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Sleep Initiation and Maintenance DisordersPhase 2NCT05594589

A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder

A Phase 2 study testing Lemborexant and PBO in people with Sleep Initiation and Maintenance Disorders, run by Eisai Co., Ltd. at 9 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of the study is to evaluate the treatment difference between lemborexant 5 milligram (mg) (LEM5) and placebo (PBO) on latency to persistent sleep (LPS) using polysomnography (PSG) on Day 30. Read more about this study

Who is it for?
Ages 19 to 80 years
What is being tested?
Lemborexant and PBO
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
9 sitesSouth Korea
Study dates
30 Nov 2022to 24 May 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Korean male or female, age 19 to 80 years, at the time of informed consent
  • Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for Insomnia Disorder, as follows:
  • Complains of dissatisfaction with nighttime sleep, in the form of difficulty getting to sleep with or without difficulty staying asleep and/or awakening earlier in the morning than desired despite adequate opportunity for sleep
  • Frequency of complaint greater than or equal to (>=) 3 times per week
  • Duration of complaint >= 3 months
  • Associated with complaint of daytime impairment
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  • Subjective Sleep Onset Latency (sSOL) typically >= 30 minutes on at least 3 nights per week in the previous 4 weeks at Screening
  • Insomnia Severity Index (ISI) score >=13 at Screening
  • Regular time in bed between 6.5 and 9.0 hours at Screening
  • At 2nd Screening Visit (Visit 2): Confirmation (via Sleep Diary) of a regular bedtime, defined as the time the participant attempts to sleep, between 21:00 and 24:00 on at least 5 of the final 7 nights and regular waketime, defined as the time the participant gets out of bed for the day, between 05:00 and 09:00 on at least 5 of the final 7 nights.
  • Confirmation of current insomnia symptoms, as determined from responses on the sleep diary on the 7 most recent mornings before the PSG during Screening Period (Visit 2), such that sSOL >=30 minutes on at least 3 of the 7 nights
  • Confirmation of sufficient duration of time spent in bed, as determined from responses on the sleep diary on the 7 most recent mornings before the 2nd Screening Visit (Visit 2), such that there are no more than 2 nights with time spent in bed duration less than (<) 7 hours or greater than (>) 10 hours
  • During Run-in period, objective (PSG) evidence of insomnia as follows:
  • SE less than or equal to (<=) 85 percent (%); and
  • LPS >= 30 minutes
  • Provide written informed consent
  • Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night

