Nervous System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Rare Diseases

Drug Resistant Epilepsy

Epilepsy

Glioma

Seizures

Epilepsies, Partial

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Brain Diseases

Central Nervous System Diseases

Neurologic Manifestations

Neuroepithelioma

Anticonvulsants

All Drugs and Chemicals

Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity.

Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity.

Anticonvulsant Agent

Perampanel

Quality-of-Life Assessment

Questionnaire Administration

William Tatum

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.

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.

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

Will compare seizure frequency before and 3 months after treatment with monotherapy and adjunctive PER and use descriptive statistics to demonstrate differences in responders. A P-value \< 0.05 will be used to reflect statistical significance.

Will compare seizure frequency before and 6 months after treatment with monotherapy and adjunctive PER and use descriptive statistics to demonstrate differences in responders. A P-value \< 0.05 will be used to reflect statistical significance.

Chi-square and Student T-test will be used to measure differences in assessment and change during the study period.

Mayo Clinic

Principal Investigator

Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity.

Perampanel: Given PO

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Arm A (Perampanel)

Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity.

Anticonvulsant Agent: Given ASD

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Arm B (ASD)

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study was terminated due to the funding sponsor(EISAI) sold the US rights to the medication and can no longer provide it to patients for the study.

William Tatum, D.O.

1 participant was randomized to Arm B, but did not complete the 3 month follow-up due to study termination. In Arm A, only 2 participants met the study 3 month mark prior to study termination.

Number of Patients With a High-grade Glioma Who Achieve a > 50% Reduction in Focal Seizures With Perampanel (PER) 4 mg Daily After Failing 1 or More Anti-seizure Drugs (ASDs)

1 participant was randomized to Arm B, but did not complete the 6 month follow-up due to study termination. In Arm A, only 1 participant met the study 6 month mark prior to study termination.

Number of Patients With a High-grade Glioma Who Achieve a > 50% Reduction in Focal Seizures With PER 4 mg Daily After Failing 1 or More ASDs

1 participant was randomized to Arm B, but did not receive PER treatment. In Arm A, only 2 participants met the study 3 month mark prior to study termination.

Number of Participants Alive at 3 Months With High-grade Glioma Treated With PER

The study was terminated due to the funding sponsor no longer being able to provide study medication. Data for this outcome measure was not collected nor analyzed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy	NCT04650204	Intractable Epi... Malignant Gliom... Seizure Disorde... WHO Grade 2 Gli... WHO Grade 3 Gli...	Anticonvulsant ... Perampanel Quality-of-Life... Questionnaire A...	18 Years -	Mayo Clinic
Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy	NCT04650204	Intractable Epi... Malignant Gliom... Seizure Disorde... WHO Grade 2 Gli... WHO Grade 3 Gli...	Anticonvulsant ... Perampanel Quality-of-Life... Questionnaire A...	18 Years -	Mayo Clinic
Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy	NCT04650204	Intractable Epi... Malignant Gliom... Seizure Disorde... WHO Grade 2 Gli... WHO Grade 3 Gli...	Anticonvulsant ... Perampanel Quality-of-Life... Questionnaire A...	18 Years -	Mayo Clinic

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