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Could a new pill fix your body clock? phase 3 trial underway

NCT ID NCT04652882

Ongoing Symptom relief Sponsor: Vanda Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether the drug tasimelteon can help people with Delayed Sleep-Wake Phase Disorder (DSWPD) fall asleep earlier and sleep better. 70 adults with DSWPD will receive either tasimelteon or a placebo daily. The study measures sleep onset and quality using sleep diaries and activity monitors.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
tasimelteon
What this could lead to
If it works, this could provide a new treatment option to help people with DSWPD fall asleep earlier and improve their sleep quality.
What could go wrong
This is a Phase 3 trial, but it's small (70 participants) and results may not apply to everyone. The drug may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Chronobiology Disorders circadian rhythm sleep disorder circadian rhythm sleep disorder, delayed sleep phase type sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CHRONOBIOLOGY DISORDERS SLEEP DISORDERS, CIRCADIAN RHYTHM SLEEP WAKE DISORDERS

Contacts and locations

Locations

  • Vanda Investigational Site

    Los Angeles, California, 90025, United States

  • Vanda Investigational Site

    Redwood City, California, 94063, United States

  • Vanda Investigational Site

    Aurora, Colorado, 80045, United States

  • Vanda Investigational Site

    Boston, Massachusetts, 02115, United States

  • Vanda Investigational Site

    St Louis, Missouri, 63123, United States

  • Vanda Investigational Site

    New Hyde Park, New York, 11042, United States

  • Vanda Investigational Site

    Cincinnati, Ohio, 45212, United States

  • Vanda Investigational Site

    Cleveland, Ohio, 44195, United States

  • Vanda Investigational Site

    Columbia, South Carolina, 29201, United States

  • Vanda Investigational Site

    San Antonio, Texas, 78229, United States

  • Vanda Investigational Site

    Sherman, Texas, 75092, United States

  • Vanda Investigational Site

    Innsbruck, 6020, Austria

  • Vanda Investigational Site

    Vienna, 1090, Austria

  • Vanda Investigational Site

    Berlin, 10117, Germany

  • Vanda Investigational Site

    Hamburg, 20253, Germany

  • Vanda Investigational Site

    Marburg, 35043, Germany

  • Vanda Investigational Site

    Schwerin, 19053, Germany

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