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

Carilion Clinic

Status and phase: Unknown; Phase 4

Conditions: Seizures; Epilepsy

Treatments: Drug: Perampanel

Study type: Interventional

Funder types: Other

Identifiers

NCT04118829

IRB-19-347

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Group one

Experimental group

Description:

The Group 1 patients will be taking PER up to 14 days following surgical intervention as per discretion of the treating neurosurgeon.

Treatment:

Drug: Perampanel

Group Two

Experimental group

Description:

The Group 2 patients will be taking PER as part of their maintenance AED regimen and will continue on the same maintenance dosage postoperatively.

Treatment:

Drug: Perampanel