Population Pharmacokinetics, Effectiveness and Safety of Antiepileptic Drugs in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The peak plasma drug concentration of antiepileptic drugs.
研究概览
简要总结
The purpose is to study the population pharmacokinetics, effectiveness and safety of antiepileptic drug (phenytoin, carbamazepine, lamotrigine, levetiracetam, parempanel, etc) in elderly patients and recommend optimized dosage regimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years old;
- •Diagnosed with epilepsy;
- •Using antiepileptic drugs for treatment;
排除标准
- •Patients who are expected to die within 48 hours;
- •Patients with allergy to antiepileptic drugs;
- •Patients receiving other investigational drugs;
- •Other factors that the researcher considers unsuitable for inclusion.
研究组 & 干预措施
Treatment
The use of antiepileptic drugs depends on the clinical practice.
干预措施: antiepileptic drugs (Drug)
结局指标
主要结局
The peak plasma drug concentration of antiepileptic drugs.
时间窗: at (0-4) h after oral administration
To detect the peak plasma drug concentration of antiepileptic drugs.
The random plasma drug concentration of antiepileptic drugs.
时间窗: at (4-10) h after oral administration
To detect the random plasma drug concentration of antiepileptic drugs.
The trough plasma drug concentration of antiepileptic drugs.
时间窗: at (1-2) h before the next administration
To detect the trough plasma drug concentration of antiepileptic drugs.
次要结局
- The frequency of seizures(Through study completion, an average of 14 days)
- The incidence of adverse drug reaction(Through study completion, an average of 14 days)
研究者
Wei Zhao
Head of department of clinical pharmacy and pharmacology
Shandong University