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

NCT04650204 | Terminated Phase 4 Results FDA Drug

• 3 other identifiers: 19-006286NCI-2020-01290MC2072
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Intractable Epilepsy; Malignant Glioma; Seizure Disorder; WHO Grade 2 Glioma; WHO Grade 3 Glioma

Outcome Measures

Primary Outcomes (4)

• 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)

  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.

  At 3 months

• 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

  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.

  At 6 months

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

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

  At 3 months

• Decline in Neuropsychological Function

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

  At 6 months

Study Arms (2)

Arm A (perampanel)

EXPERIMENTAL

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

Drug: Perampanel; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm B (ASD)

ACTIVE COMPARATOR

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

Drug: Anticonvulsant Agent; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Anticonvulsant Agent DRUG

Given ASD

Also known as: Anti-seizure agent, anticonvulsant, Anticonvulsant Agents, Anticonvulsants, antiepileptic, Antiepileptic Agent, Antiepileptics

Arm B (ASD)

Perampanel DRUG

Given PO

Also known as: E2007, Fycompa

Arm A (perampanel)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (perampanel); Arm B (ASD)

Questionnaire Administration OTHER

Ancillary studies

Arm A (perampanel); Arm B (ASD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Glioma; Epilepsy

Interventions

Anticonvulsants; perampanel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

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.

Results Point of Contact

• Title: William Tatum, D.O.
• Organization: Mayo Clinic

Tatum.William@mayo.edu

507 284-2511

Study Officials

• William Tatum

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: December 2, 2020
• Study Start: December 4, 2020
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-05

Locations

US (1)