Perampanel in Seizure Patients With Primary Glial Brain Tumors
Status:
Completed
Trial end date:
2017-04-10
Target enrollment:
Participant gender:
Summary
This is a Phase 2 single-arm study to assess the efficacy of perampanel as an adjunctive
anti-epileptic drug (AED) in patients with primary glioma that are presenting refractory
partial onset seizure activity (defined as 3 or more seizures in a 28-day period). In this
study, patients will be started on a dose of 2 mg of perampanel daily taken orally at bedtime
for 2 weeks. At the start of week 3 perampanel will be titrated up in dose in 2mg increments
per week up to 8mg daily, as long as it is well tolerated by the patient. The highest dose of
perampanel will be 8 mg orally at bedtime. Once this is achieved, patients will remain on a
maintenance dose of 8 mg for 12 more weeks. The planned treatment dose is 8mg, but the dose
can be modified by the physician based on patient reported tolerability. Titration and taper
periods will be determined by the physician in the case where patients do not reach the
planned treatment dose of 8 mg daily. Patients will be assessed in the Brain Tumor Center
Clinic every 8 weeks. Study assessments will be made at enrollment, 8 weeks, 16 weeks, and 24
weeks. Assessments will include history and physical examination (H&P) including Karnofsky
Performance Status (KPS), neurological examination, evaluation of seizure history,
patient-reported outcomes of QoL, and computer based neurocognitive testing. After a total of
16 weeks of therapy, perampanel will be tapered down. At Week 17, patients will begin taking
6mg of perampanel, Week 18 4mg, Week 19 2mg, and Week 20 they will no longer take perampanel.
Patients will be considered off treatment at the end of week 20, once perampanel has cleared
their system. Patients will then be monitored through Week 24. Patients will continue to take
their original AED regimen after they stop perampanel. If seizure control is achieved during
the maintenance period or if seizures occur during the tapering period, patients can be
continued on perampanel per the discretion of the treating physician. In this instance,
perampanel will be prescribed by the treating physician and not provided within the confines
of the study. Efficacy will be assessed using a log of patient-reported seizure activity. As
is standard procedure at the Preston Robert Tisch Brain Tumor Center (PRTBTC), patients will
be given a log to record the number of seizures that occur. Research team members will
regularly contact patients for reminders and reports from the log. Safety will be assessed
with the following laboratory evaluations: complete blood count (CBC) with differential,
complete metabolic panel (CMP), and toxicity assessment.