Efficacy and Safety of Slenyto for Insomnia in Children With ASD

Summary

This is a randomized placebo controlled study in children diagnosed with autism spectrum disorder (ASD), to Investigate the Efficacy and Safety of Slenyto® to alleviate Sleep Disturbances in these children. . The main objective is to compare treatment effect of Slenyto® 2 mg or 5 mg to that of placebo on sleep duration (total sleep time \[TST\]) as assessed by the Sleep and Nap Diary after 3 weeks of double blind treatment.

Timeline

Start

2020-09

Primary completion

2022-09

Completion

2022-12

Drugs

Indications