Neoplasms

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Glioma

Seizures

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neurologic Manifestations

Neuroepithelioma

Anticonvulsants

Nootropic Agents

All Drugs and Chemicals

Levetiracetam

* Participants will take a predetermined first dose of perampanel on the day before their tumor surgery
* During surgery, an approximately 4x6cm recording grid will be placed on the surface of the brain over the tumor, and brain activity around the tumor will be recorded for 10 minutes during surgery (Electrocorticography).
* After surgery participants will take perampanel at a predetermined dose once a day for as long as they do not have serious side effects and their disease does not get worse, up to a maximum of 12 months. Participants will be provided a drug and seizure diary to document drug and seizure information and have monthly study visits either in clinic or by phone.

* Participants will receive standard of care medication before surgery.
* During surgery, an approximately 4x6cm recording grid will be placed on the surface of the brain over the tumor, and brain activity around the tumor will be recorded for 10 minutes during surgery (Electrocorticography).
* After surgery participants will take standard of care medications as predetermined by their doctor. Participants will be provided a drug and seizure diary to document drug and seizure information and have monthly study visits either in clinic or by phone.
* Participants will be followed up to 12 months after completing surgery.

Perampanel

Predetermined standard of care drug and dosing

Standard of Care

Jong Woo Lee, MD, PhD

The purpose of this research study is to learn more about seizures in people with primary brain tumors. It will evaluate whether an antiseizure medication decreases hyperexcitability activity around tumors and prevents seizures.

The procedure and study drug involved in this study are:

* Electrocorticography
* Perampanel (Fycompa)

This research study is a Pilot Study, which is the first time investigators are examining brain activity after taking perampanel.

The U.S. Food and Drug Administration (FDA) has approved perampanel as a treatment option for seizures. It has not been approved for the treatment of brain tumors. Recording of brain activity (electrocorticography) during surgery is an established clinical procedure, which will be performed for investigational purposes. This research study is studying brain recordings and perampanel treatment in participants with brain tumors for the following reasons:

* People with brain tumors commonly have seizures.
* Perampanel was developed as an anti-seizure medication, which works by blocking a signaling pathway between brain cells, mediated by AMPA receptors.
* Previous research has shown abnormal brain activity around tumors resulting from increased AMPA receptor activation.
* Perampanel is expected to decrease abnormal brain activity and prevent seizures by blocking AMPA receptor signaling.

This study involves two groups of participants, one group who receives the antiseizure medication perampanel, and the other group who receives the usual antiseizure medication (typically levetiracetam) at the time of surgery. Participants have the option to choose which group to participate if they have a preference.

The research study procedures include screening for eligibility, recording brain activity during surgery, and study treatment including evaluations and follow up visits. Participants will receive the study drug for as long as they do not have serious side effects and their disease does not get worse, up to a maximum of 12 months.

It is expected that about 20 people will take part in this research study.

The National Institute of Health (NIH) is supporting this study by providing funding for the research. Eisai Inc, a pharmaceutical company, is supporting this research study by providing the study medication.

Effect of Perampanel on Peritumoral Hyperexcitability in HGG

Pilot Study of Perampanel on Peritumoral Hyperexcitability and Seizure Control in Newly Diagnosed High Grade Glioma

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Steven Tobochnik, MD at stobochnik@bwh.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The effect of perampanel on peritumoral hyperexcitability will be measured using intraoperative electrocorticography (ECoG) at the time of initial glioma resection to analyze high frequency oscillations (80-500 Hz). The rate of high frequency oscillations over 10 minutes of recording in the tumor margins will be compared between participants receiving perampanel versus standard of care treatment.

The clinical effect of perampanel maintenance therapy on seizure control will be measured by seizure-free rates between the time of initial glioma resection and radiographic tumor progression (up to a maximum of 12 months), and compared to seizure-free rates in participants receiving standard of care treatment.

National Cancer Institute (NCI)

Eisai Inc.

Dana-Farber Cancer Institute

Principal Investigator

Drug Resistant Epilepsy

Epilepsy

Epilepsies, Partial

Brain Diseases

Central Nervous System Diseases

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

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

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.

Decline in Neuropsychological Function

Overall Study

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Amino Acids

Excitatory Amino Acid Antagonists

alpha-Amino-3-hydroxy-5-methyl-4-isoxazolepropionic Acid

Glutamic Acid

Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.

Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures

Katherine B Peters, MD, PhD

This is a Phase 2 single-arm study to assess the efficacy of perampanel as an adjunctive anti-epileptic drug (AED) in patients with primary glioma that are presenting refractory partial onset seizure activity (defined as 3 or more seizures in a 28-day period). In this study, patients will be started on a dose of 2 mg of perampanel daily taken orally at bedtime for 2 weeks. At the start of week 3 perampanel will be titrated up in dose in 2mg increments per week up to 8mg daily, as long as it is well tolerated by the patient. The highest dose of perampanel will be 8 mg orally at bedtime. Once this is achieved, patients will remain on a maintenance dose of 8 mg for 12 more weeks. The planned treatment dose is 8mg, but the dose can be modified by the physician based on patient reported tolerability. Titration and taper periods will be determined by the physician in the case where patients do not reach the planned treatment dose of 8 mg daily. Patients will be assessed in the Brain Tumor Center Clinic every 8 weeks. Study assessments will be made at enrollment, 8 weeks, 16 weeks, and 24 weeks. Assessments will include history and physical examination (H\&P) including Karnofsky Performance Status (KPS), neurological examination, evaluation of seizure history, patient-reported outcomes of QoL, and computer based neurocognitive testing. After a total of 16 weeks of therapy, perampanel will be tapered down. At Week 17, patients will begin taking 6mg of perampanel, Week 18 4mg, Week 19 2mg, and Week 20 they will no longer take perampanel. Patients will be considered off treatment at the end of week 20, once perampanel has cleared their system. Patients will then be monitored through Week 24. Patients will continue to take their original AED regimen after they stop perampanel. If seizure control is achieved during the maintenance period or if seizures occur during the tapering period, patients can be continued on perampanel per the discretion of the treating physician. In this instance, perampanel will be prescribed by the treating physician and not provided within the confines of the study. Efficacy will be assessed using a log of patient-reported seizure activity. As is standard procedure at the Preston Robert Tisch Brain Tumor Center (PRTBTC), patients will be given a log to record the number of seizures that occur. Research team members will regularly contact patients for reminders and reports from the log. Safety will be assessed with the following laboratory evaluations: complete blood count (CBC) with differential, complete metabolic panel (CMP), and toxicity assessment.

