Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Intractable Epilepsy
- Malignant Glioma
- Seizure Disorder
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. Demonstrate the efficacy and safety of perampanel (PER) on seizure frequency in adult patients with biopsy-proven high-grade glioma and focal epilepsy compared with alternate anti-seizure drugs (ASDs). SECONDARY OBJECTIVES: I. To assess the change in neurocognitive function and...
PRIMARY OBJECTIVE: I. Demonstrate the efficacy and safety of perampanel (PER) on seizure frequency in adult patients with biopsy-proven high-grade glioma and focal epilepsy compared with alternate anti-seizure drugs (ASDs). SECONDARY OBJECTIVES: I. To assess the change in neurocognitive function and brain magnetic resonance imaging (MRI) progression over the course of PER treatment with a daily dose of 4 mg (up to -8mg) in patients with biopsy-proven high-grade glioma and focal epilepsy compared with alternate ASDs. II. To identify a biomarker-specific response to seizure-reduction in patients treated with PER in patients with a biopsy-proven high-grade glioma (i.e., IDH-mutant versus [vs] wildtype). OUTLINE: Patients are assigned to 1 of 2 groups. GROUP A: Patients receive perampanel orally (PO) once daily (QD) 40 weeks in the absence of disease progression or unacceptable toxicity. GROUP B: Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 12 months.
Tracking Information
- NCT #
- NCT04650204
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: William Tatum Mayo Clinic