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

Phase 3 Recruiting 60 enrolled Vanda Pharmaceuticals

RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start: 2024-10-08
Primary completion: 2025-06-30
Completion: 2025-06-30

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	tasimelteon	Small molecule	—	Oral

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

Summary

Timeline

Drugs

Indications