Lemborexant in Delayed Sleep Phase Syndrome

NCT06874855 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 23-38738
• Study Type: interventional
• Target: 15
• 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, the investigators 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

Keywords

Delayed Sleep Phase Syndrome; Syndrome; Lemborexant

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)

Placebo

PLACEBO COMPARATOR

Patients receive placebo to match Lemborexant for 14 days

Drug: Placebo

Lemborexant

ACTIVE COMPARATOR

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

Drug: Lemborexant

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: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Participants will be required to be 18 years of age or older and have delayed sleep phase syndrome (DSPS). Questionnaires will be used to identify potential confounders and to confirm a potential diagnosis of DSPS based on ICSD3 criteria: a) Sleep is delayed by two hours or more beyond what is considered an acceptable or conventional bedtime for the subject (their desired bedtime). b) Subjects not able to fall asleep if trying to sleep before the later bedtime; c) This is interfering with their wishes/having a 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, or any medical disorder/therapy that could interfere with the trial
• 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.
• 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, 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Eisai Co., Ltd.: collaborator
• Stanford University: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94107, United States

RECRUITING

Related Publications (5)

• Duffy JF, Dijk DJ, Hall EF, Czeisler CA. Relationship of endogenous circadian melatonin and temperature rhythms to self-reported preference for morning or evening activity in young and older people. J Investig Med. 1999 Mar;47(3):141-50.

  PMID: 10198570 BACKGROUND

• Micic G, Richardson C, Cain N, Reynolds C, Bartel K, Maddock B, Gradisar M. Readiness to change and commitment as predictors of therapy compliance in adolescents with Delayed Sleep-Wake Phase Disorder. Sleep Med. 2019 Mar;55:48-55. doi: 10.1016/j.sleep.2018.12.002. Epub 2018 Dec 14.

  PMID: 30763869 BACKGROUND

• Zeitzer JM, Joyce DS, McBean A, Quevedo YL, Hernandez B, Holty JE. Effect of Suvorexant vs Placebo on Total Daytime Sleep Hours in Shift Workers: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e206614. doi: 10.1001/jamanetworkopen.2020.6614.

  PMID: 32484552 BACKGROUND

• Zeitzer JM, Buckmaster CL, Lyons DM, Mignot E. Increasing length of wakefulness and modulation of hypocretin-1 in the wake-consolidated squirrel monkey. Am J Physiol Regul Integr Comp Physiol. 2007 Oct;293(4):R1736-42. doi: 10.1152/ajpregu.00460.2007. Epub 2007 Aug 8.

  PMID: 17686881 BACKGROUND

• Zhang S, Zeitzer JM, Yoshida Y, Wisor JP, Nishino S, Edgar DM, Mignot E. Lesions of the suprachiasmatic nucleus eliminate the daily rhythm of hypocretin-1 release. Sleep. 2004 Jun 15;27(4):619-27. doi: 10.1093/sleep/27.4.619.

  PMID: 15282996 BACKGROUND

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Syndrome

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew D Krystal, MD, MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew D Krystal, MD, MS

CONTACT

415-476-7702; andrew.krystal@ucsf.edu

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: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: March 13, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD from enrolled participants will be available to collaborators for the duration of the study (Mar 2023 - May 2027 (anticipated) until the study has ended.
• Access Criteria: Collaborator Emmanuel Mignot from Stanford University and study sponsor Eisai will be able to access the data as participants from UCSF and Stanford will be combined for the overall data analyses

Locations

US (1)