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NCT04652882 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Sleep Wake Disorders and Sleep Disorders, Circadian Rhythm, sponsored by Vanda Pharmaceuticals.

Recruiting
Registry status
Phase 3
Development phase
70
Enrollment target
17
Study locations

NCT04652882 is a Phase 3 study of Sleep Wake Disorders and Sleep Disorders, Circadian Rhythm that is actively recruiting participants, run by Vanda Pharmaceuticals. The registered enrollment target is 70 participants, below the 93-participant average among 6 other Sleep Wake Disorders trials with a reported enrollment target (25% lower). The trial reports 17 study locations across 9 states.

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The verdict

NCT04652882, a Phase 3 study of Sleep Wake Disorders and Sleep Disorders, Circadian Rhythm, is actively recruiting participants, sponsored by Vanda Pharmaceuticals.

RECRUITING
Registry status
Phase 3
Development phase
70 participants
Enrollment target
17
Study locations

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.

Conditions Studied

Sleep Wake Disorders Sleep Disorders, Circadian Rhythm Chronobiology Disorders

Interventions

  • DRUG Placebo
  • DRUG Tasimelteon

Study Locations (17)

Other

  • Vanda Investigational Site - Innsbruck
  • Vanda Investigational Site - Vienna
  • Vanda Investigational Site - Berlin
  • Vanda Investigational Site - Hamburg
  • Vanda Investigational Site - Marburg
  • Vanda Investigational Site - Schwerin

California

  • Vanda Investigational Site - Los Angeles
  • Vanda Investigational Site - Redwood City

Ohio

  • Vanda Investigational Site - Cincinnati
  • Vanda Investigational Site - Cleveland

Texas

  • Vanda Investigational Site - San Antonio
  • Vanda Investigational Site - Sherman

Colorado

  • Vanda Investigational Site - Aurora

Massachusetts

  • Vanda Investigational Site - Boston

Missouri

  • Vanda Investigational Site - St Louis

New York

  • Vanda Investigational Site - New Hyde Park

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2020-12-09
Est. Completion 2026-06
Phase Phase 3

Sponsor

Vanda Pharmaceuticals

68 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04652882

The ClinicalTrials.gov registry entry for NCT04652882 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 93-participant average among 6 other Sleep Wake Disorders trials with a reported enrollment target (25% lower). The listed sponsor is Vanda Pharmaceuticals, which has 68 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Sleep Wake Disorders appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04652882 reports 17 study locations spanning 9 distinct geographic areas - top geographies include Other, California, Ohio.

Frequently Asked Questions

What is clinical trial NCT04652882 about?

NCT04652882 is a clinical study titled "Evaluating the Effects of Tasimelteon vs. Placebo in 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.

What is the current status of trial NCT04652882?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2020-12-09. Estimated completion is 2026-06.

What conditions does trial NCT04652882 study?

This clinical trial studies the following conditions: Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders.

What interventions are being tested in trial NCT04652882?

The interventions under investigation include: Placebo (DRUG), Tasimelteon (DRUG).

Who is sponsoring clinical trial NCT04652882?

This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04652882 being conducted?

This trial has 17 study locations across California, Colorado, Massachusetts, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.