NCT04652882

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

A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Participants With Delayed Sleep-Wake Phase Disorder (DSWPD)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Wake Disorders
• Sleep Disorders, Circadian Rhythm
• Chronobiology Disorders

Interventions

Type	Name	Description
DRUG	Tasimelteon	oral capsule
DRUG	Placebo	oral capsule

Timeline

• Start date: 2020-12-09
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2020-12-03
• Last updated: 2025-12-02

Locations

17 sites across 3 countries: United States, Austria, Germany

Regulatory

• FDA-regulated drug study