Correlation of Serum Level of Perampanel (PER) Level to Cerebrospinal Fluid (CSF) Levels of PER
试验速览
- 阶段
- 4 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Blood brain barrier serum levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Group one
The Group 1 patients will be taking PER up to 14 days following surgical intervention as per discretion of the treating neurosurgeon.
干预措施: Perampanel (Drug)
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.
干预措施: Perampanel (Drug)
结局指标
主要结局
Blood brain barrier serum levels
时间窗: 3 weeks
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
次要结局
未报告次要终点
研究者
Aashit Shah
Chief of Neurology
Carilion Clinic