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

NCT05594589 | Completed Phase 2 Results

• 1 other identifier: E2006-J082-204
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Lemborexant; E2006; Dayvigo

Outcome Measures

Primary Outcomes (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).

  Baseline, at Day 30

Secondary Outcomes (8)

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

  Baseline, at Day 30

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

  Baseline, at Day 30

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

  Baseline, at Day 30

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

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

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

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

Study Arms (3)

Lemborexant 5 mg (LEM5)

EXPERIMENTAL

Participants 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.

Drug: Lemborexant

Lemborexant 10 mg (LEM10)

EXPERIMENTAL

Participants 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.

Drug: Lemborexant

Placebo (PBO)

PLACEBO COMPARATOR

Participants 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.

Other: PBO

Interventions

Lemborexant DRUG

Lemborexant oral tablet.

Also known as: E2006, Dayvigo

Lemborexant 10 mg (LEM10); Lemborexant 5 mg (LEM5)

PBO OTHER

Lemborexant-matched PBO tablet.

Placebo (PBO)

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (9)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

The Catholic University of Korea, St. Vincent Hospital

Suwon, Gyeonggi-do, 16247, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

Location

Gacheon University Gil Medical Centre

Incheon, 21565, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 5278, South Korea

Location

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: Serena SoYoun Kwon
• Organization: Eisai Korea Inc. Medical department

s-kwon@eisaikorea.com

+82-2-3451-5533

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: November 30, 2022
• Primary Completion: April 26, 2024
• Study Completion: May 24, 2024
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

KR (9)