Trials / Completed
CompletedNCT02776215
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Vanda Pharmaceuticals · Industry
- Sex
- All
- Age
- 3 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents.
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.
Conditions
- Circadian Rhythm Sleep Disorders
- Non-24 Hour Sleep-Wake Disorder
- Autism Spectrum Disorder
- Smith-Magenis Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tasimelteon | Melatonin receptor agonist |
Timeline
- Start date
- 2016-10-04
- Primary completion
- 2017-12-20
- Completion
- 2017-12-20
- First posted
- 2016-05-18
- Last updated
- 2024-03-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02776215. Inclusion in this directory is not an endorsement.