clinical trial · NCT02776215
Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents
Circadian Rhythm Sleep DisordersNon-24 Hour Sleep-Wake DisorderAutism Spectrum DisorderSmith-Magenis Syndrometasimelteon
brief summary
Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents.
started
Oct 4, 2016
primary completion
Dec 20, 2017
completion
Dec 20, 2017
last updated
Mar 21, 2024
detailed 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.
official title
Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol