Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02952820
Registration number
NCT02952820
Ethics application status
Date submitted
31/10/2016
Date registered
2/11/2016
Date last updated
6/02/2020
Titles & IDs
Public title
Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)
Query!
Scientific title
A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder (SUNRISE 2)
Query!
Secondary ID [1]
0
0
2015-001463-39
Query!
Secondary ID [2]
0
0
E2006-G000-303
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Insomnia Disorder
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - lemborexant
Treatment: Drugs - Placebo
Experimental: lemborexant 5 milligrams (mg) - Lemborexant 5 mg will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.
Experimental: lemborexant 10 mg - Lemborexant 10 mg will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.
Placebo Comparator: Placebo matched to lemborexant - Lemborexant-matched placebo will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.
Treatment: Drugs: lemborexant
Treatment: Drugs: Placebo
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6
Query!
Assessment method [1]
0
0
sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.
Query!
Timepoint [1]
0
0
Baseline and Month 6
Query!
Secondary outcome [1]
0
0
Change From Baseline in sSOL at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1 and 3
Query!
Assessment method [1]
0
0
sSOL was defined as estimated minutes from time attempted to sleep to sleep onset.
Query!
Timepoint [1]
0
0
Baseline, (mean of 7 nights [approximately Week 1]), Months 1 and 3
Query!
Secondary outcome [2]
0
0
Change From Baseline in Subjective Sleep Efficiency (sSE) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6
Query!
Assessment method [2]
0
0
sSE was defined as percentage of subjective total sleep time (sTST) divided by subjective time spent in bed, calculated as the interval from the time the participant reported attempting to sleep until the time participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO.
Query!
Timepoint [2]
0
0
Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6
Query!
Secondary outcome [3]
0
0
Change From Baseline in Subjective Wake After Sleep Onset (sWASO) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6
Query!
Assessment method [3]
0
0
sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day.
Query!
Timepoint [3]
0
0
Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6
Query!
Secondary outcome [4]
0
0
Change From Baseline in sTST at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6
Query!
Assessment method [4]
0
0
sTST was defined as minutes of sleep from sleep onset to time stopped trying to sleep for the night.
Query!
Timepoint [4]
0
0
Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6
Query!
Secondary outcome [5]
0
0
Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 6
Query!
Assessment method [5]
0
0
Sleep onset responder was defined as follows: sSOL at study Baseline was greater than or equal to (>=) 30 minutes and mean sSOL at 6 months was less than or equal to (<=) 20 minutes. Sleep maintenance responder was defined as follows: sWASO at study Baseline was >=60 minutes and mean sWASO at 6 months was <=60 minutes and showed a reduction of greater than (>)10 minutes compared to Study Baseline.
Query!
Timepoint [5]
0
0
Month 6
Query!
Secondary outcome [6]
0
0
Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 12
Query!
Assessment method [6]
0
0
Sleep onset responder was defined as follows: sSOL at study Baseline was >=30 minutes and mean sSOL at 6 months was <=20 minutes. Sleep maintenance responder was defined as follows: sWASO at study Baseline was >=60 minutes and mean sWASO at 6 months was <=60 minutes and showed a reduction of > 10 minutes compared to study Baseline.
Query!
Timepoint [6]
0
0
Month 12
Query!
Secondary outcome [7]
0
0
Change From Baseline in Insomnia Severity Index (ISI) Daytime Functioning Score at Months 1, 3, and 6
Query!
Assessment method [7]
0
0
The ISI is a 4-7 item, self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated were: 1. severity of sleep onset; 2. sleep maintenance; 3. early morning awakening problems; 4. sleep dissatisfaction; 5. interference of sleep difficulties with daytime functioning; 6. noticeability of the sleep problems by others; and 7. distress caused by the sleep difficulties. A 5-point Likert scale was used to rate each item (from 0=no problem to 4=very severe problem). Daytime functioning score (sum of items 4 to 7) were analyzed. Higher score indicated severe insomnia problem. The total score range for sum of items is 0-16.
Query!
Timepoint [7]
0
0
Baseline, Months 1, 3, and 6
Query!
Secondary outcome [8]
0
0
Change From Baseline in Fatigue Severity Scale (FSS) Total Score at Months 1, 3 and 6
Query!
