This phase IV trial studies how well perampanel works in lowering the incidence of seizures in patients with malignant glioma. It is common for patients with brain tumors to experience seizures. Despite taking the typically prescribed anti-seizure medication, some patients still experience seizures. Adding perampanel to typical seizure medication may help lower the number of seizures that patients experience.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02363933.
PRIMARY OBJECTIVES:
I. To determine the efficacy of perampanel as an adjunctive anti-epileptic drug (AED) in patients with primary glioma presenting refractory partial onset seizure activity.
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of perampanel as an adjunctive AED in patients with primary glioma presenting with refractory partial onset seizure activity.
TERTIARY OBJECTIVES:
I. To evaluate the effect that perampanel has on neurocognition and patient-reported outcomes of quality of life (QoL) in patients with primary glioma presenting with refractory partial onset seizure activity.
OUTLINE:
Patients receive perampanel orally (PO) once daily (QD) for 16 weeks followed by a taper for 4 weeks. Patients also continue to receive AED as they were before study enrollment.
After completion of study treatment, patients are followed up for 4 weeks.
Trial PhasePhase IV
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorKatherine B Peters
