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Anticonvulsant Agent

Perampanel for Low Grade Glioma

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

Study Summary

This trial studies the side effects of perampanel and how well it works in reducing seizure frequency in patients with high-grade glioma and focal epilepsy.

Eligible Conditions
  • Low Grade Glioma
  • Gliomas
  • 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
Irritability
9%
Headache
7%
Nausea
7%
Ear infection
6%
Upper respiratory tract infection
6%
Balance disorder
6%
Memory impairment
6%
Aggression
6%
Depression
6%
Oropharyngeal pain
2%
Mental status changes
2%
Sudden unexplained death in epilepsy
2%
Transient ischaemic attack
2%
Suicidal ideation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Perampanel 12 mg

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
3,242 Previous Clinical Trials
3,773,745 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,359 Total Patients Enrolled
William TatumPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
20 Total Patients Enrolled
~1 spots leftby Jun 2025
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