Assessment of the Pharmacokinetics of Circadin® in Children With Neurodevelopmental Disorders and Sleep Disturbances
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
There is increasing evidence that chronic sleep disorders in children with autism spectrum
disorder (ASD), Angelman Syndrome (AS) and Smith-Magenis syndrome (SMS) are associated with
disturbed melatonin secretion and melatonin administration has been shown to be effective in
these populations. For children who have difficulties swallowing a tablet, Neurim has
developed an age-appropriate Melatonin formulation in the form of mini-tablets which have the
same dissolution profile as the Circadin® tablets product, thus should produce the same
melatonin concentration-time profile with the same effects. This study concerns the
pharmacokinetic study.
The purpose of this study is to :
- Establish the 24 hour baseline profile of endogenous saliva melatonin concentrations and
urine 6-SMT excretion in children aged 2 up to and including 17 years with
neurodevelopmental disorders with sleep disturbances.
- Establish the concentration-time profile of saliva melatonin concentrations and 24 hour
6-SMT urine excretion after 2 and 10 mg Circadin® mini-tablets single dose
administration in children aged 2 up to and including 17 years with neurodevelopmental
disorders with sleep disturbances.
- Evaluate the adverse event profile after a single dose of 2 or 10 mg Circadin®
mini-tablets in children aged 2 up to and including 17 years with neurodevelopmental
disorders with sleep disturbances.