Pharmacokinetics of Anti-epileptic Drugs in Obese Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 10
- 主要终点
- Steady-state pharmacokinetics area under the curve
研究概览
简要总结
The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to characterize the pharmacokinetics and safety of four oral anti-epileptics drugs (levetiracetam, valproic acid [divalproex sodium ER or immediate release formulation if inadequate enrollment}, topiramate, and oxcarbazepine) in a non-randomized sample of obese children and adolescents. The study's duration will be up to eleven days (up to seven days of screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18 years will be identified through outpatient clinic schedules and inpatient admissions at each clinic site. Participants receiving at least one of the study drugs per local standard of care will have pharmacokinetic concentrations in plasma drawn according to the specific dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip ratio, medical history, concomitant medication history, documentation of study drug oral intake, adverse effects, and physical examination. The sample size will include 24 participants for each anti-epileptic drug (total 96).
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
- 2 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2 years to < 18 years at the time of enrollment
- •BMI ≥ 95th percentile for age and sex, based on CDC recommendations
- •Informed consent/HIPAA from the parent/legal guardian and assent (as applicable)
- •Receiving ≥ 1 of the study drugs per local standard of care
排除标准
- •Known pregnancy as determined via interview or test results, if available
结局指标
主要结局
Steady-state pharmacokinetics area under the curve
时间窗: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics maximum concentration
时间窗: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics time to reach maximum concentration
时间窗: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics oral apparent volume of distribution
时间窗: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics half life
时间窗: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics oral apparent clearance
时间窗: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics absorption rate constant
时间窗: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
次要结局
- Serious adverse events(Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling))
研究者
Christoph P Hornik, MD MPH
Associate Professor of Pediatrics
Duke University
