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Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy | Clinical Trials | Clareo Health

TERMINATEDPHASE4

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

NCT04650204•Mayo Clinic

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subject, or the subject's legally acceptable representative is willing to participate in a clinical trial, provides written informed consent, and subject provides written assent, as required by the Mayo Clinic Institutional Review Board (IRB) policy involving human subjects. In the event of subject lacking the capacity or losing the ability to consent, consent will be deferred to subject's legally acceptable representative
•Subjects that meet the following diagnostic criteria:
•* Patients with established clinical diagnoses of biopsy-proven high-grade glioma (grade II or above) and epilepsy refractory to at least 1, drug with a seizure frequency of at least 1 seizure episode per month prior to baseline visit
•Subjects with body weight of \>= 40 kg and =\< 125 kg at screening
•Adults age 18 and older

Exclusion Criteria

•Subject has serious cardiac, respiratory, renal, gastrointestinal, hematologic, or other medical condition as determined by the investigator to potentially interfere with the study
•Subjects with glioblastoma not following Stupp protocol for treatment of glioblastoma
•History of status epilepticus in the 6 months prior to screening or a history of seizure clusters progressing to status epilepticus
•Past medical history of drug and/or alcohol abuse
•Pregnant or breast-feeding
•Subjects treated with PER prior to baseline
•Prior felony conviction disclosed by the patient or previously stated in medical record
•History of violent behavior
•Clinically significant laboratory abnormality at screening or baseline visits, as determined by the investigators
•Use of an investigational drug or device within 20 days prior to treatment day 1
+4 more criteria

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Key Dates

Start Date

December 4, 2020

Primary Completion Date

April 30, 2023

Completion Date

April 30, 2023

Last Updated

June 22, 2023

Enrollment

ACTUAL participants

Conditions

Intractable EpilepsyMalignant GliomaSeizure DisorderWHO Grade 2 GliomaWHO Grade 3 Glioma

Interventions

Anticonvulsant Agent

DRUG

Perampanel

DRUG

Quality-of-Life Assessment

OTHER

Questionnaire Administration

OTHER

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

NCT05099003

Malignant Glioma

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RECRUITINGEARLY_PHASE1

Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma

NCT05717153

Diffuse GliomaMalignant Glioma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma

Network Effects of Therapeutic Deep Brain Stimulation

Electrochemical and Electrophysiological Study

BGB-290 and Temozolomide in Treating Isocitrate Dehydrogenase (IDH)1/2-Mutant Grade I-IV Gliomas

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)