NCT04652882

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
1mo left

Started Dec 2020

Longer than P75 for phase_3

Geographic Reach
3 countries

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Dec 2020Jun 2026

First Submitted

Initial submission to the registry

November 19, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

December 9, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

5.5 years

First QC Date

November 19, 2020

Last Update Submit

November 24, 2025

Conditions

Sleep Wake DisordersSleep Disorders, Circadian RhythmChronobiology Disorders

Outcome Measures

Primary Outcomes (1)

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

    28 days

Secondary Outcomes (3)

  • Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy.

    28 days

  • 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

Study Arms (2)

Tasimelteon

EXPERIMENTAL
Drug: Tasimelteon

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TasimelteonDRUG

oral capsule

Tasimelteon
PlaceboDRUG

oral capsule

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Vanda Investigational Site

Los Angeles, California, 90025, United States

RECRUITING

Vanda Investigational Site

Redwood City, California, 94063, United States

RECRUITING

Vanda Investigational Site

Aurora, Colorado, 80045, United States

RECRUITING

Vanda Investigational Site

Boston, Massachusetts, 02115, United States

RECRUITING

Vanda Investigational Site

St Louis, Missouri, 63123, United States

RECRUITING

Vanda Investigational Site

New Hyde Park, New York, 11042, United States

RECRUITING

Vanda Investigational Site

Cincinnati, Ohio, 45212, United States

RECRUITING

Vanda Investigational Site

Cleveland, Ohio, 44195, United States

RECRUITING

Vanda Investigational Site

Columbia, South Carolina, 29201, United States

RECRUITING

Vanda Investigational Site

San Antonio, Texas, 78229, United States

RECRUITING

Vanda Investigational Site

Sherman, Texas, 75092, United States

RECRUITING

Vanda Investigational Site

Innsbruck, 6020, Austria

ACTIVE NOT RECRUITING

Vanda Investigational Site

Vienna, 1090, Austria

RECRUITING

Vanda Investigational Site

Berlin, 10117, Germany

RECRUITING

Vanda Investigational Site

Hamburg, 20253, Germany

RECRUITING

Vanda Investigational Site

Marburg, 35043, Germany

RECRUITING

Vanda Investigational Site

Schwerin, 19053, Germany

RECRUITING

Related Publications (1)

  • Smieszek SP, Kaden AR, Johnson CE, Brzezynski JL, Xiao C, Polymeropoulos CM, Birznieks G, Emsellem HA, Polymeropoulos MH. Case report: A patient with Delayed Sleep-Wake Phase Disorder and Optic Nerve Hypoplasia treated with tasimelteon: a case study. Front Neurosci. 2023 Nov 14;17:1287514. doi: 10.3389/fnins.2023.1287514. eCollection 2023.

    PMID: 38033548DERIVED

MeSH Terms

Conditions

Sleep Wake DisordersSleep Disorders, Circadian RhythmChronobiology Disorders

Interventions

tasimelteon

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersDyssomniasOccupational Diseases

Central Study Contacts

Vanda Pharmaceuticals Inc.

CONTACT

202-734-3400clinicaltrials@vandapharma.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2020

First Posted

December 3, 2020

Study Start

December 9, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(11)AU(2)DE(4)