A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Participants With Delayed Sleep-Wake Phase Disorder (DSWPD)
Vanda Pharmaceuticals
Summary
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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. *…
Interventions
- DrugTasimelteon
oral capsule
- DrugPlacebo
oral capsule
Locations (17)
- Vanda Investigational SiteLos Angeles, California
- Vanda Investigational SiteRedwood City, California
- Vanda Investigational SiteAurora, Colorado
- Vanda Investigational SiteBoston, Massachusetts
- Vanda Investigational SiteSt Louis, Missouri
- Vanda Investigational SiteNew Hyde Park, New York