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

Last updated: September 8, 2021
Sponsor: Carilion Clinic
Overall Status: Active - Recruiting

Phase

4

Condition

Epilepsy

Treatment

N/A

Clinical Study ID

NCT04118829
IRB-19-347
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults (>18 years-old) who are scheduled to undergo brain surgery and needantiepileptic medication for prophylaxis or treatment of seizures
  • Able to provide informed consent

Exclusion

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.

Study Design

Total Participants: 25
Study Start date:
November 01, 2019
Estimated Completion Date:
March 31, 2023

Study 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.

Connect with a study center

  • Carilion Clinic

    Roanoke, Virginia 24016
    United States

    Active - Recruiting

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