A Multicenter, Randomized, Double-blind, Placebo-controll... | NCT01995838 | Trialant
NCT01995838
Sponsor
Eisai Inc.
Status
Completed
Last Update Posted
Jan 31, 2020Actual
Enrollment
291Actual
Phase
Phase 2
Conditions
Chronic Insomnia
Adults
Elderly
Interventions
E2006
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01995838
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
E2006-G000-201
Secondary IDs
Not provided
Brief Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia
Acronym
Not provided
Organization
Eisai Inc.INDUSTRY
Status Module
Record Verification Date
Nov 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 13, 2013Actual
Primary Completion Date
Apr 29, 2014Actual
Completion Date
Apr 29, 2014Actual
First Submitted Date
Nov 13, 2013
First Submission Date that Met QC Criteria
Nov 21, 2013
First Posted Date
Nov 27, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 5, 2018
Results First Submitted that Met QC Criteria
Jan 22, 2020
Results First Posted Date
Jan 31, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 25, 2015
Certification/Extension First Submitted that Passed QC Review
Jun 25, 2015
Certification/Extension First Posted Date
Jul 20, 2015Estimated
Last Update Submitted Date
Jan 22, 2020
Last Update Posted Date
Jan 31, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eisai Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, parallel-group, Bayesian adaptive, dose response study in subjects with chronic insomnia. Subjects will be randomized to 1 of 6 doses of E2006 (1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or 25 mg) or placebo.
Detailed Description
The study will have 2 phases, Prerandomization and Randomization. The Prerandomization Phase will last up to 21 days and will consist of a Screening Period (Days -21 to -2) and a Baseline Period (Day -1). Following the Baseline Period, all eligible subjects will be randomized, in a double-blind manner, to receive E2006 or placebo for 15 nights during the Treatment Period (Days 1 to 15), then all subjects will receive placebo, in a single-blind manner, for 2 nights (Days 16 to 17) during the Rebound Insomnia Assessment Period (Days 16 to 18). Subjects will not receive any treatment during the Follow-up Period (Days 19 to 29). All subjects will come to the clinic for screening procedures. During the Screening Period, subjects will complete the Sleep Diary each day. Polysomnographic sleep will be measured during the Screening Period on 2 consecutive nights between Day -9 and Day -3. These 8-hour polysomnograms (PSGs) will start at the median habitual bedtime calculated from responses on the Sleep Diary completed 7 days immediately prior to the first PSG night. Subjects may leave the clinic between the screening/baseline PSG nights.
Conditions Module
Conditions
Chronic Insomnia
Adults
Elderly
Keywords
Chronic Insomnia
Adults
Elderly
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
291Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
E2006
Experimental
E2006 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or 25 mg, in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights
Drug: E2006
Placebo
Placebo Comparator
E2006-matched placebo in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
E2006
Drug
E2006 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or 25 mg, in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights
E2006
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Probability of Having Utility Function Greater Than (>) 1 Based on Bayesian Analysis
The utility of a dose was a function of both Sleep Efficiency (SE) and Karolinska Sleepiness Scale (KSS), constructed by specifying the 1-dimensional component for each outcome measure and then combining them multiplicatively. Sufficient utility was defined as a probability of having utility function >1. Probability of having utility function >1 at the end of study visit (full analysis) was reported.
Baseline up to Day 3
Mean Change From Baseline in Karolinska Sleepiness Scale (KSS) Score at End of Treatment
The KSS was used to measure next-day residual effects at prespecified time points. The KSS was a 9-point scale on which the participant rated their sleepiness from 1 (extremely alert) to 9 (extremely sleepy/fighting sleep), where higher scores indicated an increase in sleepiness. The end of treatment score was calculated by the mean scores at the timepoint at 1 hour after morning wake time of Day 15 and 16.
1 hour after morning wake time at Baseline and Days 15-16
Secondary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline in Sleep Efficiency (SE) After Dosing on Days 1-2 and Days 14-15
Sleep efficiency was calculated as total sleep time divided by time spent in bed multiplied by 100. An increase in SE indicated improvement in sleeping, such that, the participant spends more time in bed asleep. Mean scores of Days 1-2 and Days 14-15 were used to evaluate change from baseline.
Baseline, Days 1-2, and Days 14-15
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
Subjects must meet all of the following criteria to be included in this study:
Male or female subjects age 18 to 80 years at the time of informed consent
Meets the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Insomnia Disorder
Subjective Sleep Onset Latency (sSOL) typically greater than or equal to 30 minutes in the last 4 weeks and/or subjective WASO (sWASO) typically greater than or equal to 60 minutes in the last 4 weeks
Regular time in bed between 6.5 and 9.0 hours
Regular bedtime between 21:00 and 24:00 and regular waketime between 05:00 and 09:00
Insomnia Severity Index (ISI) score greater than or equal to 15 at Screening
Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary completed for 7 nights prior to the first screening/baseline PSG
Objective (PSG) evidence of insomnia at the screening/baseline PSGs as follows:
LPS average greater than or equal to 30 minutes on the 2 consecutive screening/baseline PSGs, with neither night lesser than 15 minutes and/or
WASO average greater than or equal to 30 minutes on the 2 consecutive screening/baseline PSGs, with neither night lesser than 20 minutes
SE average lesser than or equal to 85% on the 2 consecutive screening/baseline PSGs, with neither night greater than 87.5%
Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use two highly effective method of contraception
Male subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation). No sperm donation is allowed during the study period and for 30 days after study drug discontinuation.
