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

Vanda Pharmaceuticals1 site in 1 country60 target enrollmentOctober 8, 2024

ConditionsSleep Wake Disorders Sleep Disorders, Circadian Rhythm Chronobiology Disorders Gene Mutations and Other Alterations Nec

InterventionsTasimelteon Placebo

DrugsTasimelteon Placebo

Overview

Phase: Phase 3
Intervention: Tasimelteon
Conditions: Sleep Wake Disorders
Sponsor: Vanda Pharmaceuticals
Enrollment: 60
Locations: 1
Primary Endpoint: Latency to Persistent Sleep, as measured by polysomnography.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 8, 2024

End Date

June 30, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Vanda Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ability and acceptance to provide written informed consent.
•A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).
•Carrier of CRY1Δ11 variant.
•Men or women between 18 - 75 years, inclusive.
•Body Mass Index (BMI) of ≥ 18 and ≤ 40 kg/m\^2.

Exclusion Criteria

•Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days.
•Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.
•A positive test for substances of abuse.
•Current tobacco user.