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

Active Not RecruitingPhase 3

Sponsor: Vanda Pharmaceuticals

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

Interventions: Tasimelteon, Placebo

Countries: United States, Austria, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (17)

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