Correlation of Serum Level of Perampanel (PER) Level to Cerebrospinal Fluid (CSF) Levels of PER

Study Overview
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Brief Summary
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Perampanel is a drug used to treat patients with epilepsy/seizures. This study is designed to determine how much perampanel actually crosses the blood brain barrier into the cerebral spinal fluid when the drug is taken.

Detailed Description
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Perampanel is a drug used to treat patients with epilepsy/seizures. This study is designed to determine how much perampanel actually crosses the blood brain barrier into the cerebral spinal fluid when the drug is taken. During a routinely scheduled neurosurgical procedure, one to two mL of cerebral spinal fluid will be obtained from the subarachnoid space of the brain. Five mL of arterial blood will also be drawn from the patients arterial line during their procedure. The blood samples and cerebral spinal fluid samples will be compared to see how much perampanel is in the blood versus the cerebrospinal fluid.

Official Title
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Correlation of Serum Level of Perampanel (PER) Level to Cerebrospinal Fluid (CSF) Levels of PER

Conditions
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Epilepsy, Seizures

Intervention / Treatment
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* Drug: Perampanel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (>18 years-old) who are scheduled to undergo brain surgery and need antiepileptic medication for prophylaxis or treatment of seizures Able to provide informed consent Exclusion Criteria: Patient unable to provide informed consent Allergy to PER or its component Patient with significant renal (creatinine clearance 35 ml/min) or hepatic impairment Pregnant or lactating females will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group one<br>The Group 1 patients will be taking PER up to 14 days following surgical intervention as per discretion of the treating neurosurgeon. | Drug: Perampanel<br>* For group 1 the PER dose will be administered 2-14 hours prior to sample collection. They will be administered a single dose of PER (8 mg, 12 mg or 16 mg) followed by 4 mg/day for 14 days starting on postoperative day 1 (if continued prophylaxis with PER is needed). It is anticipated that patients in group 2 will have the daily dose of PER in these individuals will range from 4 - 12 mg/day.<br>|
| Experimental: Group Two<br>The Group 2 patients will be taking PER as part of their maintenance AED regimen and will continue on the same maintenance dosage postoperatively. | Drug: Perampanel<br>* For group 1 the PER dose will be administered 2-14 hours prior to sample collection. They will be administered a single dose of PER (8 mg, 12 mg or 16 mg) followed by 4 mg/day for 14 days starting on postoperative day 1 (if continued prophylaxis with PER is needed). It is anticipated that patients in group 2 will have the daily dose of PER in these individuals will range from 4 - 12 mg/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood brain barrier serum levels | To determine the blood brain barrier(BBB) penetration of PER by measuring ratio of serum level to that of CSF measured on simultaneously obtained samples | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perampanel