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Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents

Autism Spectrum Disorder Clinical Trial

Official title:
Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents

Clinical Trial Summary

Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents.

Clinical Trial Description

This study is an open-label, single dose, non-controlled study to evaluate the PK and safety of tasimelteon in children and adolescents from 3 years to less than 18 years of age who were legally blind and met the diagnostic criteria for CRSWD Non-24 per DSM-V or who were diagnosed with a Neurodevelopmental Disorder (like ASD and SMS) and had a nighttime sleep complaint. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02776215
Study type Interventional
Source Vanda Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date October 4, 2016
Completion date December 20, 2017
View Details
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