Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy
Condition: Intractable Epilepsy; Malignant Glioma; Seizure Disorder; WHO Grade 2 Glioma; WHO Grade 3 Glioma
MeSH terms: Glioma; Epilepsy; Seizures; Epilepsies, Partial; Drug Resistant Epilepsy
Intervention: Anticonvulsant Agent; Perampanel; Quality-of-Life Assessment; Questionnaire Administration
Intervention description: Given ASD; Given PO; Ancillary studies; Ancillary studies
Intervention MeSH terms: Anticonvulsants
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase IV trial studies the side effects and how well perampanel works in reducing
      seizure frequency in patients with high-grade glioma and focal epilepsy. Perampanel is a drug
      used to treat seizures. Giving perampanel together with other anti-seizure drugs may work
      better in reducing seizure frequency in patients with high-grade glioma and focal epilepsy
      compared to alternate anti-seizure drugs alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject, or the subject's legally acceptable representative is willing to
             participate in a clinical trial, provides written informed consent, and subject
             provides written assent, as required by the Mayo Clinic Institutional Review Board
             (IRB) policy involving human subjects. In the event of subject lacking the capacity or
             losing the ability to consent, consent will be deferred to subject's legally
             acceptable 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 seizure
                  frequency 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, 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