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A Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Circadin® to Alleviate Sleep Disturbances in Children with Neurodevelopmental Disabilities

Principal Investigator:

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.

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