Condition: Sleep Wake Disorders · Sleep Disorders, Circadian Rhythm · Chronobiology Disorders · Sponsor: Vanda Pharmaceuticals
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.
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.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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.
| 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 | — |
+ 5 more locations — full list on the registry record.
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