Perampanel for Epilepsy

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Epilepsy+2 MorePerampanel - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Epilepsy
  • Malignant Glioma
  • Intractable Epilepsy

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: At 3 months

At 3 months
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)
Overall survival of patients with high-grade glioma treated with PER
At 6 months
Decline in neuropsychological function
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

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Perampanel 12 mg
28%Dizziness
17%Fatigue
15%Somnolence
11%Vomiting
9%Irritability
9%Nasopharyngitis
9%Headache
7%Nausea
7%Ear infection
6%Depression
6%Balance disorder
6%Upper respiratory tract infection
6%Memory impairment
6%Oropharyngeal pain
6%Aggression
2%Sudden unexplained death in epilepsy
2%Transient ischaemic attack
2%Mental status changes
2%Suicidal ideation
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT03288129) in the Perampanel 12 mg ARM group. Side effects include: Dizziness with 28%, Fatigue with 17%, Somnolence with 15%, Vomiting with 11%, Irritability with 9%.

Trial Design

2 Treatment Groups

Arm B (ASD)
1 of 2
Arm A (perampanel)
1 of 2

Active Control

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Perampanel · No Placebo Group · Phase 4

Arm A (perampanel)Experimental Group · 3 Interventions: Perampanel, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Drug, Other, Other
Arm B (ASD)ActiveComparator Group · 4 Interventions: Phenobarbital, Phenytoin, Carbamazepine, Valproate, Gabapentin, Pregabalin, Lamotrigine, Topiramate, Leviteracetam, Lacosamide, Zonisamide, Clobazam, Oxcarbezepine, Rufinamide, Anticonvulsant Agent, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Drug, Drug, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perampanel
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 3 months

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,917 Previous Clinical Trials
3,507,113 Total Patients Enrolled
20 Trials studying Epilepsy
1,149 Patients Enrolled for Epilepsy
National Cancer Institute (NCI)NIH
13,068 Previous Clinical Trials
41,129,262 Total Patients Enrolled
1 Trials studying Epilepsy
100 Patients Enrolled for Epilepsy
William TatumPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
20 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a clinical diagnosis 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.
were randomized to receive placebo or IV iron sucrose (200 mg) Subjects with a body weight of 40 kg to 125 kg at screening were randomized to receive a placebo or IV iron sucrose (200 mg).
The subject 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