Actively Recruiting
Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
Led by Vanda Pharmaceuticals · Updated on 2024-11-22
60
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.
CONDITIONS
Official Title
Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability and acceptance to provide written informed consent.
- Confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).
- Carrier of CRY19411 variant.
- Men or women between 18 and 75 years, inclusive.
- Body Mass Index (BMI) of 65 18 and 64 40 kg/m2.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vanda Investigational Site
Çankaya, Ankara, Turkey (Türkiye), 06800
Actively Recruiting
Research Team
V
Vanda Pharmaceuticals Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here