A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Participants With Delayed Sleep-Wake Phase Disorder (DSWPD)

What this Trial Is About

Researchers are studying the effects of a drug called tasimelteon compared to a placebo in adults with Delayed Sleep-Wake Phase Disorder (DSWPD), a condition related to sleep timing problems. This is a phase 3, multicenter, double-blind, randomized trial designed to evaluate both the safety and effectiveness of tasimelteon in helping people with this disorder. Participants include men and women aged between 18 and 75 years with a confirmed diagnosis of DSWPD. Participants will receive either tasimelteon or a matching placebo in the form of an oral capsule taken once daily. The study uses a randomized assignment to one of these two groups and keeps participants and researchers unaware of which treatment is given to ensure unbiased results. The treatment period lasts 28 days during which sleep patterns and safety are carefully monitored. During the study, participants will keep sleep diaries to record their sleep onset and subjective sleep-wake patterns, while actigraphy devices will objectively track sleep times. Researchers will assess changes in sleep onset over 28 days as the primary outcome, along with other sleep parameters and safety based on reported adverse events. The trial includes close monitoring to ensure participant safety and adherence throughout the study period.

Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)