Lemborexant in Delayed Sleep Phase Syndrome

NCT05463861 | Completed Phase 4 FDA Drug

• 1 other identifier: 59441
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in actigraphy sleep latency onset

  Sleep latency is the time from laying down until falling asleep. Actigraphy data obtained using Axivity- AX6.

  From 2 weeks prior to randomization to 4 weeks post randomization

Secondary Outcomes (8)

• Change in Epworth Sleepiness Scale (ESS)

  From randomization to 4 weeks post randomization

• Change in Karolinska Sleepiness Scale (KSS)

  From randomization to 4 weeks post randomization

• Change in sleep diary derived sleep onset latency

  From 2 weeks prior to randomization to 4 weeks post randomization

• Sleep Regularity Index

  From 2 weeks prior to randomization to 4 weeks post randomization

• Change in actigraphy derived total sleep time

  From 2 weeks prior to randomization to 4 weeks post randomization

Study Arms (2)

Lemborexant

ACTIVE COMPARATOR

Patients receive Lemborexant 5mg for 7 days and may be dose adjusted to 10mg. Patients continue to take Lemborexant 5mg or 10 mg for an additional 7 days.

Drug: Lemborexant

Placebo

PLACEBO COMPARATOR

Patients receive placebo to match Lemborexant for 14 days.

Drug: Placebo

Interventions

Lemborexant DRUG

Lemborexant tablet administered orally once daily.

Also known as: dayvigo®

Lemborexant

Placebo DRUG

Placebo to match Lemborexant tablet administered orally once daily.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• Diagnosed with delayed sleep phase syndrome (DSPS) meaning that:
• Sleep is delayed by two hours or more beyond what is considered an acceptable or conventional bedtime for the subject (their desired bedtime).
• Subjects not able to fall asleep if trying to sleep before the later bedtime;
• This is interfering with their wishes/having social impact.
• Concomitant medications will be allowed, though dosages will be required to remain fixed throughout participation in the study.
• The participant also needs to be willing and able to comply with all aspects of the protocol.

You may not qualify if:

• Clinically significant depression (PHQ-9 score of 10 or more), anxiety disorder (GAD-7 score of 10 or more), substance use disorder, any other sleep disorder (assessed by the Alliance Sleep Questionnaire- ASQ), or any medical disorder/therapy that could interfere with the trial (this will be verified through interview and analysis of the ASQ).
• Use of medications with significant effects on sleep-wake function (insomnia therapies, stimulants)- unless they are discontinued at least 5 half-lives prior to study participation. Non-sedative antidepressants or SSRI will be allowed if at a stable dose in the absence of concomitant severe depression or severe anxiety.
• Use of CYP3A inhibitors and CYP3A inducers, at least 1 week (or five half-lives, whichever is longer) prior to the first day of the baseline phase.
• Pregnancy (verified by urine pregnancy test on visits 1, 2, and 3) or plan to become pregnant in the next 3 months or currently breastfeeding.
• Shift workers or subjects working unusual hours.
• Any risk of suicide within 6 months of screening period or throughout the trial (accessed by the Investigator and by the C-SSRS questionnaire).
• Transmeridian travel across more than 3 time zones 4 weeks prior to the screening phase.
• Transmeridian travel across more than 2 time zones during this trial (including the screening phase).
• Having a positive drug test or being unwilling to refrain from using illegal drugs or marijuana during this trial.
• Any clinically abnormal symptom or organ impairment found by medical history at Screening or Baseline and physical examinations, vital signs, ECG findings, or laboratory test results that require medical treatment.
• Impaired liver function (values for enzymes aspartate transaminase (AST) and alanine transaminase (ALT) \> 1.5 times the Upper Limit of Normal).
• Known to be human immunodeficiency virus positive.
• Has a QT interval corrected using Fridericia's formula interval (QTcF interval) \>450 ms demonstrated on repeated ECGs (repeated only if initial ECG showed corrected QT interval (QTc) \>450 ms) at Screening or Baseline.

Sponsors & Collaborators

• University of California, San Francisco: collaborator
• Stanford University: lead

Study Sites (1)

Stanford Univeristy

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Study Officials

• Emmanuel Mignot, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: July 19, 2022
• Study Start: February 1, 2022
• Primary Completion: January 21, 2026
• Study Completion: January 21, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)