Completed PHASE1 INTERVENTIONAL 1-arm NCT02776215

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

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

Sponsor: Vanda Pharmaceuticals

Conditions Autism Spectrum Disorder Circadian Rhythm Sleep Disorders Non-24 Hour Sleep-Wake Disorder Smith-Magenis Syndrome

Interventions tasimelteon

Updated 9 times since 2017 Last updated: Mar 19, 2024 Started: Oct 4, 2016 Primary completion: Dec 20, 2017 Completion: Dec 20, 2017

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Autism Spectrum Disorder and Circadian Rhythm Sleep Disorders and is currently completed. Vanda Pharmaceuticals leads this study, which shows 9 recorded versions since 2016 — indicating limited longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.

Status Flow

Change History

9 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Apr 2024 — Jul 2024 [monthly]

Completed PHASE1

Status: Unknown Status → Completed
Jan 2021 — Apr 2024 [monthly]

Unknown Status PHASE1
Feb 2019 — Jan 2021 [monthly]

Unknown Status PHASE1

Status: Recruiting → Unknown Status

▶ Show 4 earlier versions

Jun 2018 — Feb 2019 [monthly]

Recruiting PHASE1
Mar 2017 — Jun 2018 [monthly]

Recruiting PHASE1
Feb 2017 — Mar 2017 [monthly]

Recruiting PHASE1
Jan 2017 — Feb 2017 [monthly]

Recruiting PHASE1

First recorded

Oct 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Vanda Pharmaceuticals

Data source: Vanda Pharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Baltimore, United States