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Lemborexant in Delayed Sleep Phase Syndrome

NCT05463861 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2026-03-02

No results posted yet for this 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.

Conditions

  • Delayed Sleep Phase Syndrome

Interventions

DRUG

Lemborexant

Lemborexant tablet administered orally once daily.

DRUG

Placebo

Placebo to match Lemborexant tablet administered orally once daily.

Sponsors & Collaborators

Principal Investigators

  • Emmanuel Mignot, MD, PhD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2026-01-21
Completion
2026-01-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05463861 on ClinicalTrials.gov