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Study identifier: NCT04652882 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Active Not Recruiting

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

Condition: Sleep Wake Disorders · Sleep Disorders, Circadian Rhythm · Chronobiology Disorders  ·  Sponsor: Vanda Pharmaceuticals

PhasePhase 3
Planned participants70
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where17 locations · 3 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (17)

Vanda Investigational SiteLos Angeles, California, United States
Vanda Investigational SiteRedwood City, California, United States
Vanda Investigational SiteAurora, Colorado, United States
Vanda Investigational SiteBoston, Massachusetts, United States
Vanda Investigational SiteSt Louis, Missouri, United States
Vanda Investigational SiteNew Hyde Park, New York, United States
Vanda Investigational SiteCincinnati, Ohio, United States
Vanda Investigational SiteCleveland, Ohio, United States
Vanda Investigational SiteColumbia, South Carolina, United States
Vanda Investigational SiteSan Antonio, Texas, United States
Vanda Investigational SiteSherman, Texas, United States
Vanda Investigational SiteInnsbruck, Austria

+ 5 more locations — full list on the registry record.

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