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

Vanda Pharmaceuticals1 site in 1 country70 target enrollmentDecember 9, 2020

ConditionsSleep Wake Disorders Sleep Disorders, Circadian Rhythm Chronobiology Disorders

InterventionsTasimelteon Placebo

DrugsTasimelteon Placebo

Overview

Phase: Phase 3
Intervention: Tasimelteon
Conditions: Sleep Wake Disorders
Sponsor: Vanda Pharmaceuticals
Enrollment: 70
Locations: 1
Primary Endpoint: Change in Sleep Onset over the treatment period, as measured by sleep diary.
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female participants with DSWPD.

Registry

clinicaltrials.gov

Start Date

December 9, 2020

End Date

June 1, 2026

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

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).
•Men or women between 18 - 75 years, inclusive.
•Body Mass Index (BMI) of ≥ 18 and ≤ 35 kg/m\^2.

Exclusion Criteria

•Exacerbation of an existing psychiatric condition that requires change in treatment or intervention in the past 3 months.
•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.

Arms & Interventions

Tasimelteon

Intervention: Tasimelteon

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change in Sleep Onset over the treatment period, as measured by sleep diary.

Time Frame: 28 days

Secondary Outcomes

Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary.(28 days)
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).(28 days)
Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy.(28 days)