Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS

Exclusion Criteria

• •1. Female subjects who are pregnant (or planning to become pregnant during the study), lactating or breast-feeding
• •2. History of non-epileptic or psychogenic seizures
• •3. Presence of only non-motor simple partial seizures or primary generalized epilepsies
• •4. History of seizure clusters (episodes lasting less than 30 minutes in which multiple seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished) within 6 months prior to Visit 1
• •5. Presence or previous history of Lennox-Gastaut syndrome
• •6. Scheduled epilepsy surgery within 8 months of Visit 1
• •7. Evidence of any clinically significant laboratory abnormalities or disease (e.g., psychiatric, behavioral problems, cardiac, respiratory, gastrointestinal, hepatic \[liver transaminases, ALT or AST, more than twice the upper limit of normal (ULN) or total or direct bilirubin not within normal limits\], or renal disease) that, in the opinion of the Investigator, could affect subject's safety or conduct of the study.
• •8. Any clinically significant active central nervous system (CNS) infection, demyelinating disease, degenerative neurologic disease, or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results
• •9. Presence of psychotic disorders and/or unstable recurrent affective disorders evident by use of antipsychotics; presence or recent history (within 6 months) of major depressive episode
• •10. Use of intermittent rescue benzodiazepines more than once per month (1 to 2 doses in a 24-hour period is considered as 1 rescue) in the 1-month period prior to Visit 1
• •11. Current or recent use (within 30 days prior to Visit 1) of any of the following medications: diazepam/phenytoin/phenobarbital (or metabolites of these drugs), clopidogrel, fluvoxamine, amitriptyline, clomipramine, bupropion, methadone, ifosfamide, cyclophosphamide, efavirenz, natural progesterone, or traditional Chinese/herbal medicines indicated for neurological system
• •12. Current or recent (within 5 months prior to Visit 1) use of vigabatrin or ezogabine. Subjects with a prior history of treatment with vigabatrin must have documentation showing no evidence of a vigabatrin associated clinically significant abnormality in a visual perimetry test. Subjects with a prior history of treatment with ezogabine should have no evidence of retinal abnormalities with funduscopic features similar to those seen in retinal pigment dystrophies.
• •13. Previous exposure to cenobamate
• •14. Participation in any other trials involving an investigational product or device within 30 days prior to Visit 1
• •15. History of alcoholism, drug abuse, or drug addiction within the past 2 years prior to Visit 1 as assessed by the Investigator
• •16. History of status epilepticus within 3 months of Visit 1
• •17. History of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms \[DRESS\]) or any drug-related rash requiring hospitalization
• •18. History of AED-associated rash that involved conjunctiva or mucosae
• •19. History of any drug-related hypersensitivity reaction that required discontinuation of the medication
• •20. Presence of Familial short QT syndrome or relevant replicated QTc interval (QTcF less than 340 msec or greater than 450 msec in males and greater than 470 msec in females) on electrocardiogram (ECG)
• •21. Absolute neutrophil count less than 1,500/μL
• •22. Platelet counts lower than 80,000/μL in subjects treated with VPA
• •23. Creatinine clearance less than 60 mL/min, as calculated by Cockcroft-Gault equation
• •24. History of positive test results for HBsAg, HCV-Ab, and HIV-Ab
• •25. More than 1 lifetime suicide attempt
• •26. A "YES" answer to Question 1 or 2 of the C-SSRS (Baseline/Screening version) Suicidal Ideation section in the past 6 months or a "YES" answer to any of the Suicidal Behavior Questions in the past 2 years
• •27. Subject is a staff member or immediate family member of study staff.