Provide written informed consent
Willing to stay in bed for at least 8 hours each night spent in the clinic
Willing and able to comply with all aspects of the protocol
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from this study:
Females who are pregnant (positive beta-human chorionic gonadotropin [B-hCG] test) or breastfeeding
Any lifetime diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, nightmare disorder, sleep terror disorder, sleepwalking disorder, rapid eye movement (REM) behavior disorder, or narcolepsy
Aged 18 to 64 years: Apnea-Hypopnea Index greater than or equal to 10, or Periodic Limb Movements with Arousal Index greater than or equal to 10 on first (diagnostic) PSG night at Screening. Aged 65 to 80 years: Apnea-Hypopnea Index greater than 15, or Periodic Limb Movements with Arousal Index greater than 15 on first (diagnostic) PSG night at Screening
Beck Depression Inventory (BDI) - II score greater than 19 at Screening
Beck Anxiety Inventory (BAI) score greater than 15 at Screening
Used a prescription for any modality of treatment for insomnia, including cognitive behavioral therapy, within 2 weeks prior to screening/baseline PSG, or between Screening and Baseline
Used any medication or sleep aid with known effects on sleep, within 2 weeks prior to screening/baseline PSG, or between Screening and Baseline
Used any prohibited prescription or over-the-counter concomitant medications within the week prior to the first screening/baseline PSG.
Transmeridian travel across 3 or more time zones in the 2 weeks prior to Screening, or plans to travel across 3 or more time zones during study
Unwilling to limit caffeine consumption to lesser than or equal to 600 mg caffeine (approximately four 6-oz cups of caffeinated coffee, or three 12-oz caffeinated sodas, or three 8-oz caffeinated tea beverages), avoid caffeine after 18:00 throughout the study, and avoid caffeine after 13:00 on PSG visits
Unwilling to limit alcohol intake to two or fewer drinks per day throughout the study, or to refrain from any alcohol for 3 hours prior to bedtime while at home throughout the study, or any alcohol on days and nights spent in the clinic. A drink is defined as approximately 12 oz (360 mL) of beer, 4 oz (120 mL) of wine, or 1 oz (30 mL) of liquor.
Any subject that has a known history of malaria or has traveled to a country with known malarial risk (i.e., are designated as 'high' or 'moderate' risk country according to the list available at http://www.cdc.gov/malaria) within the last year.
A prolonged QT/QT interval corrected for heart rate (QTc) interval (QTc greater than 450 ms) as demonstrated by a repeated electrocardiogram (ECG) at Screening (repeated only if initial ECG indicates a QTc interval greater than 450 ms). A history of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolong the QT/QTc interval.
Any suicidal ideation with intent with or without a plan at Screening, Baseline, or within 6 months before Screening (i.e., answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale [C-SSRS])
Any lifetime suicidal behavior (per the Suicidal Behavior Section of the C-SSRS)
Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments
Hypersensitivity to the study drug or any of the excipients
Any history of a medical condition or a concomitant medical condition that in the opinion of the investigator(s) would compromise the subject's ability to safely complete the study
Scheduled for surgery during the study
Known to be human immunodeficiency virus (HIV) positive
Active viral hepatitis (B or C) as demonstrated by positive serology
Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics or prior suicide attempt(s) within approximately the last 2 years
History of drug or alcohol dependency or abuse within approximately the last 2 years
Unwilling to refrain from use of illegal (or legalized) recreational drugs during the study or test positive for illegal (or legalized) drugs at Screening, Baseline, or Day 14
Currently enrolled in another clinical trial or used any investigational drug or device within 30 days or 5x the half-life, whichever is longer preceding informed consent
Murphy P, Moline M, Mayleben D, Rosenberg R, Zammit G, Pinner K, Dhadda S, Hong Q, Giorgi L, Satlin A. Lemborexant, A Dual Orexin Receptor Antagonist (DORA) for the Treatment of Insomnia Disorder: Results From a Bayesian, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study. J Clin Sleep Med. 2017 Nov 15;13(11):1289-1299. doi: 10.5664/jcsm.6800.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 616 participants were screened, of which 325 were screen failures and 291 were randomized to receive study treatment.
Recruitment Details
Participants took part in the study at 23 investigative sites in the United States from 13 Nov 2013 to 29 Apr 2014.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received lemborexant placebo-matching tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
FG001
Lemborexant 1 Milligram (mg)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Placebo
Drug
E2006-matched placebo in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights
Placebo
Mean Change From Baseline in Latency to Persistent Sleep (LPS) After Dosing on Days 1-2 and Days 14-15
LPS was calculated as minutes from lights off to the first 30-second epoch of 20 consecutive epochs of non-wakefulness. A decrease in LPS indicated improvement in time needed to fall asleep. Mean scores of Days 1-2 and Days 14-15 were used to evaluate change from baseline.
