CYP3A4 inducers (1 ASM that is a strong CYP3A4 inducer is allowed;
    26. Subjects < 18 years at time of initial consent, treated with a strong CYP3A4 inducer ASM (e.g., carbamazepine, phenytoin, phenobarbital, primidone) are not allowed.
    27. History of severe constipation requiring hospitalization or gastrointestinal obstruction.
    28. Detectable levels of cocaine, amphetamine (see below), phencyclidine (PCP), MDMA, cannabinoids (see below), methadone, barbiturates, opiates, methamphetamines in the urine drug screen at the Screening visit are exclusionary. For prescribed barbiturates and opiates, consult with Sponsor. Retesting is not allowed.
      • Subjects who are positive for amphetamines, and who are on a prescribed amphetamine medication for an approved indication (e.g., ADHD) will be allowed into the study at the Investigator’s discretion. This determination by the Investigator must be well documented in the subject’s source medical records. The stimulant dose must be stable from 3 months prior to baseline/randomization and for the duration of the study.
      • Detectable levels of marijuana in the drug screen are not exclusionary (if local law and regulations permit use), if in the Investigator’s documented opinion, the subject does not meet DSM-V criteria for substance use disorder, and the positive test does not signal a clinical condition that would impact the safety of the subject or interpretation of the study results.



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