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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders

In brief

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.

Key facts

Study ID

NCT04652882

Run by

Vanda Pharmaceuticals

People needed

70

Starts

2020-12-09

Expected to finish

2026-09-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability and acceptance to provide written informed consent.
• A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).
• Men or women between 18 - 75 years, inclusive.
• Body Mass Index (BMI) of ≥ 18 and ≤ 35 kg/m\^2.

You may not qualify if…

• Exacerbation of an existing psychiatric condition that requires change in treatment or intervention in the past 3 months.
• Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days.
• Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.
• A positive test for substances of abuse.
• Current tobacco user.

Where it is running

• Vanda Investigational Site — Los Angeles, California, United States
• Vanda Investigational Site — Redwood City, California, United States
• Vanda Investigational Site — Aurora, Colorado, United States
• Vanda Investigational Site — Boston, Massachusetts, United States
• Vanda Investigational Site — St Louis, Missouri, United States
• Vanda Investigational Site — New Hyde Park, New York, United States
• Vanda Investigational Site — Cincinnati, Ohio, United States
• Vanda Investigational Site — Cleveland, Ohio, United States
• Vanda Investigational Site — Columbia, South Carolina, United States
• Vanda Investigational Site — San Antonio, Texas, United States
• Vanda Investigational Site — Sherman, Texas, United States
• Vanda Investigational Site — Innsbruck, Austria
• Vanda Investigational Site — Vienna, Austria
• Vanda Investigational Site — Berlin, Germany
• Vanda Investigational Site — Hamburg, Germany
• Vanda Investigational Site — Marburg, Germany
• Vanda Investigational Site — Schwerin, Germany

Full record on ClinicalTrials.gov

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