Baseline, Days 1-2, and Days 14-15
Mean Change From Baseline in Wakefulness After Sleep Onset (WASO) After Dosing on Days 1-2 and Days 14-15
WASO was calculated as minutes of wakefulness from the onset of persistent sleep until lights on. A decrease in WASO indicated improvement in sleep maintenance. Mean scores of Days 1-2 and Days 14-15 were used to evaluate change from baseline.
Baseline, Days 1-2, and Days 14-15
Potential Habituation Effect: Comparison Between Mean Change From Baseline in SE on Days 1-2 and Mean Change From Baseline in SE on Days 14-15
Potential habituation effect evaluated the possibility of participants being habituated to changes in sleep during the 15 days of treatment with lemborexant. Data reported here was calculated as change from baseline of mean SE of Days 14-15 minus change from baseline of mean SE of Days 1-2. An increase in SE indicated improvement in sleeping, such that, the participant spends more time in bed asleep.
Baseline, Days 1-2, and Days 14-15
Potential Habituation Effect: Comparison Between Mean Change From Baseline in Latency to Persistent Sleep (LPS) on Days 1-2 and Mean Change From Baseline in LPS on Days 14-15
Potential habituation effect evaluated the possibility of participants being habituated to changes in sleep during the 15 days of treatment with lemborexant. Data reported here was calculated as change from baseline of mean LPS of Days 14-15 minus change from baseline of mean LPS of Days 1-2. LPS was calculated as minutes from lights off to the first 30-second epoch of 20 consecutive epochs of non-wakefulness. A decrease in LPS indicated improvement in time needed to fall asleep.
Baseline and Days 1-2, and Days 14-15
Potential Habituation Effect: Comparison Between Mean Change From Baseline in Wakefulness After Sleep Onset (WASO) on Days 1-2 and Mean Change From Baseline in WASO on Days 14-15
Potential habituation effect evaluated the possibility of participants being habituated to changes in sleep during the 15 days of treatment with lemborexant. Data reported here was calculated as change from baseline of mean WASO of Days 14-15 minus change from baseline of mean WASO of Days 1-2. WASO was calculated as minutes of wakefulness from the onset of persistent sleep until lights on. A decrease in WASO indicated improvement in sleep maintenance.
Baseline, Days 1-2, and Days 14-15
Rebound Insomnia: Mean Change From Baseline in Sleep Efficiency (SE) After Dosing on Days 16-17
Rebound insomnia was assessed by comparing the change from baseline of the mean SE on Days 16-17. Sleep efficiency was calculated as total sleep time divided by time spent in bed multiplied by 100. An increase in SE indicated improvement in sleeping, such that, the participant spends more time in bed asleep. A negative change from baseline in SE indicated that SE was worse on Days 16 and 17 than at Baseline, which was considered as evidence for rebound insomnia.
Baseline and Days 16-17
Percentage of Participants With Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
TEAEs: Baseline up to Day 30, SAEs: Baseline up to 30 days after last dose of study drug (up to 47 days)
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Parameters
Baseline up to Day 30
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Baseline up to Day 30
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECGs)
Baseline up to Day 30
Phoenix
Arizona
85006
United States
Fountain Valley
California
92708
United States
Oceanside
California
92054
United States
San Diego
California
92103
United States
San Diego
California
92123
United States
Thousand Oaks
California
91360
United States
Colorado Springs
Colorado
80907
United States
Colorado Springs
Colorado
80909
United States
Brandon
Florida
33511
United States
Hallandale
Florida
33009
United States
Hollywood
Florida
33024
United States
South Miami
Florida
33143
United States
Atlanta
Georgia
30342
United States
Chicago
Illinois
60634
United States
Chicago
Illinois
60637
United States
Overland Park
Kansas
66212
United States
Glen Burnie
Maryland
21061
United States
Las Vegas
Nevada
89104
United States
New York
New York
10019
United States
Raleigh
North Carolina
27612
United States
Cincinnati
Ohio
45212
United States
Cincinnati
Ohio
45255
United States
Philadelphia
Pennsylvania
19118
United States
Columbia
South Carolina
29201-2953
United States
Austin
Texas
78731
United States
Austin
Texas
78744
United States
Dallas
Texas
75230
United States
Vienna
Virginia
22182
United States
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
FG002
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
FG003
Lemborexant 5 mg
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
FG004
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
FG005
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
FG006
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
FG00056 subjects
FG00132 subjects
FG00227 subjects
FG00338 subjects
FG00432 subjects
FG00556 subjects
FG00650 subjects
COMPLETED
FG00051 subjects
FG00130 subjects
FG00227 subjects
FG00336 subjects
FG00430 subjects
FG00554 subjects
FG00645 subjects
NOT COMPLETED
FG0005 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0065 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Participant choice
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Lemborexant 1 mg
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
BG001
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
BG002
Lemborexant 5 mg
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
BG003
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
BG004
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
BG005
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
BG006
Placebo
Participants received lemborexant placebo-matching tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00032
BG00127
BG00238
BG00332
BG00456
BG00550
BG00656
BG007291
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00053.3± 13.0
BG00149.7± 14.3
BG00251.1± 14.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00023
BG00117
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Probability of Having Utility Function Greater Than (>) 1 Based on Bayesian Analysis
The utility of a dose was a function of both Sleep Efficiency (SE) and Karolinska Sleepiness Scale (KSS), constructed by specifying the 1-dimensional component for each outcome measure and then combining them multiplicatively. Sufficient utility was defined as a probability of having utility function >1. Probability of having utility function >1 at the end of study visit (full analysis) was reported.
