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RECRUITING Phase 3

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

NCT04652882 · View on ClinicalTrials.gov ↗

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.

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

34 total trials

Interested in This Trial?

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanda Pharmaceuticals, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04652882 reports 17 study locations spanning 9 distinct geographic areas — top geographies include Other, California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04652882?

The interventions under investigation include: Placebo (DRUG), Tasimelteon (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04652882?

This trial is sponsored by Vanda Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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