Clinical Trial

Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant

Recruiting Phase 3
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Record status
This record was last updated November 22, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.
Trial Details
NCT Number NCT06701396
Lead Sponsor Vanda Pharmaceuticals
Conditions Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders, Gene Mutations and Other Alterations Nec
Enrollment 60 participants
Start Date 2024-10-08
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-11-22