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NCT04652882
Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
Conditions: Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 70
Sponsor: Vanda Pharmaceuticals
Location: Vanda Investigational Site Los Angeles California
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 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.
Source: ClinicalTrials.gov (NCT04652882). StuddyBuddy aggregates publicly available trial information.
