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Antiepileptic

Perampanel for Seizures

Phase 1 & 2

Waitlist Available

Led By Jong Woo Lee, MD, PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial will test whether the anti-seizure drug Perampanel can help prevent seizures in people with primary brain tumors.

Eligible Conditions

Seizures
Surgery
Malignant Glioma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You can participate in this trial if you had cancer before, but it will not affect the safety or effectiveness of the investigational treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of high frequency oscillations

Secondary outcome measures

Seizure-free rates

Side effects data

From 2021 Phase 4 trial • 54 Patients • NCT03288129

28%

Dizziness

17%

Fatigue

15%

Somnolence

11%

Vomiting

Nasopharyngitis

Irritability

Headache

Nausea

Ear infection

Upper respiratory tract infection

Balance disorder

Memory impairment

Aggression

Depression

Oropharyngeal pain

Mental status changes

Sudden unexplained death in epilepsy

Transient ischaemic attack

Suicidal ideation

100%

80%

60%

40%

20%

Study treatment Arm

Perampanel 12 mg

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PerampanelExperimental Treatment1 Intervention

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.

Group II: Standard of CareActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Perampanel

2014

Completed Phase 4

~2890

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eisai Inc.Industry Sponsor

515 Previous Clinical Trials

154,008 Total Patients Enrolled

26 Trials studying Seizures

6,199 Patients Enrolled for Seizures

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,936 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,655 Total Patients Enrolled

5 Trials studying Seizures

223 Patients Enrolled for Seizures

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other existing research projects that also look at Perampanel?

"Currently, there are 28 Perampanel trials underway with 2 in Phase 3. Most of these clinical trials are based in Brisbane, Queensland; though, there are a total of 132 research sites."

Answered by AI

What is the largest number of people that can join this clinical trial?

"That is correct, the clinical trial listed on clinicaltrials.gov currently has an open call for 20 participants at 1 location. The study was first posted on November 5th, 2020 and last updated July 21st, 2022."

Answered by AI

Are researchers looking for more participants in this trial?

"This trial, the details of which are available on clinicaltrials.gov, is looking for participants. The listing was created on November 5th 2020 and updated as recently as July 21st 2022."

Answered by AI

What are Perampanel's most successful applications?

"Perampanel is frequently used to treat juvenile myoclonic epilepsy in patients that weigh more than 20kg. This medication can also be prescribed for other conditions, such as various types of epileptic seizures and myoclonic seizures."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Perampanel on Peritumoral Hyperexcitability in HGG

Jong Woo Lee, MD PhD 2020. "Effect of Perampanel on Peritumoral Hyperexcitability in HGG". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04497142.