The full analysis set (FAS) included all participants who were randomized, received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement.
Posted
Number
probability
Baseline up to Day 3
ID
Title
Description
OG000
Lemborexant 1 mg
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
OG001
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG002
Lemborexant 5 mg
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG003
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG004
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG005
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
Units
Counts
Participants
OG00032
OG00127
OG00238
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.8789
OG0010.8920
OG0020.9032
OG003
Primary
Mean Change From Baseline in Karolinska Sleepiness Scale (KSS) Score at End of Treatment
The KSS was used to measure next-day residual effects at prespecified time points. The KSS was a 9-point scale on which the participant rated their sleepiness from 1 (extremely alert) to 9 (extremely sleepy/fighting sleep), where higher scores indicated an increase in sleepiness. The end of treatment score was calculated by the mean scores at the timepoint at 1 hour after morning wake time of Day 15 and 16.
The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, number of participants analyzed (N) represents participants who were available for analysis at the specified timepoints.
Posted
Least Squares Mean
Standard Error
Units on a scale
1 hour after morning wake time at Baseline and Days 15-16
ID
Title
Description
OG000
Lemborexant 1 mg
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
OG001
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
Secondary
Mean Change From Baseline in Sleep Efficiency (SE) After Dosing on Days 1-2 and Days 14-15
Sleep efficiency was calculated as total sleep time divided by time spent in bed multiplied by 100. An increase in SE indicated improvement in sleeping, such that, the participant spends more time in bed asleep. Mean scores of Days 1-2 and Days 14-15 were used to evaluate change from baseline.
The FAS included all participants who were randomized, received at least 1 dose of study drug, had at least 1 post-dose primary efficacy measurement with both baseline and post baseline data available for analysis at each timepoints.
Posted
Least Squares Mean
Standard Error
percentage of sleep time
Baseline, Days 1-2, and Days 14-15
ID
Title
Description
OG000
Lemborexant 1 mg
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
OG001
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG002
Secondary
Mean Change From Baseline in Latency to Persistent Sleep (LPS) After Dosing on Days 1-2 and Days 14-15
LPS was calculated as minutes from lights off to the first 30-second epoch of 20 consecutive epochs of non-wakefulness. A decrease in LPS indicated improvement in time needed to fall asleep. Mean scores of Days 1-2 and Days 14-15 were used to evaluate change from baseline.
The FAS included all participants who were randomized, received at least 1 dose of study drug, had at least 1 post-dose primary efficacy measurement with both baseline and post baseline data available for analysis at each timepoints.
Posted
Mean
Standard Deviation
minutes
Baseline, Days 1-2, and Days 14-15
ID
Title
Description
OG000
Lemborexant 1 mg
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
OG001
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG002
Lemborexant 5 mg
Secondary
Mean Change From Baseline in Wakefulness After Sleep Onset (WASO) After Dosing on Days 1-2 and Days 14-15
WASO was calculated as minutes of wakefulness from the onset of persistent sleep until lights on. A decrease in WASO indicated improvement in sleep maintenance. Mean scores of Days 1-2 and Days 14-15 were used to evaluate change from baseline.
The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, number of participants analyzed (N) represents participants who were available for analysis at the specified timepoints.
Posted
Least Squares Mean
Standard Error
minutes
Baseline, Days 1-2, and Days 14-15
ID
Title
Description
OG000
Lemborexant 1 mg
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
OG001
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG002
Lemborexant 5 mg
Secondary
Potential Habituation Effect: Comparison Between Mean Change From Baseline in SE on Days 1-2 and Mean Change From Baseline in SE on Days 14-15
Potential habituation effect evaluated the possibility of participants being habituated to changes in sleep during the 15 days of treatment with lemborexant. Data reported here was calculated as change from baseline of mean SE of Days 14-15 minus change from baseline of mean SE of Days 1-2. An increase in SE indicated improvement in sleeping, such that, the participant spends more time in bed asleep.
The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percentage of sleep time
Baseline, Days 1-2, and Days 14-15
ID
Title
Description
OG000
Lemborexant 1 mg
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
OG001
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
Secondary
Potential Habituation Effect: Comparison Between Mean Change From Baseline in Latency to Persistent Sleep (LPS) on Days 1-2 and Mean Change From Baseline in LPS on Days 14-15
Potential habituation effect evaluated the possibility of participants being habituated to changes in sleep during the 15 days of treatment with lemborexant. Data reported here was calculated as change from baseline of mean LPS of Days 14-15 minus change from baseline of mean LPS of Days 1-2. LPS was calculated as minutes from lights off to the first 30-second epoch of 20 consecutive epochs of non-wakefulness. A decrease in LPS indicated improvement in time needed to fall asleep.
The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
minutes
Baseline and Days 1-2, and Days 14-15
ID
Title
Description
OG000
Lemborexant 1 mg
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
OG001
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
Secondary
Potential Habituation Effect: Comparison Between Mean Change From Baseline in Wakefulness After Sleep Onset (WASO) on Days 1-2 and Mean Change From Baseline in WASO on Days 14-15
Potential habituation effect evaluated the possibility of participants being habituated to changes in sleep during the 15 days of treatment with lemborexant. Data reported here was calculated as change from baseline of mean WASO of Days 14-15 minus change from baseline of mean WASO of Days 1-2. WASO was calculated as minutes of wakefulness from the onset of persistent sleep until lights on. A decrease in WASO indicated improvement in sleep maintenance.
