Clinical Trials

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.
• Subject presents with MRI evidence of a primary brain tumor suspected to be due to a glioma.
• Body weight ≥ 40 kg to ≤ 125 kg.
• Established clinical diagnosis of focal epilepsy.
• No suicidal attempts or active suicidality as determined by principal or co-investigator.
• Resective surgery acceptable if baseline evaluation and perampanel are initiated post-operatively.
• Adults ages 18 and older.

Exclusion Criteria:

• Subject has serious cardiac (recent angina < 3 months), respiratory (continuous oxygen therapy) or general medical condition (i.e., previously undiagnosed rash or autoimmune disease).
• History of status epilepticus in the 6 months prior to screening or a history of seizure clusters progressing to status epilepticus.
• Clinically significant suicide risk (e.g., suicide attempt in the past 5 years or active suicidality as judged by the clinician).
• Present drug abuse or positive UDS of illegal compounds.
• If female, pregnancy confirmed by a positive pregnancy test, or is breastfeeding at screening.
• Subject has a prior exposure to perampanel.
• Prior felony conviction or violent behavior present in historical review.
• Clinically significant laboratory abnormality, at screen or baseline visits, as determined by the investigators that would interfere with the study.
• Current or previous use of an investigational drug or device within 30 days prior to treatment baseline.
• Repeated radiation therapy for known tumor regrowth.