Actively Recruiting
Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
Led by Vanda Pharmaceuticals · Updated on 2025-12-02
70
Participants Needed
17
Research Sites
285 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 60 18 and 64 35 kg/m^2.
You will not qualify if you...
- Exacerbation of an existing psychiatric condition requiring treatment change within 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 breastfeeding.
- Positive test for substances of abuse.
- Current tobacco user.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Vanda Investigational Site
Los Angeles, California, United States, 90025
Actively Recruiting
2
Vanda Investigational Site
Redwood City, California, United States, 94063
Actively Recruiting
3
Vanda Investigational Site
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Vanda Investigational Site
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
Vanda Investigational Site
St Louis, Missouri, United States, 63123
Actively Recruiting
6
Vanda Investigational Site
New Hyde Park, New York, United States, 11042
Actively Recruiting
7
Vanda Investigational Site
Cincinnati, Ohio, United States, 45212
Actively Recruiting
8
Vanda Investigational Site
Cleveland, Ohio, United States, 44195
Actively Recruiting
9
Vanda Investigational Site
Columbia, South Carolina, United States, 29201
Actively Recruiting
10
Vanda Investigational Site
San Antonio, Texas, United States, 78229
Actively Recruiting
11
Vanda Investigational Site
Sherman, Texas, United States, 75092
Actively Recruiting
12
Vanda Investigational Site
Innsbruck, Austria, 6020
Active, Not Recruiting
13
Vanda Investigational Site
Vienna, Austria, 1090
Actively Recruiting
14
Vanda Investigational Site
Berlin, Germany, 10117
Actively Recruiting
15
Vanda Investigational Site
Hamburg, Germany, 20253
Actively Recruiting
16
Vanda Investigational Site
Marburg, Germany, 35043
Actively Recruiting
17
Vanda Investigational Site
Schwerin, Germany, 19053
Actively Recruiting
Research Team
V
Vanda Pharmaceuticals Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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