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

NCT ID: NCT04650204

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-04
• Study Completion Date: 2023-04-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm A (perampanel)

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

Group Type: EXPERIMENTAL

Perampanel

Intervention Type: DRUG

Given PO

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Arm B (ASD)

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

Group Type: ACTIVE_COMPARATOR

Anticonvulsant Agent

Intervention Type: DRUG

Given ASD

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Anticonvulsant Agent

Given ASD

Intervention Type: DRUG

Perampanel

Given PO

Intervention Type: DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Anti-seizure agent; anticonvulsant; Anticonvulsant Agents; Anticonvulsants; antiepileptic; Antiepileptic Agent; Antiepileptics; E2007; Fycompa; Quality of Life Assessment

Eligibility Criteria

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
• Repeated radiation therapy for tumor regrowth
• Subjects that plan to undergo tumor resection on or after baseline visit
• Uncontrolled psychiatric disorder at baseline
• Subjects who report active suicidal attempts or suicidality including subjects with a history of suicide attempts or suicidality determined to be clinically significant by investigators at screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

William Tatum, DO

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Tatum

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2020-01290

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC2072

Identifier Type: OTHER

Identifier Source: secondary_id

19-006286

Identifier Type: -

Identifier Source: org_study_id