Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities
Status:
Completed
Trial end date:
2018-03-27
Target enrollment:
Participant gender:
Summary
The purpose of this study is to establish the efficacy and safety of Circadin in children
with neurodevelopmental disorders and to determine the dose, this randomized,
placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week
treatment period with Circadin 2/5mg in improving maintenance of sleep, sleep latency and
additional parameters in children with neurodevelopmental disabilities. The efficacy and
safety of Circadin 2/5 mg will continue to be assessed during an open-label extension period
of 13 weeks.