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

Eisai Co., Ltd.23 sites in 2 countries194 target enrollmentNovember 6, 2020

ConditionsSleep Initiation and Maintenance Disorders

InterventionsLemborexant Placebo

DrugsLemborexant Placebo

Overview

Phase: Phase 3
Intervention: Lemborexant
Conditions: Sleep Initiation and Maintenance Disorders
Sponsor: Eisai Co., Ltd.
Enrollment: 194
Locations: 23
Primary Endpoint: 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
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

November 6, 2020

End Date

March 17, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eisai Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Arms & Interventions

Lemborexant 10 mg

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.

Intervention: Lemborexant

Placebo

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.

Intervention: Placebo

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

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)
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(Baseline, Nights 1 and 2)
Change From Baseline of Mean Sleep Efficiency Over the First 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo(Baseline, Nights 1 and 2)
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(Baseline, Nights 1 and 2)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(From the first dose of study drug up to 44 days)
Change From Baseline in Insomnia Severity Index (ISI) Total Score After 1 Month of Treatment With Lemborexant 10 mg Compared to Placebo(Baseline to Day 31)
Change From Baseline in Insomnia Severity Index Daytime Functioning Score After 1 Month of Treatment With Lemborexant 10 mg Compared to Placebo(Baseline to Day 31)
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(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)
Change From Baseline in Mean Morning Residual Sleepiness Score Evaluated During Treatment and Follow-up Periods(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)