Study Comparing Tasimelteon and Placebo in Adults with Delayed Sleep-Wake Phase Disorder and the CRY1-11 Variant A Double-Blind, Randomized, Two-Period Crossover Phase 3 Trial

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.

Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant