Actively Recruiting
A Double-Blind, Randomized, Two-Period Crossover Study to Evaluate Tasimelteon Versus Placebo in Adults with Delayed Sleep-Wake Phase Disorder and the CRY19411 Variant
Led by Vanda Pharmaceuticals · Updated on 2024-11-22
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a drug called tasimelteon compared to a placebo in adults diagnosed with Delayed Sleep-Wake Phase Disorder (DSWPD) who carry the CRY19411 gene variant. This phase 3 clinical trial aims to study the safety and effectiveness of a single oral dose of tasimelteon in improving sleep patterns in this specific group. Participants will receive either tasimelteon or a matching placebo in a double-blind, randomized, two-period crossover design. Each participant will receive both treatments in separate periods, allowing comparison of their effects within the same individual. Both tasimelteon and placebo are given as oral capsules. During the study, participants will undergo sleep assessments to measure how quickly they fall into persistent sleep, using polysomnography over two nights. The study involves careful monitoring of safety and efficacy during these treatment periods. Participation includes all visits and assessments related to dosing and sleep evaluation, with the entire process designed to understand how tasimelteon may influence sleep timing in DSWPD patients with the CRY19411 variant.
CONDITIONS
Brief 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 the CRY19411 variant.
- Men or women between 18 and 75 years old.
- Body Mass Index (BMI) between 18 and 40 kg/m.
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 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Two treatment periods with a washout in between (duration not specified)
Participants receive oral capsules of Tasimelteon or placebo in a randomized crossover design.
2 treatment periods with polysomnography assessments over two nights each
Trial Site Locations
Total: 1 location
1
Vanda Investigational Site
Çankaya, Ankara, Turkey (Türkiye), 06800
Actively Recruiting
Research Team
V
Vanda Pharmaceuticals Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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