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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). 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.
Primary Outcome
Sleep latency is the time from laying down until falling asleep. Actigraphy data obtained using Axivity- AX6.
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 |
What the finished NCT05463861 record still lists
NCT05463861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05463861 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05463861's enrollment target sits among peer trials
71 1040th of 2000 higher than 958 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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