Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
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.
|Condition or Disease||Intervention/Treatment||Phase|
Arms and Interventions
|Placebo Comparator: Placebo
Primary Outcome Measures
- Change in Sleep Onset over the treatment period, as measured by sleep diary. [28 days]
Secondary Outcome Measures
- Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy. [28 days]
- Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary. [28 days]
- Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs). [28 days]
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.
History of psychiatric disorders within 12 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.
Contacts and Locations
|1||Vanda Investigational Site||Los Angeles||California||United States||90025|
|2||Vanda Investigational Site||Redwood City||California||United States||94063|
|3||Vanda Investigational Site||Miami||Florida||United States||33176|
|4||Vanda Investigational Site||Atlanta||Georgia||United States||30328|
|5||Vanda Investigational Site||Chicago||Illinois||United States||60611|
|6||Vanda Investigational Site||Chevy Chase||Maryland||United States||20815|
|7||Vanda Investigational Site||Boston||Massachusetts||United States||02115|
|8||Vanda Investigational Site||Rochester||Minnesota||United States||55905|
|9||Vanda Investigational Site||Durham||North Carolina||United States||27705|
|10||Vanda Investigational Site||Cincinnati||Ohio||United States||45212|
|11||Vanda Investigational Site||Cleveland||Ohio||United States||44195|
|12||Vanda Investigational Site||Danville||Pennsylvania||United States||17822|
|13||Vanda Investigational Site||Malvern||Pennsylvania||United States||19355|
|14||Vanda Investigational Site||Columbia||South Carolina||United States||29201|
|15||Vanda Investigational Site||Austin||Texas||United States||78731|
Sponsors and Collaborators
- Vanda Pharmaceuticals
Study Documents (Full-Text)None provided.