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Tasimelteon PK and Safety in Children and Adolescents
NCT02776215Phase 1Completed
- Sponsor
- Vanda Pharmaceuticals Inc.
- Start
- Oct 2016
- Primary completion
- Dec 2017
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, open-label, single-arm trial of tasimelteon in Non-24-hour sleep-wake disorder (N24SWD), Smith-Magenis syndrome (SMS) and Autism Spectrum Disorder (ASD), sponsored by Vanda Pharmaceuticals Inc. Primary endpoints: Area under the curve of tasimelteon and its metabolites, Maximum concentration of tasimelteon and its metabolites and 5 more. Started Oct 2016; status: completed.
02
Drugs
tasimelteon
03
Conditions
Non-24-hour sleep-wake disorder (N24SWD)Smith-Magenis syndrome (SMS)Autism Spectrum Disorder (ASD)
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