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

Name: Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant — clinical trial record (NCT06701396)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

SponsorVanda Pharmaceuticals

Started2024-10-08

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Record status

This record was last updated November 22, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Vanda Pharmaceuticals

23 trials monitored

See 3 trials at risk

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.

Trial Details

NCT Number	NCT06701396
Lead Sponsor	Vanda Pharmaceuticals
Conditions	Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders, Gene Mutations and Other Alterations Nec
Enrollment	60 participants
Start Date	2024-10-08
Primary Completion	2025-06-30 (estimated)
Study Completion	2025-06-30 (estimated)
Updated on ClinicalTrials.gov	2024-11-22