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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

Primary Purpose

Chronic Insomnia, Adults, Elderly

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

E2006

Placebo

About this trial

This is an interventional treatment trial for Chronic Insomnia focused on measuring Chronic Insomnia, Adults, Elderly

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
1. 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
2. WASO average greater than or equal to 30 minutes on the 2 consecutive screening/baseline PSGs, with neither night lesser than 20 minutes
3. 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

E2006

Placebo

Arm Description

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-matched placebo in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Percentage of Participants With Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)

Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Parameters

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECGs)

Full Information

NCT ID

NCT01995838

First Posted

November 13, 2013

Last Updated

January 22, 2020

Sponsor

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01995838

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

November 13, 2013 (Actual)

Primary Completion Date

April 29, 2014 (Actual)

Study Completion Date

April 29, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Insomnia, Adults, Elderly

Keywords

Chronic Insomnia, Adults, Elderly

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

291 (Actual)

8. Arms, Groups, and Interventions

Arm Title

E2006

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

E2006-matched placebo in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights

Intervention Type

Drug

Intervention Name(s)

E2006

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

E2006-matched placebo in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights

Primary Outcome Measure Information:

Title

Probability of Having Utility Function Greater Than (>) 1 Based on Bayesian Analysis

Description

Time Frame

Baseline up to Day 3

Title

Mean Change From Baseline in Karolinska Sleepiness Scale (KSS) Score at End of Treatment

Description

Time Frame

1 hour after morning wake time at Baseline and Days 15-16

Secondary Outcome Measure Information:

Title

Mean Change From Baseline in Sleep Efficiency (SE) After Dosing on Days 1-2 and Days 14-15

Description

Time Frame

Baseline, Days 1-2, and Days 14-15

Title

Mean Change From Baseline in Latency to Persistent Sleep (LPS) After Dosing on Days 1-2 and Days 14-15

Description

Time Frame

Baseline, Days 1-2, and Days 14-15

Title

Mean Change From Baseline in Wakefulness After Sleep Onset (WASO) After Dosing on Days 1-2 and Days 14-15

Description

Time Frame

Baseline, Days 1-2, and Days 14-15

Title

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

Description

Time Frame

Baseline, Days 1-2, and Days 14-15

Title

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

Description

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.

Time Frame

Baseline and Days 1-2, and Days 14-15

Title

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

Description

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.

Time Frame

Baseline, Days 1-2, and Days 14-15

Title

Rebound Insomnia: Mean Change From Baseline in Sleep Efficiency (SE) After Dosing on Days 16-17

Description

Time Frame

Baseline and Days 16-17

Title

Percentage of Participants With Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)

Time Frame

TEAEs: Baseline up to Day 30, SAEs: Baseline up to 30 days after last dose of study drug (up to 47 days)

Title

Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Parameters

Time Frame

Baseline up to Day 30

Title

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Time Frame

Baseline up to Day 30

Title

Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECGs)

Time Frame

Baseline up to Day 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

City

Oceanside

State/Province

California

ZIP/Postal Code

92054

Country

United States

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

City

Thousand Oaks

State/Province

California

ZIP/Postal Code

91360

Country

United States

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80909

Country

United States

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

City

Hallandale Beach

State/Province

Florida

ZIP/Postal Code

33009

Country

United States

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60634

Country

United States

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

City

Glen Burnie

State/Province

Maryland

ZIP/Postal Code

21061

Country

United States

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89104

Country

United States

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45212

Country

United States

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45255

Country

United States

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19118

Country

United States

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29201-2953

Country

United States

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

City

Austin

State/Province

Texas

ZIP/Postal Code

78744

Country

United States

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

City

Vienna

State/Province

Virginia

ZIP/Postal Code

22182

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29065953

Citation

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.

Results Reference

derived

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