Single dose, open label safety, tolerability, pharmacokinetic and pharmacodynamic evaluation of three different eplivanserin doses in children aged 6-17 years with insomnia of various origins

Sanofi-aventis0 个研究点目标入组 42 人开始时间: 2015年3月17日最近更新: 2015年3月23日

适应症

试验速览

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•Healthy male or female children between the ages of 6 and 17 years, inclusive (before 18th birthday) with a diagnosis of insomnia of various origins.
•Complaint of childhood insomnia as defined by repeated difficulty with sleep initiation or consolidation that occurs despite adequate age appropriate time and opportunity for sleep. The existence of sleep difficulty was supported by statements from the child and/or the caregiver that sleep was not properly initiated or maintained.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 42
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•The sleep disturbance must not be attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication.
•Subject, if female of childbearing potential, which are unwilling to abstain from sexual intercourse or practice a double contraception method for the length of the study.
•Mental retardation.
•The presence of any untreated or uncompensated clinically significant renal, endocrine, hepatic, respiratory, cardiovascular, neurologic (excluding ADHD), hematologic, immunologic, cerebrovascular disease, or malignancy.
•Subjects with a history of any significant gastrointestinal disease.
•Presence of drug or alcohol abuse within one year before inclusion.
•Current history of substance abuse/dependence.
•Pregnant or breast-feeding.
•Use of any hypnotics/psychotropics, antihistamines, melatonin, herbal products, or other sleep aids including clonidine for initiation or maintenance of sleep within one week or five half lives (whichever is longer), prior to screening and unwillingness to discontinue them at the screening visit.
•Subject tested positive at screening or at baseline or at Day 1, on urine drug screen for drugs known to alter sleep (amphetamine/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates and alcohol).
•Inability to swallow a pill in similar size as the tablets to be administered for this study.

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