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Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
Sponsor: Vanda Pharmaceuticals
Summary
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.
Official title: A Double-Blind, Randomized, Two-Period Crossover Study to Evaluate the Effects of Tasimelteon Vs. Placebo in Subjects with Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-10-08
Completion Date
2025-06-30
Last Updated
2024-11-22
Healthy Volunteers
No
Conditions
Interventions
Tasimelteon
Oral capsule
Placebo
Oral capsule
Locations (1)
Vanda Investigational Site
Çankaya, Ankara, Turkey (Türkiye)