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Sleep Initiation and Maintenance DisordersPhase 3NCT04549168

A Study of Lemborexant in Chinese Participants With Insomnia Disorder

A Phase 3 study testing Lemborexant in people with Sleep Initiation and Maintenance Disorders, run by Eisai Co., Ltd. at 23 sites in 2 countries.

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 this study is to confirm using polysomnography (PSG) that lemborexant 10 milligram (mg) is superior to placebo on objective sleep onset as assessed by latency to persistent sleep (LPS) during the last 2 nights of 1 month of treatment in participants with insomnia disorder. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lemborexant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
194 participants
Where
23 sitesin 2 countries
Study dates
6 Nov 2020to 17 Mar 2023
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following criteria to be included in this study:
  • Chinese male or female, age 18 years or older, at the time of informed consent (in Taiwan only participants with age 20 years or older are eligible)
  • Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Insomnia Disorder, as follows:
  • Complains of dissatisfaction with night time sleep, in the form of 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
Show all 18Show fewer
  • Associated with complaint of daytime impairment
  • At Screening: History of sSOL >=30 minutes on at least 3 nights per week in the previous 4 weeks and/or sWASO >=60 minutes on at least 3 nights per week in the previous 4 weeks
  • At Screening: Reports regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours
  • At second Screening Visit (Visit 2a) and Run-in Visit (Visit 3a): Sleep diary confirms regular bedtime, defined as the time the participant attempts to sleep, between 21:00 and 01:00 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 10:00 on at least 5 of the final 7 nights
  • At Screening and Baseline: ISI score >=15
  • Confirmation of current insomnia symptoms, as determined from responses on the sleep diary on the 7 most recent mornings before the first PSG during Screening Period (Visit 2a) and Run-in visit (Visit 3a), such that sSOL >=30 minutes on at least 3 of the 7 nights and/or sWASO >=60 minutes on at least 3 of the 7 nights
  • At the second Screening Visit (Visit 2a) and the Run-in visit (Visit 3a): 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 Visit, 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 the Run-in Period, objective (PSG) evidence of insomnia as follows:
  • LPS average >=30 minutes on the 2 consecutive Baseline PSGs, with neither night <20 minutes and/or
  • WASO average >=60 minutes on the two consecutive Baseline PSGs, with neither night <45 minutes
  • Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night
  • Willing not to start a behavioral or other treatment program for the treatment of insomnia during the participant's participation in the study

Who cannot join

  • Participants who meet any of the following criteria will be excluded from this study:
  • Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin test). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first 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
  • a contraceptive implant
Show all 41Show fewer
  • an oral contraceptive (participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and 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 participant's safety or interfere with the study assessments
  • A prolonged corrected QT interval by Fredericia's formula (QTcF) interval (QTcF >450 millisecond [ms]) as demonstrated by a repeated electrocardiogram. A history of risk factors for torsade de pointes (for 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 suicidal behavior in the past 10 years
  • Evidence of clinically significant disease (for 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 participant's safety or interfere with the study assessments. Participants for whom a sedating drug would be contraindicated for safety reasons because of the participant's occupation or activities are also excluded
  • Hypersensitivity to lemborexant or to their excipients
  • Scheduled for surgery during the study
  • Known to be human immunodeficiency virus 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 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:
  • Snoring, Tiredness, Observed apnea, high blood Pressure (STOP)-Body mass index (BMI), Age, Neck circumference, and Gender (BANG) score >=5
  • International Restless Legs Scale score >=16
  • Apnea-hypopnea Index >15 or Periodic Limb Movement with Arousal Index >15 as measured on the PSG at the second 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 (for example, making phone calls or preparing and eating food while sleeping)
  • For participants who underwent diagnostic PSG within 1 year before informed consent:
  • Age 18 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 score >19 at Screening
  • Beck Anxiety Inventory 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 participant's 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
  • Excluding 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 first 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 first 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 more than 3 time zones during the study (China mainland will be considered as 1 time zone)
  • 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 half-lives, whichever is longer preceding informed consent
  • Previously participated in any clinical trial of lemborexant

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

China21 sites

  • Beijing Tiantan Hosptial, Capital Medical University

    Beijing, Beijing Municipality

  • Peking University Sixth Hospital

    Beijing, Beijing Municipality

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality

  • Jilin First University Affiliated Hospital

    Changchun, Jilin

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong

  • Inner Mongolia Autonomous Region Peoples Hospital

    Hohhot, Mongolia

  • Shandong Provincial Qianfushan Hospital

    Jinan, Shandong

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Nanjing Brain Hosptial

    Nanjing, Jiangsu

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • First Hospital of Shanxi Medical University

