A Randomized, Open-Label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Single and Multiple Doses of Armodafinil (50, 100, and 150 mg/Day) in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

Teva Branded Pharmaceutical Products R&D, Inc.24 个研究点分布在 2 个国家目标入组 40 人开始时间: 2012年7月最近更新: 2021年11月9日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Teva Branded Pharmaceutical Products R&D, Inc.
入组人数: 40
试验地点: 24
主要终点: Predicted accumulation ratio

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with excessive sleepiness associated with narcolepsy.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 6 Years 至 17 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Written informed consent is obtained from each patient's parent or legal guardian and written assent is obtained from each patient.
•The patient is a male or female 6 through 17 years of age with a body mass index (BMI) equal to or greater than 10th percentile for age and gender, inclusive.
•The patient has a diagnosis of narcolepsy with cataplexy or narcolepsy without cataplexy according to the criteria established by the International Classification of Sleep Disorders (ICSD)-2 for narcolepsy.

排除标准

•The patient has any clinically significant uncontrolled medical condition (treated or untreated) other than narcolepsy.
•The patient has a clinically significant deviation from normal in ECG, physical examination or vital sign findings, as determined by the investigator or medical monitor.
•The patient is pregnant or lactating. (Any patient becoming pregnant during the study will be withdrawn from the study)
•The patient has any history of seizures, including febrile seizures, or a family history of seizures (in parents or siblings) which is not a consequence of trauma, stroke, or metabolic disturbance.
•The patient has a history of head trauma associated with loss of consciousness.
•The patient has current suicidal ideation, a history of a suicidal ideation, or a history of a suicide attempt.
•The patient has a history of major depressive disorder, bipolar disorder, other significant mood disorders, schizophrenia and other psychotic disorders, eating disorders, or has a family history of suicide.
•The patient has left ventricular hypertrophy or the patient has mitral valve prolapse and has experienced mitral valve prolapse syndrome.
•The patient has received any investigational drug within 30 days or 5 half-lives (whichever is longer) before the 1st dose of study drug, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before the 1st dose of study drug.
•The patient has used any monoamine oxidase inhibitors (MAOIs) or stimulants within 14 days or 5 half-lives (whichever is longer) of the baseline visit.
•The patient has used modafinil or armodafinil within 4 weeks of the baseline visit.
•The patient has used an inducer of CYP3A4/5 within 28 days prior to study drug administration.
•The patient has used an inhibitor of CYP3A4/5 within 14 days or 5 half lives (whichever is longer) prior to study drug administration.
•The patient has a known sensitivity or idiosyncratic reaction to any compound present in modafinil or armodafinil, their related compounds, or to any metabolites or compound listed as being present in these medications.
•The patient has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions
•Other criteria apply, please contact the investigator for additional information

研究组 & 干预措施

Armodafinil 50 mg

Experimental

In period 1, patients will receive a single 50-mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose daily on days 1 through 42.

干预措施: Armodafinil (Drug)

Armodafinil 100 mg

Experimental

In period 1, patients will receive a single 100 mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose on day 1 then daily 100-mg doses on days 2 through 42.

干预措施: Armodafinil (Drug)

Armodafinil 150 mg

Experimental

In period 1, patients will receive a single 150-mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose on day 1, 100-mg doses on days 2 and 3, then daily 150-mg doses on days 4 through 42.

干预措施: Armodafinil (Drug)