Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy

Exclusion Criteria

• •Subject has serious cardiac, respiratory, renal, gastrointestinal, hematologic, or other medical condition as determined by the investigator to potentially interfere with the study
• •Subjects with glioblastoma not following Stupp protocol for treatment of glioblastoma
• •History of status epilepticus in the 6 months prior to screening or a history of seizure clusters progressing to status epilepticus
• •Past medical history of drug and/or alcohol abuse
• •Pregnant or breast-feeding
• •Subjects treated with PER prior to baseline
• •Prior felony conviction disclosed by the patient or previously stated in medical record
• •History of violent behavior
• •Clinically significant laboratory abnormality at screening or baseline visits, as determined by the investigators
• •Use of an investigational drug or device within 20 days prior to treatment day 1
• •Repeated radiation therapy for tumor regrowth
• •Subjects that plan to undergo tumor resection on or after baseline visit
• •Uncontrolled psychiatric disorder at baseline
• •Subjects who report active suicidal attempts or suicidality including subjects with a history of suicide attempts or suicidality determined to be clinically significant by investigators at screening