Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
← catalyst calendarNCT06953869 · readout ≤ 468 d
Sponsored by Vanda Pharmaceuticals (industry) · VNDA — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
420estimated
Sites
35
Countries
Germany, Poland, United Kingdom +1
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 | 2025-04-21 | actual | When the study began enrolling |
| Primary completion | Nov 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-05-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Insomnia Disorder
Interventions
- Drug: Tasimelteon Oral Suspension
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFChange in sleep latency, as measured by daily sleep diary.
measured 12 Weeks
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