The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
minutes
Baseline, Days 1-2, and Days 14-15
ID
Title
Description
OG000
Lemborexant 1 mg
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
OG001
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
Secondary
Rebound Insomnia: Mean Change From Baseline in Sleep Efficiency (SE) After Dosing on Days 16-17
Rebound insomnia was assessed by comparing the change from baseline of the mean SE on Days 16-17. Sleep efficiency was calculated as total sleep time divided by time spent in bed multiplied by 100. An increase in SE indicated improvement in sleeping, such that, the participant spends more time in bed asleep. A negative change from baseline in SE indicated that SE was worse on Days 16 and 17 than at Baseline, which was considered as evidence for rebound insomnia.
The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, number of participants analyzed (N) represents participants who were available for analysis at the specified timepoint.
Posted
Least Squares Mean
Standard Error
percentage of sleep time
Baseline and Days 16-17
ID
Title
Description
OG000
Lemborexant 1 mg
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
OG001
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
Secondary
Percentage of Participants With Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
Posted
Number
percentage of participants
TEAEs: Baseline up to Day 30, SAEs: Baseline up to 30 days after last dose of study drug (up to 47 days)
ID
Title
Description
OG000
Lemborexant 1 mg
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
OG001
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG002
Lemborexant 5 mg
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
Secondary
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Parameters
The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
Posted
Number
participants
Baseline up to Day 30
ID
Title
Description
OG000
Lemborexant 1 mg
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
OG001
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG002
Lemborexant 5 mg
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG003
Secondary
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Posted
Number
participants
Baseline up to Day 30
ID
Title
Description
OG000
Lemborexant 1 mg
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
OG001
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG002
Lemborexant 5 mg
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG003
Secondary
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECGs)
The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Posted
Number
participants
Baseline up to Day 30
ID
Title
Description
OG000
Lemborexant 1 mg
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
OG001
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG002
Lemborexant 5 mg
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG003
Time Frame
TEAEs: Baseline up to Day 30, SAEs: Baseline up to 30 days after last dose of study drug (up to 47 days)
Description
Safety analysis set included participants who received at least one dose of study drug and had at least one postdose safety assessment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Lemborexant 1 mg
Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
0
32
0
32
11
32
EG001
Lemborexant 2.5 mg
Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
0
27
0
27
11
27
EG002
Lemborexant 5 mg
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
0
38
0
38
16
38
EG003
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
0
32
0
32
19
32
EG004
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
0
56
0
56
31
56
EG005
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
0
50
1
50
30
50
EG006
Placebo
Participants received lemborexant placebo-matching tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
0
56
1
56
21
56
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hyperkalemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG0030 affected32 at risk
EG0040 affected56 at risk
EG0050 affected50 at risk
EG0061 affected56 at risk
Grand Mal Convulsion
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Somnolence
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected27 at risk
EG0022 affected38 at risk
EG0034 affected32 at risk
EG00410 affected56 at risk
EG00511 affected50 at risk
EG0060 affected56 at risk
Headache
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0003 affected32 at risk
EG0013 affected27 at risk
EG0023 affected38 at risk
EG003
Sleep paralysis
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0021 affected38 at risk
EG003
Rapid eye movements sleep abnormal
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected27 at risk
EG0021 affected38 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0021 affected38 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected27 at risk
EG0021 affected38 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected27 at risk
EG0022 affected38 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected27 at risk
EG0020 affected38 at risk
EG003
Syncope
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Cataplexy
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0021 affected38 at risk
EG003
Grand mal convulsion
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Sedation
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Sleep phase rhythm disturbance
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Migraine
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Hypnagogic hallucination
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0021 affected38 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0022 affected38 at risk
EG003
Elevated mood
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Anger
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Bruxism
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Depression
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Euphoric mood
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Hypervigilance
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Sleep talking
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0021 affected38 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected27 at risk
EG0020 affected38 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0023 affected38 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected27 at risk
EG0021 affected38 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0021 affected38 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Feeling drunk
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Chills
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Pyrexia
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Application site dermatitis
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Asthenia
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Energy increased
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Fatigue
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0021 affected38 at risk
EG003
Irritability
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Malaise
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0021 affected38 at risk
EG003
Application site bruise
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected27 at risk
EG0020 affected38 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Influenza
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0021 affected38 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected27 at risk
EG0020 affected38 at risk
EG003
Blood pressure increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected27 at risk
EG0020 affected38 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Eye pain
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0021 affected38 at risk
EG003
Vision blurred
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Abnormal sensation in eye
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Blepharospasm
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Excessive eye blinking
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected27 at risk
EG0020 affected38 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0021 affected38 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Hyperacusis
Ear and labyrinth disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0021 affected38 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Diaphragmatic disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0021 affected38 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected27 at risk
EG0020 affected38 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Eisai Medical Services
Eisai Inc.
