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

Last updated: November 14, 2024
Sponsor: Vanda Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Narcolepsy

Treatment

Placebo

Tasimelteon

Clinical Study ID

NCT04652882
VP-VEC-162-3502
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

  • Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more dayswithin 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.

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 09, 2020
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Vanda Investigational Site

    Glebe, New South Wales 2037
    Australia

    Site Not Available

  • Vanda Investigational Site

    Innsbruck, 6020
    Austria

    Site Not Available

  • Vanda Investigational Site

    Linz, 4020
    Austria

    Active - Recruiting

  • Vanda Investigational Site

    Vienna, 1090
    Austria

    Active - Recruiting

  • Vanda Investigational Site

    Berlin, 10117
    Germany

    Active - Recruiting

  • Vanda Investigational Site

    Hamburg, 20253
    Germany

    Active - Recruiting

  • Vanda Investigational Site

    Marburg, 35043
    Germany

    Active - Recruiting

  • Vanda Investigational Site

    Munich, 81377
    Germany

    Active - Recruiting

  • Vanda Investigational Site

    München, 81377
    Germany

    Site Not Available

  • Vanda Investigational Site

    Schwerin, 19053
    Germany

    Active - Recruiting

  • Vanda Investigational Site

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Vanda Investigational Site

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Redwood City, California 94063
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Santa Monica, California 90404
    United States

    Site Not Available

  • Vanda Investigational Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Vanda Investigational Site

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Vanda Investigational Site

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Vanda Investigational Site

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Saint Louis, Missouri 63123
    United States

    Site Not Available

  • Vanda Investigational Site

    St. Louis, Missouri 63123
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Lake Success, New York 11042
    United States

    Site Not Available

  • Vanda Investigational Site

    New Hyde Park, New York 11042
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Vanda Investigational Site

    Cincinnati, Ohio 45212
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Portland, Oregon 97214
    United States

    Site Not Available

  • Vanda Investigational Site

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Vanda Investigational Site

    Malvern, Pennsylvania 19355
    United States

    Site Not Available

  • Vanda Investigational Site

    Columbia, South Carolina 29201
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Austin, Texas 78731
    United States

    Site Not Available

  • Vanda Investigational Site

    McKinney, Texas 75071
    United States

    Active - Recruiting

  • Vanda Investigational Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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