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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04118829
• Other study ID #: IRB-19-347
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2019
• Est. completion date: March 2023

Study information

• Verified date: September 2021
• Source: Carilion Clinic
• Contact: Jordan Darden, PhD
• Phone: 540-981-7942
• Email: jadarden[@]carilionclinic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Drug:
• Perampanel
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.

Locations

Country	Name	City	State
United States	Carilion Clinic	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Carilion Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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