1-888-422-4743
esi_medinfo@eisai.com
ID
Term
D007319
Sleep Initiation and Maintenance Disorders
Ancestor Terms
ID
Term
D020919
Sleep Disorders, Intrinsic
D020920
Dyssomnias
D012893
Sleep Wake Disorders
D009422
Nervous System Diseases
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
FG0061 subjects
0 subjects
FG0050 subjects
FG0061 subjects
1 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0051 subjects
FG0062 subjects
47.1
± 13.7
BG00444.0± 14.6
BG00548.9± 13.4
BG00647.1± 15.6
BG00748.3± 14.4
23
BG00320
BG00432
BG00531
BG00636
BG007182
Male
BG0009
BG00110
BG00215
BG00312
BG00424
BG00519
BG00620
BG007109
32
OG00456
OG00550
0.9406
OG0040.9866
OG0050.9675
OG002
Lemborexant 5 mg
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG003
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG004
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG005
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG006
Placebo
Participants received lemborexant placebo-matching tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
Units
Counts
Participants
OG00031
OG00127
OG00237
OG00331
OG00454
OG00546
OG00651
Title
Denominators
Categories
Title
Measurements
OG0000.29± 0.219
OG001-0.10± 0.234
OG0020.20± 0.200
OG003-0.22± 0.219
OG0040.16± 0.166
OG0050.45± 0.180
OG006-0.23± 0.170
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
ANCOVA
Baseline value and treatment as covariates.
0.0651
LS Mean Difference
0.51
2-Sided
95
-0.03
1.06
Superiority
OG001
OG006
ANCOVA
Baseline value and treatment as covariates.
0.6490
LS Mean Difference
0.13
2-Sided
95
-0.44
0.70
Superiority
OG002
OG006
ANCOVA
Baseline value and treatment as covariates.
0.1059
LS Mean Difference
0.43
2-Sided
95
-0.09
0.94
Superiority
OG003
OG006
ANCOVA
Baseline value and treatment as covariates.
0. 9818
LS Mean Difference
0.01
2-Sided
95
-0. 54
0.55
Superiority
OG004
OG006
ANCOVA
Baseline value and treatment as covariates.
0. 1071
LS Mean Difference
0.38
2-Sided
95
-0.08
0.85
Superiority
OG005
OG006
ANCOVA
Baseline value and treatment as covariates.
0.0063
LS Mean Difference
0.68
2-Sided
95
0.19
1.17
Superiority
Lemborexant 5 mg
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG003
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG004
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG005
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG006
Placebo
Participants received lemborexant placebo-matching tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
Units
Counts
Participants
OG00032
OG00127
OG00238
OG00332
OG00456
OG00550
OG00656
Title
Denominators
Categories
Days 1-2
Title
Measurements
OG00018.72± 1.366
OG00118.59± 1.487
OG00219.89± 1.250
OG00322.25± 1.361
OG00424.22± 1.029
OG00524.28± 1.091
OG00614.16± 1.031
Days 14-15
Title
Measurements
OG00014.43± 1.428
OG00118.02± 1.528
OG00219.85± 1.302
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Days 1-2
ANCOVA
Baseline value and treatment as covariates.
0.0083
LS Mean Difference
4.57
2-Sided
95
1.19
7.94
Superiority
OG001
OG006
Days 1-2
ANCOVA
Baseline value and treatment as covariates.
0.0151
LS Mean Difference
4.44
2-Sided
95
0.86
8.01
Superiority
OG002
OG006
Days 1-2
ANCOVA
Baseline value and treatment as covariates.
0.0005
LS Mean Difference
5.74
2-Sided
95
2.54
8.93
Superiority
OG003
OG006
Days 1-2
ANCOVA
<0.0001
LS Mean Difference
8.09
2-Sided
95
4.73
11.45
Superiority
OG004
OG006
Days 1-2
ANCOVA
Baseline value and treatment as covariates.
<0.0001
LS Mean Difference
10.06
2-Sided
95
7.20
12.93
Superiority
OG005
OG006
Days 1-2
ANCOVA
Baseline value and treatment as covariates.
<0.0001
LS Mean Difference
10.13
2-Sided
95
7.18
13.08
Superiority
OG000
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
0.8505
LS Mean Difference
0.34
2-Sided
95
-3.22
3.90
Superiority
OG001
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
0.0380
LS Mean Difference
3.94
2-Sided
95
0.22
7.66
Superiority
OG002
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
0.0008
LS Mean Difference
5.76
2-Sided
95
2.40
9.12
Superiority
OG003
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
<0.0001
LS Mean Difference
7.78
2-Sided
95
4.24
11.32
Superiority
OG004
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
<0.0001
LS Mean Difference
7.89
2-Sided
95
4.86
10.92
Superiority
OG005
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
<0.0001
LS Mean Difference
8.87
2-Sided
95
5.72
12.02
Superiority
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG003
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG004
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG005
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG006
Placebo
Participants received lemborexant placebo-matching tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
Units
Counts
Participants
OG00032
OG00127
OG00238
OG00332
OG00456
OG00550
OG00656
Title
Denominators
Categories
Days 1-2
Title
Measurements
OG000-42.92± 41.855
OG001-52.74± 50.149
OG002-47.72± 39.389
OG003-46.80± 46.106
OG004-51.59± 36.728
OG005-50.16± 43.140
OG006-22.90± 44.457
Days 14-15
Title
Measurements
OG000-41.23± 34.618
OG001-54.24± 44.918
OG002-51.86± 41.994
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Days 1-2
ANCOVA
Baseline value and treatment as covariates.
