A Study of Lemborexant in Chinese Participants With Insomnia Disorder

NCT04549168 | Completed Phase 3 Results

• 1 other identifier: E2006-J086-311
• Study Type: interventional
• Target: 194
• Locations: 2 countries
• Sites: 23

Brief 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.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Insomnia disorder; Lemborexant; Chinese Participants; E2006

Outcome Measures

Primary Outcomes (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.

  Baseline, Days 29 and 30

Secondary Outcomes (13)

• 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

  Baseline, Days 29 and 30

• 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

  Baseline, Days 29 and 30

• 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

  Baseline, Nights 24 to 30

• 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

  Baseline, Nights 24 to 30

• 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

  Baseline, Nights 24 to 30

Study Arms (2)

Lemborexant 10 mg

EXPERIMENTAL

Participants 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.

Drug: Lemborexant

Placebo

PLACEBO COMPARATOR

Participants 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.

Drug: Placebo

Interventions

Lemborexant DRUG

Lemborexant 10 mg tablet.

Also known as: E2006

Lemborexant 10 mg

Placebo DRUG

Placebo tablet matched to lemborexant 10 mg tablet.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (23)

Beijing Tiantan Hosptial, Capital Medical University

Beijing, Beijing Municipality, China

Location

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

Location

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Henan Mental Health Center

Xinxiang, Henan, China

Location

Wuhan Mental Health Center

Wuhan, Hubei, China

Location

Nanjing Brain Hosptial

Nanjing, Jiangsu, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Jilin First University Affiliated Hospital

Changchun, Jilin, China

Location

Inner Mongolia Autonomous Region Peoples Hospital

Hohhot, Mongolia, China

Location

Tangdu Hospital

Xi'an, Shaanxi, China

Location

Shandong Provincial Qianfushan Hospital

Jinan, Shandong, China

Location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shannxi, China

Location

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, China

Location

Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

Taoyuan, Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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. 2025 Dec 18;139:108722. doi: 10.1016/j.sleep.2025.108722. Online ahead of print.

  PMID: 41442783 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Eisai Inquiry Service
• Organization: Eisai Co., Ltd.

eisai-chiken_hotline@hhc.eisai.co.jp

none

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: November 6, 2020
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

TW (2); CN (21)