EUCTR2012-005510-20-FI进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients are included in the study if all of the following criteria are met:
- •(a) Written informed consent is obtained from each patient’s parent or legal guardian and written
- •assent is obtained from each patient.
- •(b) The patient is male or female 6 through 17 years of age with a body mass index (BMI) equal or greater than 10th percentile for age and gender, inclusive.
- •(c) 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 (347.0).
- •d) The patient is able to swallow 3 placebo tablets that match the armodafinil tablets to be
- •administered during the study with up to 240 mL of water within 5 minutes.
- •(e) The patient is in good health as determined by a medical and psychiatric history, physical
- •examination, ECG, and clinical laboratory tests.
- •(f) Inclusion criterion (f) is replaced by (f1)
- •(f1) Female patients who are postmenarche or sexually active or who are 10 years of age or older,
- •must have a negative pregnancy test prior to the baseline visit, must be using an acceptable method
- •of contraception, and agree to continued use of this method for the duration of the study and for
- •30 days after discontinuation of study drug. Acceptable methods of contraception include
- •abstinence or an intrauterine device (known to have a failure rate of less than 1% per year).
- •(g) The patent has a negative alcohol test and urine drug screen (UDS).
- •(h) The patient and parent/legal guardian must be willing and able to comply with study restrictions
- •and to remain at the clinic for the required duration at each visit.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 45
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •The patient has
- •-any clinically significant uncontrolled medical condition other than narcolepsy.
- •-clinically significant deviation from normal in ECG, physical examination or vital sign findings as determined by the investigator or medical monitor
- •-patient is pregnant or lactating
- •patient has
- •-any history of seizures, including febrile seizures, or a family history of seizures which is not a consequence of trauma, stroke, or metabolic disturbance.
- •-history of head trauma associated with loss of consciousness
- •-current suicidal ideation, history of suicidal ideation, or history of suicide attempt.
- •-history of major depressive disorder, bipolar disorder, other significant mood disorders, schizophrenia and other psychotic disorders, eating disorders or has family history of suicide.
- •-left ventricular hypertrophy or patient has mitral valve prolapse and has experienced mitral valve prolapse syndrome
- •-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 1st dose of study drug
- •-used any monoamine oxidase inhibitors or stimulants within 14 days or 5 halflives (whichever is longer) of the baseline visit
- •-used modafinil or armodafinil within 4 weeks of the baseline visit
- •-used inducer of cytochrome P450 enzyme 3A4/5 within 28 days prior to study drug administration
- •-used inhibitor of CYP3A4/5 within 14 days or 5 halflives (whichever is longer) prior to study drug administration
- •-habitually consumed, within past 12 month, more than 21 units of alcohol per week, or has history of alcohol, narcotic, or any other substance abuse as defined by the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision (DSM-IV-TRAmerican Psychiatric Association 2000).
- •-any disorder that may interfere with drug absorption, distribution, metabolism, or excretion
- •-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
- •-history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions
- •-donated blood or had significant blood loss within 56 days prior to 1st dose of study drug
- •-donated plasma within 7 days prior to the 1st dose of study drug
- •-1 or more clinical laboratory test values outside the range specified below, or any other clinically significant laboratory abnormality as determined by the investigator or medical monitor:
- •hemoglobin value of less than 11.0 g/dL, aspartate aminotransferase or alanine aminotransferase value more than twice the upper limit of the normal range (ULN), total bilirubin value of more than the ULN
- •-had a clinically significant excessive consumption of coffee, tea, and/or other
- •caffeine-containing beverage or food within 2 weeks before 1st dose of study drug, consumption
- •of 600 mg of caffeine or more per day (eg, twelve 12-ounce caffeinated sodas, 30 ounces of
- •chocolate, or 5 or more cups of coffee per day)
- •-had, within 4 weeks before 1st dose of study drug, clinically significant illness or, within 1 week before 1st dose of study drug, has had any acute illness, or at screening or on the day before 1st study drug administration, has symptoms of any clinically significant
研究者
相似试验
进行中（未招募）
不适用
A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)EUCTR2010-018418-53-FRovartis Pharma Service AG10
进行中（未招募）
不适用
A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)EUCTR2010-018418-53-DEovartis Pharma Service AG10
已完成
不适用
A non-randomized, open-label study to characterize the pharmacokinetcs of Glivec/Gleevec (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) or other Glivec/Gleevec® indicated hematological disorders.Chronic Myeloid Leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia10024324NL-OMON34200ovartis2
进行中（未招募）
不适用
A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) or other Glivec/Gleevec® indicated hematological disorderschronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)MedDRA version: 12.1Level: LLTClassification code 10009015Term: Chronic myeloid leukemiaMedDRA version: 12.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaEUCTR2010-018418-53-NLovartis Pharma Service AG10
进行中（未招募）
不适用
A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) or other Glivec/Gleevec® indicated hematological disorders - N/Achronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) or other imatinib indicated hematological disordersMedDRA version: 12.1Level: LLTClassification code 10009015Term: Chronic myeloid leukemiaMedDRA version: 12.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaEUCTR2010-018418-53-HUovartis Pharma Service AG10