The Effects of Lemborexant on the Ability to Sleep During Daytime

NCT06231641 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: DVG-IIS-M001-1008
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study aim to evaluate whether a dose of 5 mg of lemborexant, as compared to a placebo, may improve daytime recovery sleep, without producing lingering sleepiness during wakefulness, using a 3-day simulated night shift protocol in the lab under constant monitoring.

Conditions

Shift-Work Sleep Disorder

Keywords

Daytime sleep episodes; Polysomnographic recordings; Subjective sleep evaluations; Total sleep time (TST); Wake after sleep onset (WASO)

Outcome Measures

Primary Outcomes (2)

• Total sleep duration (objective measure)

  Assess the efficacy of lemborexant compared to placebo on PSG measured total sleep time (TST) during daytime recovery sleep using the mean data of the second and third daytime sleep episodes in each condition.

  during the intervention

• Wake after sleep onset (objective measure)

  Assess the efficacy of lemborexant compared to placebo on polysomnographically (PSG) measured wake after sleep onset (WASO) during daytime recovery sleep using the mean data of the second and third daytime sleep episodes in each condition

  during the intervention

Secondary Outcomes (2)

• Total sleep duration (subjective measure)

  during the intervention

• Wake after sleep onset (subjective measure)

  during the intervention

Study Arms (2)

Active treatment condition

ACTIVE COMPARATOR

Lemborexant at a 5mg dose is delivered in a film-coated tablet

Drug: Lemborexant 5 MG [Dayvigo]

Placebo condition

PLACEBO COMPARATOR

Placebo is delivered in a film-coated tablet

Other: Matching Placebo

Interventions

Lemborexant 5 MG [Dayvigo] DRUG

Lemborexant 5 mg will be taken orally once per day just prior to initiating laboratory-supervised daytime sleep episodes, for three consecutive days, within a few minutes before going to bed, with at least seven hours remaining before the planned time of awakening.

Active treatment condition

Matching Placebo OTHER

Matching placebo will be taken orally once per day just prior to initiating laboratory-supervised daytime sleep episodes, for three consecutive days, within a few minutes before going to bed, with at least seven hours remaining before the planned time of awakening.

Placebo condition

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged between 20 and 65 years, inclusive
• Be willing and able to give informed consent for study participation
• Participants must not have done shiftwork in the past year
• Normal vital signs values are: oral body temperature between 36.1 and 37.5 ºC (95 and 99.5 °F), supine SBP between 90 and 140 mmHg inclusive; supine DBP between 55 and 90 mmHg inclusive; heart rate between 50 and 100 bpm inclusive.
• Be willing to comply with all study requirements and procedures for the duration of the study, including refraining from consuming alcohol 48 hours prior to each experimental visit and grapefruit products (juice or fruit itself), Seville orange, lime, pomelo, carambola and pomegranate during all the duration of the study (from Visit 1 to Visit 4).
• Women who:
• Are postmenopausal, with amenorrhea for at least 1 year before the screening visit, OR
• Are surgically sterile, OR
• If of childbearing potential agree to practice effective double barrier methods of contraception, from the time of the signing of informed consent through the last dose of study drug and for 30 days after dosing stops (1 ovulatory cycle), or agree to completely abstain from intercourse.
• Men with women partners of childbearing potential are also expected to practice effective barrier methods of contraception from the time of signing informed consent through the last dose of study drug and for 30 days after dosing stops.
• Self-reported bedtime was between 9 pm and midnight on 4-7 nights per week.

You may not qualify if:

• Body mass index \> 32 as calculated from the participant's height (m) and weight (kg); weight (kg)/square height (m²)
• History of epilepsy
• Any previous serious head injury or stroke
• Any evidence of psychiatric disorder (including Beck Depression Inventory \[BDI\] ≥ 20 at screening, or a score of 3 on item related to suicidal ideas)
• Evidence of any clinically significant, or unstable, acute or chronically progressive medical or surgical disorder (including planned medical procedures that may impact sleep), or any condition that may interfere with the absorption, metabolism, distribution, or excretion of the study drug, or may affect the participant's safety
• Clinically significant and abnormal electrocardiogram (ECG; including QTc ≥ 450 ms for males, 460 ms for females) or a history of cardiovascular disease including poorly controlled hypertension, ischemic heart disease, arrhythmia, or severe heart failure
• Severe hepatic impairment
• Positive qualitative urine drug screen (opiates, cocaine, amphetamine, cannabinoids, barbiturates, phencyclidine, benzodiazepines, methadone, propoxyphene) and alcohol test (breathalyzer), at screening and before each experimental visit
• Current use of medications that are moderate or strong CYP3A4 inhibitors or inducers or CYP2B6 substrates (Appendix 1)
• Use of any substance with psychotropic effects or properties known to affect sleep/wake, including hypnotics, neuroleptics, opioid derivatives, antihistamines, stimulants, antidepressants, within one week or five half-lives (whichever is longer) prior to PSG screening
• Use of any over-the-counter sleep medications including tryptophan, valerian root (Valeriana officinalis), kava (Piper methysticum Forst), melatonin, St John's Wort (Hypericum perforatum), Alluna (herbal sleep supplement with valerian root), and hemp within one week or five half-lives (whichever is longer) prior to screening
• Consumption of xanthine-containing beverages (i.e., tea, coffee, or cola) of more than 5 cups or glasses per day
• Participation in any other trial within 30 days before the screening visit
• Any travel across more than one time zone in the month prior to screening at any time during the study
• Women who are pregnant, during the study or within one month after the study, or are breastfeeding

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead

Study Sites (1)

CIUSSS du Nord de l'ile de Montreal (CIUSSS-NIM) - Hôpital du Sacré-Cœur de Montréal (HSCM)

Montreal, Quebec, H4J 1C5, Canada

RECRUITING

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

Central Study Contacts

Alex Desautels, M.D., Ph.D.

CONTACT

514-338-2692; alex.desautels@umontreal.ca

Veronique Daneault, M.Sc, Ph.D.

CONTACT

438-224-2474; veronique.daneault.cnmtl@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised, double-blind, placebo-controlled crossover mono-centric feasibility study

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 30, 2024
• Study Start: January 11, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)