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

Description

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.

Conditions

Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Sleep Wake Disorders
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Vanda Investigational Site, Los Angeles, California, United States, 90025

Redwood City

Vanda Investigational Site, Redwood City, California, United States, 94063

Aurora

Vanda Investigational Site, Aurora, Colorado, United States, 80045

Miami

Vanda Investigational Site, Miami, Florida, United States, 33176

Boston

Vanda Investigational Site, Boston, Massachusetts, United States, 02115

Rochester

Vanda Investigational Site, Rochester, Minnesota, United States, 55905

St. Louis

Vanda Investigational Site, St. Louis, Missouri, United States, 63123

New Hyde Park

Vanda Investigational Site, New Hyde Park, New York, United States, 11042

Cincinnati

Vanda Investigational Site, Cincinnati, Ohio, United States, 45212

Cleveland

Vanda Investigational Site, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanda Pharmaceuticals,

Study Record Dates

2025-12