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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: Recruiting Phase 3 study of Sleep Wake Disorders and Sleep Disorders, Circadian Rhythm, sponsored by Vanda Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2020-12-09 |
| Est. Completion | 2026-06 |
| Phase | Phase 3 |
What NCT04652882 shows while recruiting
NCT04652882 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 93-participant average among 6 other Sleep Wake Disorders trials with a reported enrollment target (25% lower).
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 lists 17 locations in 9 states (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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