    Taiyuan, Shannxi

  • Tianjin Anding Hospital

    Tianjin, Tianjin Municipality

  • Wuhan Mental Health Center

    Wuhan, Hubei

  • Tangdu Hospital

    Xi'an, Shaanxi

  • Henan Mental Health Center

    Xinxiang, Henan

Other trials in China

Taiwan2 sites

  • Taipei Veterans General Hospital

    Taipei

  • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

    Taoyuan, Taipei

Other trials in Taiwan

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of the Efficacy and Safety of Lemborexant in Chinese Subjects With Insomnia Disorder

The primary purpose of this study is to confirm using polysomnography (PSG) that lemborexant 10 milligram (mg) is superior to placebo on objective sleep onset as assessed by latency to persistent sleep (LPS) during the last 2 nights of 1 month of treatment in participants with insomnia disorder.

Read the detailed description

The study will have 2 phases: the Prerandomization Phase and the Randomization Phase. The Prerandomization Phase will comprise 3 periods that will last up to a maximum of 35 days: a Screening Period, a Run-in Period, and a Baseline Period. The Randomization Phase will comprise a Treatment Period during which participants will be treated for 30 nights (1 month) and a minimum 14-day Follow-up Period before an End of Study (EOS) Visit (up to 54 days). The total study duration for each participant on this study is 89 days.

Being tested
Lemborexant, Placebo
Keywords
Insomnia disorder, Lemborexant, Chinese Participants, E2006
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

    Lemborexant 10 mg tablet.

  • PlaceboDrug

    Placebo tablet matched to lemborexant 10 mg tablet.

Study groups in NCT04549168
Study groupRoleWhat they receive
Lemborexant 10 mgExperimentalParticipants will receive one lemborexant 10 mg tablet, orally, once daily for 30 consecutive nights on each night approximately 5 minutes before participants intends to try to sleep.
Receives: Drug: Lemborexant
PlaceboPlacebo comparatorParticipants will receive one placebo matched to lemborexant 10 mg tablet, orally, once daily for 30 consecutive nights on each night approximately 5 minutes before participants intends to try to sleep.
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline of Mean Latency to Persistent Sleep (LPS) Over the Last 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo

    LPS was defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non- wakefulness as measured by polysomnography (PSG). Change from baseline to average LPS on Days 29 and 30 was reported. The outcome measure was planned to be assessed for randomization phase only.

    Measured: Baseline, Days 29 and 30

Secondary outcomes (13)

  1. Change From Baseline of Mean Objective Sleep Efficiency (SE) Over the Last 2 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo

    SE was defined as percentage (%) of time spent in bed asleep, calculated as total sleep time (TST) divided by interval from lights off until lights on as measured by PSG multiplied by 100. Change from baseline to average SE on Days 29 and 30 was reported. The outcome measure was planned to be assessed for randomization phase only.

    Measured: Baseline, Days 29 and 30

  2. Change From Baseline in Mean Objective Wake After Sleep Onset (WASO) Over the Last 2 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo

    WASO was defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. Change from baseline to average WASO on Days 29 and 30 was reported. The outcome measure was planned to be assessed for randomization phase only.

    Measured: Baseline, Days 29 and 30

  3. Change From Baseline of Subjective Sleep Onset Latency (sSOL) Over the Last 7 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo

    sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. Change from baseline to average sSOL of Nights 24 to 30 was reported. The outcome measure was planned to be assessed for randomization phase only.

    Measured: Baseline, Nights 24 to 30

  4. Change From Baseline of Subjective Sleep Efficiency (sSE) Over the Last 7 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo

    sSE was defined as percentage of subjective total sleep time (sTST) divided by subjective time spent in bed, calculated as the interval from the time the participant reported attempting to sleep until the time participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus subjective wake after sleep onset (sWASO). WASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. Change from baseline to average sSE of Nights 24 to 30 was reported. The outcome measure was planned to be assessed for randomization phase only.

    Measured: Baseline, Nights 24 to 30

  5. Change From Baseline in Subjective Wake After Sleep Onset Over the Last 7 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo

    sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. Change from baseline to average sWASO of Nights 24 to 30 was reported. The outcome measure was planned to be assessed for randomization phase only.

    Measured: Baseline, Nights 24 to 30

  6. Change From Baseline of Mean Latency to Persistent Sleep Over the First 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo

    LPS was defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non- wakefulness as measured by polysomnography. Change from baseline to average LPS on Nights 1 and 2 was reported. The outcome measure was planned to be assessed for randomization phase only.

    Measured: Baseline, Nights 1 and 2

  7. Change From Baseline of Mean Sleep Efficiency Over the First 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo

    SE was defined as percentage of time spent in bed asleep, calculated as total sleep time divided by interval from lights off until lights on as measured by PSG, multiplied by 100. Change from baseline to average SE on Nights 1 and 2 was reported. The outcome measure was planned to be assessed for randomization phase only.

