Clinical Trial

Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female participants with DSWPD.
Protocol Amendment History 3 changes
critical Enrollment closed, study ongoing 2026-07-28
notable Primary completion pushed: 2026-06 -> 2026-09 2026-07-28
minor Completion pushed: 2026-06 -> 2026-09 2026-07-28
Trial Details
NCT Number NCT04652882
Lead Sponsor Vanda Pharmaceuticals
Conditions Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders
Enrollment 70 participants
Start Date 2020-12-09
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-27