Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia (PKiDs)

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 42

Inclusion Criteria

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

Exclusion Criteria

•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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: <br>There are 2 primary objectives in this trial: <br><br>To assess the safety and tolerability after administration of single ascending oral doses of eplivanserin to children aged 6-17 years with insomnia of various origins.<br><br>To assess the pharmacokinetics of eplivanserin (and active metabolite: SR141342) after administration of single ascending oral doses of eplivanserin to children aged 6-17 years with insomnia of various origins.<br><br>;Secondary Objective: To assess the effect of single ascending oral doses of eplivanserin on global sleep parameters and sleep architecture measured via polysomnography recordings in children aged 6-17 years old with insomnia of various origins;Primary end point(s): •Safety based on adverse events, laboratory tests, vital signs, ECGs <br>•Pharmacokinetics parameters ;Timepoint(s) of evaluation of this end point: Up to 12 days following single dose administration<br>on Day 1, Day 2, Day 5, Day 7 and Day 10

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Global sleep parameters <br>•Sleep architecture;Timepoint(s) of evaluation of this end point: •Immediately following single dose administration<br>