    Measured: Baseline, Nights 1 and 2

  8. Change From Baseline of Mean Wake After Sleep Onset Over the First 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo

    WASO was defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. Change from baseline to average WASO on Nights 1 and 2 was reported. The outcome measure was planned to be assessed for randomization phase only.

    Measured: Baseline, Nights 1 and 2

  9. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    A TEAE was defined as an AE with onset date on or after the first dose of study drug up to 14 days after the last dose of study drug. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening (that is, participant was at immediate risk of death from AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). The outcome measure was planned to be assessed for randomization phase only.

    Measured: From the first dose of study drug up to 44 days

  10. Change From Baseline in Insomnia Severity Index (ISI) Total Score After 1 Month of Treatment With Lemborexant 10 mg Compared to Placebo

    The ISI was a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The 7 dimensions evaluated are severity of: sleep onset; sleep maintenance; early-morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of the sleep problems by others; and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (from 0= no problem, 1= satisfied, 2= moderately satisfied, 3= dissatisfied and 4=very severe problem). Total ISI score was calculated as sum of scores of all 7 individual items, ranging between 0 to 28. A higher score indicated more severe illness. The outcome measure was planned to be assessed for randomization phase only.

    Measured: Baseline to Day 31

  11. Change From Baseline in Insomnia Severity Index Daytime Functioning Score After 1 Month of Treatment With Lemborexant 10 mg Compared to Placebo

    The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The 4 dimensions out of 7 evaluated for daily functioning are severity of: sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of the sleep problems by others; and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (from 0= no problem, 1= satisfied, 2= moderately satisfied, 3= dissatisfied and 4=very severe problem), Daytime Functioning score was calculated as sum of scores of item 4 to 7, ranging between 0 to 16. A higher score indicated more severe illness. The outcome measure was planned to be assessed for randomization phase only.

    Measured: Baseline to Day 31

  12. Number of Participants With Rebound Insomnia on Average of First 3 Nights (Nights 31 to 33), Average of First 7 Nights (Nights 31 to 37), and Average of Last 7 Nights (Nights 38 to 44) During the Follow-up Period

    Rebound insomnia was defined as worsened sleep relative to screening after study drug treatment was completed. Sleep diary data from the follow-up period was compared to sleep diary data from the screening period to assess whether participants experience rebound insomnia. Number of participants with rebound insomnia assessed by sleep diary (sSOL and sWASO) was reported. The outcome measure was planned to be assessed for randomization phase only.

    Measured: First 3 nights (Nights 31 to 33), First 7 nights (Nights 31 to 37) and Last 7 nights (Nights 38 to 44) of Follow up Period

  13. Change From Baseline in Mean Morning Residual Sleepiness Score Evaluated During Treatment and Follow-up Periods

    The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question: "How sleepy/alert do you feel this morning?" Participants rated their sleepiness/alertness level on a Likert scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome. Change from baseline of the morning sleepiness item on the sleep diary for the average of first 7 mornings and the average of last 7 mornings of the Treatment Period; and the average of the first 7 mornings and the average of the last 7 mornings of the Follow-up Period was reported. The outcome measure was planned to be assessed for randomization phase only.

    Measured: Baseline, First 7 mornings (Mornings 1 to 7) and Last 7 mornings (Mornings 24 to 30) of Treatment period; First 7 mornings (Mornings 31 to 37) and Last 7 mornings (Mornings 38 to 44) of Follow-up period

Timeline

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

  1. First posted16 Sep 2020
  2. Study start6 Nov 2020
  3. Primary completion17 Mar 2023
  4. Study completion17 Mar 2023

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04549168
Sponsor's protocol ID
E2006-J086-311
Status last verified
May 2023
First submitted
9 Sep 2020
Last updated
20 Dec 2024
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/.

Publications

  • Mi WF, Wen D, Xu L, Pan J, Gu P, Wang C, Tang J, Zhang L, Liu CF, Yuan C, Wang H, Yamakawa N, Takase T, Moline M, Lu L. A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial of lemborexant in adults with insomnia disorder. Sleep Med. 2026 Mar;139:108722. doi: 10.1016/j.sleep.2025.108722. Epub 2025 Dec 18.

    PubMed 41442783

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lemborexant in people with Sleep Initiation and Maintenance Disorders, run by Eisai Co., Ltd. at 23 sites in 2 countries.

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 18 inclusion and 41 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 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in China, Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 20 Dec 2024). 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?

Change From Baseline of Mean Latency to Persistent Sleep (LPS) Over the Last 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo (time frame: Baseline, Days 29 and 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 NCT04549168, which also lists 1 linked publication.

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 20 Dec 2024.

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