RECRUITING

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

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Conditions

Sleep Wake DisordersSleep Disorders, Circadian RhythmChronobiology Disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-12-09
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04652882

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability and acceptance to provide written informed consent.
  2. * A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).
  3. * Men or women between 18 - 75 years, inclusive.
  4. * Body Mass Index (BMI) of ≥ 18 and ≤ 35 kg/m\^2.
  1. * Exacerbation of an existing psychiatric condition that requires change in treatment or intervention in the past 3 months.
  2. * Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days.
  3. * Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.
  4. * A positive test for substances of abuse.
  5. * Current tobacco user.

Contacts and Locations

Study Contact

Vanda Pharmaceuticals Inc.
CONTACT
202-734-3400
VEC162@vandapharma.com

Study Locations (Sites)

Vanda Investigational Site
Los Angeles, California, 90025
United States
Vanda Investigational Site
Redwood City, California, 94063
United States
Vanda Investigational Site
Aurora, Colorado, 80045
United States
Vanda Investigational Site
Miami, Florida, 33176
United States
Vanda Investigational Site
Boston, Massachusetts, 02115
United States
Vanda Investigational Site
Rochester, Minnesota, 55905
United States
Vanda Investigational Site
St. Louis, Missouri, 63123
United States
Vanda Investigational Site
New Hyde Park, New York, 11042
United States
Vanda Investigational Site
Cincinnati, Ohio, 45212
United States
Vanda Investigational Site
Cleveland, Ohio, 44195
United States
Vanda Investigational Site
Columbia, South Carolina, 29201
United States
Vanda Investigational Site
McKinney, Texas, 75071
United States
Vanda Investigational Site
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Vanda Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-09
Study Completion Date2025-12

Study Record Updates

Study Start Date2020-12-09
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

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