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NCT05463861 · ClinicalTrials.gov registry record · Phase 4
Lemborexant in Delayed Sleep Phase Syndrome
A Phase 4 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 4
- Development phase
- 71
- Enrollment target
NCT05463861: Completed Phase 4 study, sponsored by Stanford University.
NCT05463861 is a Phase 4 study that has completed, run by Stanford University. The registered enrollment target is 71 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05463861, a Phase 4 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 71 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate whether Lemborexant is more effective than placebo in shortening sleep onset latency in patients with delayed sleep phase syndrome (both type 1 and type 2). This will be tracked using sleep logs as well as actigraphy. In this 2-year study, we will examine if Lemborexant administered 5-10 mg nightly taken at desired bedtime (at least 2 hours prior to self-reported sleep onset habitual time) can improve the symptoms of Delayed Sleep Phase Syndrome.
Interventions
- DRUG Placebo
- DRUG Lemborexant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2022-02-01 |
| Est. Completion | 2026-01-21 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05463861
The ClinicalTrials.gov registry entry for NCT05463861 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05463861 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05463861 about?
NCT05463861 is a clinical study titled "Lemborexant in Delayed Sleep Phase Syndrome". The purpose of the study is to evaluate whether Lemborexant is more effective than placebo in shortening sleep onset latency in patients with delayed sleep phase syndrome (both type 1 and type 2). This will be tracked using sleep logs as well as actigraphy. In this 2-year study, we will examine if ...
What is the current status of trial NCT05463861?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 71 participants. The study started on 2022-02-01. Estimated completion is 2026-01-21.
What interventions are being tested in trial NCT05463861?
The interventions under investigation include: Placebo (DRUG), Lemborexant (DRUG).
Who is sponsoring clinical trial NCT05463861?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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