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Anticonvulsant Agent

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

Phase 4
Waitlist Available
Led By William Tatum
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial studies how well perampanel works in reducing seizures in adults with high-grade brain tumors and specific types of epilepsy. Perampanel is a new drug approved for treating certain types of seizures. The study compares perampanel with other anti-seizure drugs to see which is more effective.

Eligible Conditions
  • Brain Tumor
  • Brain Cancer
  • Epilepsy
  • Malignant Glioma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Decline in Neuropsychological Function
Number of Participants Alive at 3 Months With High-grade Glioma Treated With PER
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
+1 more

Side effects data

From 2021 Phase 4 trial • 54 Patients • NCT03288129
28%
Dizziness
17%
Fatigue
15%
Somnolence
11%
Vomiting
9%
Nasopharyngitis
9%
Headache
9%
Irritability
7%
Nausea
7%
Ear infection
6%
Upper respiratory tract infection
6%
Balance disorder
6%
Memory impairment
6%
Aggression
6%
Depression
6%
Oropharyngeal pain
2%
Sudden unexplained death in epilepsy
2%
Transient ischaemic attack
2%
Mental status changes
2%
Suicidal ideation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Perampanel 12 mg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (perampanel)Experimental Treatment3 Interventions
Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (ASD)Active Control3 Interventions
Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perampanel
2014
Completed Phase 4
~2890

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,957 Total Patients Enrolled
22 Trials studying Epilepsy
1,070 Patients Enrolled for Epilepsy
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,113 Total Patients Enrolled
1 Trials studying Epilepsy
100 Patients Enrolled for Epilepsy
William TatumPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
20 Total Patients Enrolled
~1 spots leftby Dec 2025
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