Clinical trial NCT04650204: Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Intractable Epilepsy
Malignant Glioma
Seizure Disorder
WHO Grade 2 Glioma
WHO Grade 3 Glioma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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)
timeFrame: At 3 months
measure: 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
timeFrame: At 6 months
measure: Number of Participants Alive at 3 Months With High-grade Glioma Treated With PER
timeFrame: At 3 months
measure: Decline in Neuropsychological Function
timeFrame: At 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: William Tatum
role: PRINCIPAL_INVESTIGATOR
References: