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NCT Number: NCT04652882

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Sleep Wake Disorders Chronobiology Disorders Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Occupational Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Circadian Rhythm

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanda Investigational Site, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

tasimelteon

Drug

oral capsule

Placebo

Drug

oral capsule

Primary outcomes

  1. Change in Sleep Onset over the treatment period, as measured by sleep diary.

    Time frame: 28 days

Secondary outcomes

  1. Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy.

    Time frame: 28 days

  2. Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary.

    Time frame: 28 days

  3. Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2020
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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