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

April 1, 2024 updated by: Vanda Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Glebe, New South Wales, Australia, 2037
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Hamburg, Germany, 20253
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • München, Germany, 81377
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Schwerin, Germany, 19053
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Redwood City, California, United States, 94063
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • Missouri
      • Saint Louis, Missouri, United States, 63123
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • McKinney, Texas, United States, 75071
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
oral capsule
Experimental: Tasimelteon
Drug: Tasimelteon
oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Sleep Onset over the treatment period, as measured by sleep diary.
Time Frame: 28 days
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

December 9, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 19, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VEC-162-3502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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