Who cannot join

  • Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin (beta-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the 1st dose of study drug
  • Females of childbearing potential who:
  • Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
  • total abstinence (if it is their preferred and usual lifestyle)
  • an intrauterine device or intrauterine hormone-releasing system (IUS)
  • a contraceptive implant
Show all 42Show fewer
  • an oral contraceptive (Participant must have been on a stable dose of the same oral contraceptive product for at least 28 days before dosing and must agree to stay on the same dose of the oral contraceptive throughout the study and for 28 days after study drug discontinuation.)
  • have a vasectomized partner with confirmed azoospermia
  • Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation. It is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, that is, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing)
  • Any history of a medical or psychiatric condition that in the opinion of the investigator(s) could affect the participants safety or interfere with the study assessments
  • A prolonged QT interval corrected for heart rate by Fridericia's formula (QTcF) interval (QTcF >450 millisecond [ms]) as demonstrated by a repeated ECG. A history of risk factors for torsade de pointes (example, heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolonged the QTcF interval
  • Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening
  • Any lifetime suicidal behavior
  • Evidence of clinically significant disease (example, cardiac; respiratory including chronic obstructive pulmonary disease, acute and/or severe respiratory depression; gastrointestinal; moderate and severe hepatic impairment; renal including severe renal impairment; neurological including myasthenia gravis; psychiatric disease; or malignancy within the past 5 years other than adequately treated basal cell carcinoma) or chronic pain that in the opinion of the investigator(s) could affect the participants safety or interfere with the study assessments. Participants for whom a sedating drug would be contraindicated for safety reasons because of the participants occupation or activities
  • Hypersensitivity to lemborexant or to their excipients
  • Scheduled for surgery during the study that requires general anesthesia or administration of prohibited medications
  • Known to be human immunodeficiency virus (HIV) positive
  • Active viral hepatitis (B or C) as demonstrated by positive serology
  • History of drug or alcohol dependency or abuse within approximately the last 2 years
  • A current diagnosis of sleep-related breathing disorder including obstructive sleep apnea (with or without continuous positive airway pressure [CPAP] treatment), periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or narcolepsy, or an exclusionary score on screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia as follows:
  • STOPBang score >=5
  • International Restless Legs Scale (IRLS) >=16
  • Apnea-Hypopnea Index >15 or Periodic Limb Movement with Arousal Index >15 as measured on the PSG at the 2nd Screening Visit
  • Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicates the need for referral for a diagnostic evaluation for the presence of narcolepsy
  • Reports a history of sleep-related violent behavior, or sleep driving, or any other complex sleep-related behavior (example, making phone calls or preparing and eating food while sleeping)
  • For participants who underwent diagnostic PSG within 1 year before informed consent:
  • Age 19 to 64 years: Apnea hypopnea Index >=10, or Periodic Limb Movements with Arousal Index >=10,
  • Age >=65 years: Apnea Hypopnea Index >15, or Periodic Limb Movements with Arousal Index >15
  • Beck Depression Inventory-II (BDI-II) score >19 at Screening
  • Beck Anxiety Inventory (BAI) score >15 at Screening
  • Habitually naps during the day more than 3 times per week
  • Excessive caffeine use that in the opinion of the investigator contributes to the participants insomnia, or habitually consumes caffeine containing beverages after 18:00 and is unwilling to forego caffeine after 18:00 for the duration of his/her participation in the study. Participants are excluded if, in the previous 3 months, they had symptoms that would meet DSM-5 criteria for caffeine intoxication, which includes consumption of a high dose of caffeine (significantly in excess of 250 mg) and >=5 of the following symptoms: restlessness, nervousness, excitement, insomnia, flushed face, diuresis, gastrointestinal disturbance, muscle twitching, rambling flow of thought and speech, tachycardia or cardiac arrhythmia, periods of high energy, or psychomotor agitation. To be exclusionary, those symptoms must cause distress or impairment in social, occupational and other forms of functioning, and not be associated with other substance, mental disorder or medical condition
  • Reports habitually consuming more than 14 drinks containing alcohol per week (females) or more than 21 drinks containing alcohol per week (males), or unwilling to limit alcohol intake to no more than 2 drinks per day or forego having alcohol within the 3 hours before bedtime for the duration of his/her participation in the study
  • Comorbid nocturia that is causing or exacerbating the insomnia
  • Used any prohibited prescription or over-the-counter concomitant medications within 1 week or 5 half-lives, whichever is longer, before the 1st dose of study medication (Run-in Period)
  • Used any modality of treatment for insomnia, including cognitive behavioral therapy or marijuana within 1 week or 5 half-lives, whichever is longer, before the 1st dose of study medication (Run-in Period)
  • Failed treatment with dual orexin receptor antagonist drugs (efficacy and/or safety) following treatment with an appropriate dose and of adequate duration in the opinion of the investigator
  • Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or between Screening and Baseline, or plans to travel across different time zones during the study
  • Performed shift work in the 2 weeks before Screening, or between Screening and Baseline, or plans to do during the study
  • A positive drug test at Screening, Run-in, or Baseline, or unwilling to refrain from use of recreational drugs during the study
  • Currently enrolled in another clinical trial or used any investigational drug or device within 30 days or 5* the half-life, whichever is longer, preceding informed consent
  • Previously participated in any clinical trial of lemborexant

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

South Korea9 sites

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • Gacheon University Gil Medical Centre

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Konkuk University Medical Center

    Seoul, 05030

  • Samsung Medical Center

    Seoul, 06351

  • Korea University Guro Hospital

    Seoul, 08308

  • Kyung Hee University Hospital at Gangdong

    Seoul, 5278

  • The Catholic University of Korea, St. Vincent Hospital

    Suwon, Gyeonggi-do, 16247

Other trials in South Korea

About this study

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Pharmacodynamics of Lemborexant in Korean Subjects With Insomnia Disorder

The primary purpose of the study is to evaluate the treatment difference between lemborexant 5 milligram (mg) (LEM5) and placebo (PBO) on latency to persistent sleep (LPS) using polysomnography (PSG) on Day 30.

Being tested
Lemborexant, PBO
Keywords
Lemborexant, E2006, Dayvigo
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LemborexantDrug

    Also called E2006, Dayvigo

    Lemborexant oral tablet.

