Correlation of Serum Level of Perampanel (PER) Level to Cerebrospinal Fluid (CSF) Levels of PER
NCT ID: NCT04118829
Last Updated: 2021-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
25 participants
INTERVENTIONAL
2019-11-01
2023-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group one
The Group 1 patients will be taking PER up to 14 days following surgical intervention as per discretion of the treating neurosurgeon.
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.
Group Two
The Group 2 patients will be taking PER as part of their maintenance AED regimen and will continue on the same maintenance dosage postoperatively.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Carilion Clinic
OTHER
Responsible Party
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Aashit Shah
Chief of Neurology
Principal Investigators
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Aashit Shah, MD
Role: PRINCIPAL_INVESTIGATOR
Physician
Locations
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Carilion Clinic
Roanoke, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-19-347
Identifier Type: -
Identifier Source: org_study_id
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