This is a Phase 2 single-arm study to assess the efficacy of perampanel as an adjunctive anti-epileptic drug (AED) in patients with primary glioma that are presenting refractory partial onset seizure activity (defined as 3 or more seizures in a 28-day period). In this study, patients will be started on a dose of 2 mg of perampanel daily taken orally at bedtime for 2 weeks. At the start of week 3 perampanel will be titrated up in dose in 2mg increments per week up to 8mg daily, as long as it is well tolerated by the patient. The highest dose of perampanel will be 8 mg orally at bedtime. Once this is achieved, patients will remain on a maintenance dose of 8 mg for 12 more weeks. The planned treatment dose is 8mg, but the dose can be modified by the physician based on patient reported tolerability. Titration and taper periods will be determined by the physician in the case where patients do not reach the planned treatment dose of 8 mg daily. Patients will be assessed in the Brain Tumor Center Clinic every 8 weeks. Study assessments will be made at enrollment, 8 weeks, 16 weeks, and 24 weeks. Assessments will include history and physical examination (H\&P) including Karnofsky Performance Status (KPS), neurological examination, evaluation of seizure history, patient-reported outcomes of QoL, and computer based neurocognitive testing. After a total of 16 weeks of therapy, perampanel will be tapered for 3 weeks and then will be discontinued, such that Week 20 patients will no longer be taking perampanel. Patients will then be monitored through Week 24. Patients will continue to take their original AED regimen after they stop perampanel. Patients will remain on their original AED regimen during this treatment time and the dose of their original AED regimen at the start of the study will not be changed while they are on study. If seizure control is achieved during the maintenance period or if seizures occur during the tapering period, patients can be continued on perampanel per the discretion of the treating physician. In this instance, perampanel will be prescribed by the treating physician and not provided within the confines of the study. Efficacy will be assessed using a log of patient-reported seizure activity. As is standard procedure at the PRTBTC, patients will be given a log to record the number of seizures that occur. Research team members will regularly contact patients for reminders and reports from the log. Safety will be assessed with the following laboratory evaluations: complete blood count (CBC) with differential, complete metabolic panel (CMP), and toxicity assessment.

This study has been designed with 90% power to detect an increase in the 50% responder rate during the maintenance period from a benchmark of 20% to 35%. Assuming a type I error rate of 0.1, 61 patients will be required. Based on prior studies the early discontinuation rate was 16%, therefore 71 patients will be enrolled to compensate for patients discontinuing prior to the completion of the maintenance period.

Perampanel in Seizure Patients With Primary Glial Brain Tumors

Phase II Feasibility Study to Evaluate the Efficacy and Safety of Perampanel in Seizure Patients With Primary Glial Brain Tumors

The primary objective of this study is to assess the efficacy of perampanel as an adjunctive anti-epileptic drug (AED) in patients with primary glioma presenting refractory partial onset seizure activity. Efficacy will be assessed by the 50% responder rate, defined as the percentage of patients with a ≥50% seizure reduction during the maintenance period compared with the seizure frequency before initiation of perampanel. Seizure frequency during maintenance perampanel will be computed as the ratio of the total number of seizure episodes while receiving perampanel during the maintenance period and the number of days perampanel is administered

The percentage of patients with unacceptable adverse events that are possibly, probably, or definitely related to perampanel treatment will be calculated. Unacceptable adverse events include all Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade 4 or 5 toxicities that are possibly, probably, or definitely related to perampanel, as well as suicidal ideation (any grade) or suicide attempt (Grade 3-5).

Duke University

Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.

Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures

Perampanel + Current Anti-Epileptic Drug

Age, Continuous

Katherine Peters, MD, PhD

Seizure frequency was not systematically gathered at screening. As the 50% responder rate requires an adequate baseline comparison, it is not possible to compute the 50% responder rate.

Percentage of Patients With ≥50% Seizure Reduction During the Maintenance Period Compared With Seizure Frequency Before Initiation of Perampanel

All patients treated with perampanel is included in the attributable adverse event rate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Perampanel on Peritumoral Hyperexcitability in HGG	NCT04497142	Glioma, Maligna... Surgery Seizures	Perampanel Standard of Car...	18 Years -	Dana-Farber Cancer Institute
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 in Seizure Patients With Primary Glial Brain Tumors	NCT02363933	Brain Tumor, Pr...	Perampanel	18 Years -	Duke University
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

Spots Global Cancer Trial Database for perampanel

Every month we try and update this database with for perampanel cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for perampanel

Every month we try and update this database with for perampanel cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for perampanel cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.