  • PBOOther

    Lemborexant-matched PBO tablet.

Study groups in NCT05594589
Study groupRoleWhat they receive
Lemborexant 5 mg (LEM5)ExperimentalParticipants will receive one LEM5 tablet, orally, once daily for 30 nights (Day 1 up to Day 30) on each night approximately 5 minutes before participants intend to try to sleep.
Receives: Drug: Lemborexant
Lemborexant 10 mg (LEM10)ExperimentalParticipants will receive one lemborexant 10 mg (LEM10) tablet, orally, once daily for 30 nights (Day 1 up to Day 30) on each night approximately 5 minutes before participants intend to try to sleep.
Receives: Drug: Lemborexant
Placebo (PBO)Placebo comparatorParticipants will receive one lemborexant-matched PBO tablet, orally, once daily for 30 nights (Day 1 to Day 30) on each night approximately 5 minutes before participants intend to try to sleep.
Receives: Other: PBO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment Period: Change From Baseline in Latency to Persistent Sleep (LPS) on Day 30 of Lemborexant 5 mg Compared to Placebo

    LPS is the duration of time measured from lights off to the first epoch of 20 consecutive epochs of non-wakefulness as measured by polysomnography (PSG).

    Measured: Baseline, at Day 30

Secondary outcomes (8)

  1. Treatment Period: Change From Baseline in LPS on Day 30 of Lemborexant 10 mg Compared to Placebo

    LPS is the duration of time measured from lights off to the first epoch of 20 consecutive epochs of non-wakefulness as measured by PSG.

    Measured: Baseline, at Day 30

  2. Treatment Period: Change From Baseline in Objective Sleep Efficiency (SE) on Day 30 of Lemborexant 5 mg Compared to Placebo

    SE is defined as total sleep time (TST) divided by time spent in bed multiplied by 100 as measured by PSG. TST is duration of sleep from sleep onset until terminal awakening.

    Measured: Baseline, at Day 30

  3. Treatment Period: Change From Baseline in Objective SE on Day 30 of Lemborexant 10 mg Compared to Placebo

    SE is defined as TST divided by time spent in bed multiplied by 100 as measured by PSG. TST is duration of sleep from sleep onset until terminal awakening.

    Measured: Baseline, at Day 30

  4. Treatment Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    A TEAE was defined as an adverse event (AE) that emerges during treatment (on or after the first dose of study drug up to 28 days after the participant's last dose), having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE was continuous.

    Measured: From start of study drug administration at Day 1 up to Day 58

  5. Treatment Period: Number of Participants With Clinically Significant Abnormal Laboratory Parameters

    The laboratory parameters included hematology, chemistry, and urinalysis. Any abnormality in the laboratory results which are deemed clinically significant by the investigator were reported.

    Measured: From start of study drug administration at Day 1 up to Day 58

  6. Treatment Period: Number of Participants With Clinically Significant Abnormal Vital Signs Values

    Vital sign measurement included systolic and diastolic blood pressure, pulse rate, respiratory rate and body temperature. Any abnormality in vital signs which are deemed clinically significant by the investigator were reported.

    Measured: From start of study drug administration at Day 1 up to Day 58

  7. Treatment Period: Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings

    Any abnormality in ECG assessments which were deemed clinically significant by the investigator were reported.

    Measured: From start of study drug administration at Day 1 up to Day 58

  8. Treatment Period: Plasma Concentrations of Lemborexant and Its Metabolites (M4, M9, and M10)

    Plasma concentrations of lemborexant and its metabolites M4, M9, and M10 were reported.

    Measured: Within 2 hours pre-dose on Day 30; At 1 and 1.5 hours after morning waketime on Day 31

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2022
  2. Study start30 Nov 2022
  3. Primary completion26 Apr 2024
  4. Study completion24 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05594589
Sponsor's protocol ID
E2006-J082-204
Status last verified
May 2025
First submitted
21 Oct 2022
Last updated
3 Jul 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lemborexant and PBO in people with Sleep Initiation and Maintenance Disorders, run by Eisai Co., Ltd. at 9 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Period: Change From Baseline in Latency to Persistent Sleep (LPS) on Day 30 of Lemborexant 5 mg Compared to Placebo (time frame: Baseline, at Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05594589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.

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