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

Inclusion Criteria:

• The subject, or the subject's legally acceptable representative is willing toparticipate in a clinical trial, provides written informed consent, and subjectprovides written assent, as required by the Mayo Clinic Institutional Review Board (IRB) policy involving human subjects. In the event of subject lacking the capacity orlosing the ability to consent, consent will be deferred to subject's legallyacceptable representative
• Subjects that meet the following diagnostic criteria:
• Patients with established clinical diagnoses of biopsy-proven high-grade glioma (grade II or above) and epilepsy refractory to at least 1, drug with a seizurefrequency of at least 1 seizure episode per month prior to baseline visit
• Subjects with body weight of >= 40 kg and =< 125 kg at screening
• Adults age 18 and older

Exclusion Criteria:

• Subject has serious cardiac, respiratory, renal, gastrointestinal, hematologic, orother medical condition as determined by the investigator to potentially interferewith 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 ofseizure 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 medicalrecord
• History of violent behavior
• Clinically significant laboratory abnormality at screening or baseline visits, asdetermined 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 ahistory of suicide attempts or suicidality determined to be clinically significant byinvestigators at screening