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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
oral capsule
oral capsule
Vanda Investigational Site
Los Angeles, California, United States
RECRUITINGVanda Investigational Site
Change in Sleep Onset over the treatment period, as measured by sleep diary.
Time frame: 28 days
Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy.
Time frame: 28 days
Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary.
Time frame: 28 days
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).
Time frame: 28 days
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Redwood City, California, United States
Vanda Investigational Site
Aurora, Colorado, United States
RECRUITINGVanda Investigational Site
Boston, Massachusetts, United States
RECRUITINGVanda Investigational Site
St Louis, Missouri, United States
RECRUITINGVanda Investigational Site
New Hyde Park, New York, United States
RECRUITINGVanda Investigational Site
Cincinnati, Ohio, United States
RECRUITINGVanda Investigational Site
Cleveland, Ohio, United States
RECRUITINGVanda Investigational Site
Columbia, South Carolina, United States
RECRUITINGVanda Investigational Site
San Antonio, Texas, United States
RECRUITING...and 7 more locations