Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
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Phase
Phase 3
Status
Unknown status
Study type
Interventional
Design
Na · None · Treatment
Enrollment
100estimated
Sites
5
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-07-28 | actual | When the study began enrolling |
| Primary completion | Jul 2025 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2025 | estimated | The whole study's end, after follow-up |
| First posted | 2022-05-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2024-03-21 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Autism Spectrum Disorder
- Sleep Disorder
- Neurological Disorder
- Sleep Disturbance
Intervention
- Drug: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
Primary outcome
what the primary-completion date above is the date OFChange in sleep time over the treatment period, as measured by sleep diary.
measured 12 weeks
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