NCT04650204

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

A Phase IV, Prospective, Open-Label, Parallel Study Evaluating the Effect of an Adjunctive Anti-Seizure Medication Using a Glutamatergic Modulator in Patients With Focal Epilepsy and High-Grade Glioma

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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) for 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.

Conditions

• Intractable Epilepsy
• Malignant Glioma
• Seizure Disorder
• WHO Grade 2 Glioma
• WHO Grade 3 Glioma

Interventions

Type	Name	Description
DRUG	Anticonvulsant Agent	Given ASD
DRUG	Perampanel	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-12-04
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2020-12-02
• Last updated: 2023-06-22
• Results posted: 2023-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study