Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
NCT ID: NCT04652882
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
70 participants
INTERVENTIONAL
2020-12-09
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tasimelteon
Tasimelteon
oral capsule
Placebo
Placebo
oral capsule
Interventions
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Tasimelteon
oral capsule
Placebo
oral capsule
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
References
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Smieszek SP, Kaden AR, Johnson CE, Brzezynski JL, Xiao C, Polymeropoulos CM, Birznieks G, Emsellem HA, Polymeropoulos MH. Case report: A patient with Delayed Sleep-Wake Phase Disorder and Optic Nerve Hypoplasia treated with tasimelteon: a case study. Front Neurosci. 2023 Nov 14;17:1287514. doi: 10.3389/fnins.2023.1287514. eCollection 2023.
Other Identifiers
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VP-VEC-162-3502
Identifier Type: -
Identifier Source: org_study_id
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