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
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
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
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
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Conditions
Cancer Related
Treatments