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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
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
Patients with established clinical diagnoses of biopsy-proven high-grade glioma and epilepsy refractory to at least 1, drug with a seizure frequency of at least 1 seizure episode per month prior to baseline visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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

Eligibility Criteria

Inclusion Criteria

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

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%
Irritability
9%
Nasopharyngitis
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%
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

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

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
3,154 Previous Clinical Trials
3,533,986 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,575 Previous Clinical Trials
41,224,174 Total Patients Enrolled
William TatumPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
20 Total Patients Enrolled

Frequently Asked Questions

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

How extensive is the participant pool for this experiment?

"Affirmative. As per the information available on clinicaltrials.gov, this medical trial is in the process of recruiting patients with a start date of April 30th 2020 and most recent update being November 22nd 2021. The study requires 40 participants to be enrolled at one site."

Answered by AI

Are there any opportunities for recruitment of participants in this medical experiment?

"Affirmative. According to the clinicaltrials.gov listing, this trial is currently enrolling participants that were first posted on April 30th 2020 and last updated November 22nd 2021. The research requires 40 patients from a single medical site."

Answered by AI

What therapeutic applications is Perampanel employed for?

"Perampanel is a popular choice to alleviate anxiety. It can also help with partial seizures that secondary generalize, and those struggling with restless leg syndrome (RLS)."

Answered by AI

To what extent does Perampanel present a risk to individuals?

"Our assessment of the safety profile for Perampanel ranks it a 3, as this medication has already been validated in Phase 4 trials and approved for public use."

Answered by AI
~1 spots leftby Feb 2025