0.1407
Geometric Mean Ratio
0.77
2-Sided
95
0.54
1.09
Superiority
OG001
OG006
ANCOVA
Baseline value and treatment as covariates.
0.0018
Geometric Mean Ratio
0.55
2-Sided
95
0.38
0.80
Superiority
Days 1-2
OG002
OG006
Days 1-2
ANCOVA
Baseline value and treatment as covariates.
0.0025
Geometric Mean Ratio
0.60
2-Sided
95
0.43
0.83
Superiority
OG003
OG006
Days 1-2
ANCOVA
Baseline value and treatment as covariates.
0.0006
Geometric Mean Ratio
0.54
2-Sided
95
0.38
0.76
Superiority
OG004
OG006
Days 1-2
ANCOVA
Baseline value and treatment as covariates.
<0.0001
Geometric Mean Ratio
0.52
2-Sided
95
0.38
0.70
Superiority
OG005
OG006
Days 1-2:
ANCOVA
Baseline value and treatment as covariates.
<0.0001
Geometric Mean Ratio
0.39
2-Sided
95
0.29
0.54
Superiority
OG000
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
0.1158
Geometric Mean Ratio
0.73
2-Sided
95
0.49
1.08
Superiority
OG001
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
0.0010
Geometric Mean Ratio
0.49
2-Sided
95
0.33
0.75
Superiority
OG002
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
<0.0001
Geometric Mean Ratio
0.47
2-Sided
95
0.32
0.69
Superiority
OG003
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
<0.0001
Geometric Mean Ratio
0.32
2-Sided
95
0.21
0.47
Superiority
OG004
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
<0.0001
Geometric Mean Ratio
0.41
2-Sided
95
0.29
0.57
Superiority
OG005
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
<0.0001
Geometric Mean Ratio
0.34
2-Sided
95
0.24
0.48
Superiority
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG003
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG004
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG005
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG006
Placebo
Participants received lemborexant placebo-matching tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
Units
Counts
Participants
OG00032
OG00127
OG00238
OG00332
OG00456
OG00550
OG00656
Title
Denominators
Categories
Days 1-2
ParticipantsOG00032
ParticipantsOG00127
ParticipantsOG00238
ParticipantsOG00332
ParticipantsOG00456
ParticipantsOG00550
ParticipantsOG00656
Title
Measurements
OG000-52.11± 5.441
OG001-43.33± 5.915
OG002-52.29± 5.423
OG003
Days 14-15
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00237
ParticipantsOG00331
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Days 1-2
ANCOVA
Baseline value and treatment as covariates.
0.1050
LS Mean Difference
-11.08
2-Sided
95
-24.48
2.33
Superiority
OG001
OG006
Days 1-2
ANCOVA
Baseline value and treatment as covariates.
0.7501
LS Mean Difference
-2.29
2-Sided
95
-16.46
11.87
Superiority
OG002
OG006
Days 1-2
ANCOVA
Baseline value and treatment as covariates.
0.0818
LS Mean Difference
-11.26
2-Sided
95
-23.94
1.43
Superiority
OG003
OG006
Days 1-2
ANCOVA
Baseline value and treatment as covariates.
0.0038
LS Mean Difference
-19.81
2-Sided
95
-33.18
-6.43
Superiority
OG004
OG006
Days 1-2
ANCOVA
Baseline value and treatment as covariates.
<0.0001
LS Mean Difference
-29.34
2-Sided
95
-40.75
17.93
Superiority
OG005
OG006
Days 1-2
ANCOVA
Baseline value and treatment as covariates.
<0.0001
LS Mean Difference
-25.84
2-Sided
95
-37.59
-14.09
Superiority
OG000
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
0.4642
LS Mean Difference
0.4642
2-Sided
95
-9.60
20.98
Superiority
OG001
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
0.7754
LS Mean Difference
-2.31
2-Sided
95
-18.27
13.64
Superiority
Baseline value and treatment as covariates.
OG002
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
0.1461
LS Mean Difference
-10.69
2-Sided
95
-25.14
3.75
Superiority
OG003
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
0.0581
LS Mean Difference
-14.73
2-Sided
95
-29.97
0.51
Superiority
OG004
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
0.0019
LS Mean Difference
-20.80
2-Sided
95
-33.86
-7.74
Superiority
OG005
OG006
Days 14-15
ANCOVA
Baseline value and treatment as covariates.
0.0020
LS Mean Difference
-21.52
2-Sided
95
-35.12
-7.91
Superiority
OG002
Lemborexant 5 mg
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG003
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG004
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG005
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG006
Placebo
Participants received lemborexant placebo-matching tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
Units
Counts
Participants
OG00031
OG00127
OG00237
OG00331
OG00454
OG00546
OG00652
Title
Denominators
Categories
Title
Measurements
OG000-4.04± 8.194
OG001-0.54± 10.505
OG0020.06± 6.888
OG003-0.68± 6.883
OG004-2.33± 6.600
OG005-2.15± 5.388
OG006-1.05± 7.192
OG002
Lemborexant 5 mg
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG003
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG004
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG005
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG006
Placebo
Days 1 to 15: Three E2006-matched placebo tablets were taken orally, 30 minutes before bedtime, each night for 15 consecutive nights. Days 16 to 18: Two E2006-matched placebo tablets were taken for 2 consecutive nights. Days 10 to 30: No study drug, E2006 or placebo, was taken.
