RecruitingPhase 3NCT04652882
Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Participants With Delayed Sleep-Wake Phase Disorder (DSWPD)
Sponsor
Vanda Pharmaceuticals
Enrollment
70 participants
Start Date
Dec 9, 2020
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria4
- 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 Criteria5
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGTasimelteon
oral capsule
DRUGPlacebo
oral capsule
Locations(17)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04652882
Related Trials
Effect of L. Reuteri LM1063 on Sleep Health Improvement
NCT074987121 location
Mind After Midnight
NCT074389121 location
Sleep Disorders in Hypothalamic and Pituitary Damage
NCT071432661 location
The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional)
NCT052471251 location
Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
NCT067788112 locations