Efficacy and Safety of Slenyto for Insomnia in Children With ASD
Status:
Withdrawn
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
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.