Units
Counts
Participants
OG00031
OG00127
OG00237
OG00331
OG00454
OG00546
OG00652
Title
Denominators
Categories
Title
Measurements
OG0002.71± 24.333
OG001-1.50± 22.120
OG002-4.60± 22.337
OG003-7.93± 17.415
OG004-1.11± 24.568
OG0051.38± 12.046
OG0060.57± 40.855
OG002
Lemborexant 5 mg
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG003
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG004
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG005
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG006
Placebo
Participants received lemborexant placebo-matching tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
Units
Counts
Participants
OG00031
OG00127
OG00236
OG00331
OG00454
OG00545
OG00652
Title
Denominators
Categories
Title
Measurements
OG00017.98± 34.299
OG0012.16± 44.054
OG0022.68± 29.726
OG0039.30± 25.890
OG00411.76± 26.187
OG0059.28± 23.119
OG0065.99± 31.417
OG002
Lemborexant 5 mg
Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG003
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG004
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG005
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG006
Placebo
Days 1 to 15: Three E2006-matched placebo tablets were taken orally, 30 minutes before bedtime, each night for 15 consecutive nights. Days 16 to 18: Two E2006-matched placebo tablets were taken for 2 consecutive nights. Days 10 to 30: No study drug, E2006 or placebo, was taken.
Units
Counts
Participants
OG00031
OG00127
OG00236
OG00331
OG00454
OG00545
OG00652
Title
Denominators
Categories
Title
Measurements
OG00013.12± 1.661
OG00115.53± 1.777
OG00217.67± 1.535
OG00313.78± 1.653
OG00418.58± 1.253
OG00517.12± 1.374
OG00616.17± 1.280
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Days 16-17
ANCOVA
Baseline value and treatment as covariates.
0.1483
LS Mean Difference
-3.05
2-Sided
95
-7.20
1.09
Superiority
OG001
OG006
Days 16-17
ANCOVA
Baseline value and treatment as covariates.
0.7720
LS Mean Difference
-0.64
2-Sided
95
-4.96
3.69
Superiority
OG002
OG006
Days 16-17
ANCOVA
Baseline value and treatment as covariates.
0.4548
LS Mean Difference
1.50
2-Sided
95
-2.44
5.44
Superiority
OG003
OG006
Days 16-17
ANCOVA
Baseline value and treatment as covariates.
0.2530
LS Mean Difference
-2.39
2-Sided
95
-6.51
1.72
Superiority
OG004
OG006
Days 16-17
ANCOVA
Baseline value and treatment as covariates.
0.1794
LS Mean Difference
2.41
2-Sided
95
-1.11
5.93
Superiority
OG005
OG006
Days 16-17
ANCOVA
Baseline value and treatment as covariates.
0.6148
LS Mean Difference
0.94
2-Sided
95
-2.74
4.63
Superiority
OG003
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG004
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG005
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG006
Placebo
Days 1 to 15: Three E2006-matched placebo tablets were taken orally, 30 minutes before bedtime, each night for 15 consecutive nights. Days 16 to 18: Two E2006-matched placebo tablets were taken for 2 consecutive nights. Days 10 to 30: No study drug, E2006 or placebo, was taken.
Units
Counts
Participants
OG00032
OG00127
OG00238
OG00332
OG00456
OG00550
OG00656
Title
Denominators
Categories
TEAE
Title
Measurements
OG00034.4
OG00140.7
OG00242.1
OG00359.4
OG00455.4
OG00560.0
OG00637.5
SAE
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG004
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG005
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG006
Placebo
Days 1 to 15: Three E2006-matched placebo tablets were taken orally, 30 minutes before bedtime, each night for 15 consecutive nights. Days 16 to 18: Two E2006-matched placebo tablets were taken for 2 consecutive nights. Days 10 to 30: No study drug, E2006 or placebo, was taken.
Units
Counts
Participants
OG00032
OG00127
OG00238
OG00332
OG00456
OG00550
OG00656
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG004
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG005
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG006
Placebo
Days 1 to 15: Three E2006-matched placebo tablets were taken orally, 30 minutes before bedtime, each night for 15 consecutive nights. Days 16 to 18: Two E2006-matched placebo tablets were taken for 2 consecutive nights. Days 10 to 30: No study drug, E2006 or placebo, was taken.
Units
Counts
Participants
OG00032
OG00127
OG00238
OG00332
OG00456
OG00550
OG00656
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Lemborexant 10 mg
Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG004
Lemborexant 15 mg
Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG005
Lemborexant 25 mg
Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
OG006
Placebo
Days 1 to 15: Three E2006-matched placebo tablets were taken orally, 30 minutes before bedtime, each night for 15 consecutive nights. Days 16 to 18: Two E2006-matched placebo tablets were taken for 2 consecutive nights. Days 10 to 30: No study drug, E2006 or placebo, was taken.