To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset Seizures

Exclusion Criteria

• •1. Hypersensitivity to any component of Fycompa
• •2. Subjects with other sleep problems (except for sleep onset or mixed sleep onset and sleep maintenance insomnia) based on history, standard sleep questionnaires, and PSG at Screening.
• •3. Subjects with a diagnosis of a sleep-related breathing disorder, apnea-hypopnea index of more than 15, periodic limb movement disorder of more than 15, restless legs syndrome, nightmare disorder, sleep terror disorder, sleepwalking disorder, REM behavior disorder, narcolepsy, or circadian rhythm sleep disorder.
• •4. Subjects with current evidence of unstable psychotic disorder, major depressive disorder, bipolar disorder, or generalized anxiety disorder based on a psychiatric interview at Screening, or subjects diagnosed with psychotic disorder or major depressive disorder within 2 years before Screening based on clinical history
• •5. Subjects on strong cytochrome P450 (CYP) 3A inducers other than AEDs (eg, rifampin, St. John's Wort)
• •6. Subjects on EIAEDs: carbamazepine, oxcarbazepine, and phenytoin or eslicarbazepine (presumed EIAED)
• •7. Using a prescription or over the counter medication for the purpose of treating sleep disturbance, including sedating antihistamines, within 14 days before dosing
• •8. Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or planning to travel across more than 3 time zones during the study
• •9. Excessive caffeine use (defined as more than 4 cups of coffee a day, or its equivalent)
• •10. Shift workers, defined as subjects who typically start work hours after 16:00 (4 pm) or before 4:00 (4 am)
• •11. Any history of a medical condition or concomitant medical condition that in the opinion of the investigator(s) would compromise the subject's ability to safely complete the study, including significantly abnormal laboratory results or any physical or mental condition that prevents compliance with the protocol
• •12. Use of illegal recreational drugs or recent history (within 2 years before the Screening Visit) of alcohol or drug/solvent dependency or abuse or a positive screen for drugs of abuse using a standard Urine Drug Screen at Screening
• •13. A clinically significant electrocardiogram (ECG) abnormality, including a prolonged QT interval/corrected QT interval defined as more than 450 msec based on an ECG at Screening
• •14. Currently enrolled in another clinical study or participated in any clinical study with an investigational drug, biologic, or device within 1 month before Screening (Visit 1), or within approximately 5 half-lives of the previous investigational compound, whichever is longer
• •15. Previous use of perampanel or participated in previous perampanel studies
• •16. Any suicidal ideation with intent with or without a plan at Screening or Baseline or within 6 months before Screening (ie, answering 'Yes' to questions on the Suicidal Ideation section of the electronic version of the Columbia Suicide Severity Rating Scale \[eC-SSRS\])
• •17. Suicide attempt(s) within approximately the last 2 years or suicidal ideation within the last 6 months before the Screening visit (using the Suicidal Behavior Section of the eC-SSRS)
• •18. Evidence of significant active hepatic disease. Stable elevations of liver enzymes, alanine aminotransferase and aspartate aminotransferase due to concomitant medication(s) will be allowed if they are less than 3 times the upper limit of normal
• •19. Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject's safety or interfere with the study assessments
• •20. Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
• •21. Presence of an implanted vagal nerve stimulator
• •22. Have had multiple drug allergies or a severe drug reaction to an AED, including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity