Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
Given the potential age-related differences in safety, tolerability, pharmacokinetics, and
differences in sleep architecture in young children versus adolescent versus adult, studies
to identify the appropriate drug and dosage for children of all ages are essential in
addressing this health problem that impacts the child and their family. The objective of this
study is to evaluate the safety, pharmacokinetics and preliminary efficacy of eplivanserin.
Primary objective: 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.
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.
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.