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

Primary Purpose

Epilepsy, Seizures

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Perampanel
Sponsored by
Carilion Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Perampanel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Carilion ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group one

Group Two

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 16, 2019
Last Updated
September 8, 2021
Sponsor
Carilion Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04118829
Brief Title
Correlation of Serum Level of Perampanel (PER) Level to Cerebrospinal Fluid (CSF) Levels of PER
Official Title
Correlation of Serum Level of Perampanel (PER) Level to Cerebrospinal Fluid (CSF) Levels of PER
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carilion Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Seizures
Keywords
Perampanel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group one
Arm Type
Experimental
Arm Description
The Group 1 patients will be taking PER up to 14 days following surgical intervention as per discretion of the treating neurosurgeon.
Arm Title
Group Two
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Perampanel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood brain barrier serum levels
Description
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
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Darden, PhD
Phone
540-981-7942
Email
jadarden@carilionclinic.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aashit Shah, MD
Organizational Affiliation
Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Darden, PhD
Phone
540-981-7942
Email
jadarden@carilionclinic.org
First Name & Middle Initial & Last Name & Degree
Ruth Ndolo, RN
Phone
540-519-3428
Email
rmndolo@carilionclinic.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not share any individual participant data. Data analysis will involve aggregated data.

Learn more about this trial

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

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