Assessment method [8]
0
0
The FSS is a self-reported scale on which participants were instructed to choose a number from 1 to 7 that indicated their degree of agreement with 9 statements about their fatigue where "1" indicates strongly disagree and "7", strongly agree. The FSS total score was the sum of all responses to the 9 questions. Higher total scores and average item scores indicated greater fatigue. Total score range is 9 to 63.
Query!
Timepoint [8]
0
0
Baseline, Months 1, 3 and 6
Query!
Secondary outcome [9]
0
0
Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6
Query!
Assessment method [9]
0
0
The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:
"How sleepy/alert do you feel this morning?" Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome.
Query!
Timepoint [9]
0
0
Baseline, (mean of 7 nights [approximately Week 1]) in placebo-controlled period, Month 1, 3, 6
Query!
Secondary outcome [10]
0
0
Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Active Treatment Period)
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Baseline, First 7 nights (approximately Week 1) in active treatment period
Query!
Secondary outcome [11]
0
0
Change From Screening in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the First and Second 7 Mornings of the Follow-up Period
Query!
Assessment method [11]
0
0
The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:
"How sleepy/alert do you feel this morning?" Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome.
Query!
Timepoint [11]
0
0
Screening, First and second 7 mornings in follow-up period (Week 52 to 54)
Query!
Secondary outcome [12]
0
0
Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at Months 1, 3, 6, 9 and 12
Query!
Assessment method [12]
0
0
The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:
"How sleepy/alert do you feel this morning?" Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome.
Query!
Timepoint [12]
0
0
Baseline, Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [13]
0
0
Rebound Insomnia: Mean sSOL on Each of the First 3 Nights, First 7 Nights, and Last 7 Nights of the Follow-up Period
Query!
Assessment method [13]
0
0
Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.
Query!
Timepoint [13]
0
0
First 3 nights, first and Last 7 nights of the follow up period (Week 52 to 54)
Query!
Secondary outcome [14]
0
0
Rebound Insomnia: Mean sWASO on Each of the First 3 Nights, First 7 Nights, and Last 7 Nights of the Follow-up Period
Query!
Assessment method [14]
0
0
Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day.
Query!
Timepoint [14]
0
0
First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54)
Query!
Secondary outcome [15]
0
0
Rebound Insomnia: Percentage of Participants Whose sSOL Was Longer Than at Screening for First 3 Nights of the Follow-up Period, or Whom Mean sSOL Was Longer Than at Screening for First 7 Nights or Last 7 Nights of the Follow-up Period
Query!
Assessment method [15]
0
0
Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.
Query!
Timepoint [15]
0
0
First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54)
Query!
Secondary outcome [16]
0
0
Rebound Insomnia: Percentage of Participants Whose sWASO is Higher Than at Screening for First 3 Nights of the Follow-up Period, or Whose Mean sWASO is Higher Than at Screening for the First 7 Nights or Last 7 Nights of the Follow-up Period
Query!
Assessment method [16]
0
0
Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day.
Query!
Timepoint [16]
0
0
First 3 nights, First and Last 7 nights of the follow up period (Week 52 to 54)
Query!
Secondary outcome [17]
0
0
Persistence of Effect: Mean Change From Baseline in sSOL, sWASO, and sTST at Months 3, 6, 9, and 12 Compared to Month 1
Query!
Assessment method [17]
0
0
sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At each month beyond Month 1, the change from Baseline was compared to either the lower bound of the 95% CI (for sTST) or the upper bound of the 95% CI (for sSOL and sWASO) at Month 1. Persistence of efficacy was defined as present if the mean change from Baseline at Month 6 was above the lower bound of the 95% CI at Month 1 for sTST and below the upper bound of the 95% CI at Month 1 for sSOL and sWASO.
Query!
Timepoint [17]
0
0
Baseline, Month 1, 3, 6, 9, 12
Query!
Secondary outcome [18]
0
0
Persistence of Effect: Mean Change From Baseline in sSE at Months 3, 6, 9, and 12 Compared to Month 1
Query!
Assessment method [18]
0
0
sSE was defined as percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At each month beyond Month 1, the change from Baseline was compared to the lower bound of the 95% CI at Month 1. Persistence of efficacy was defined as present if the mean change from Baseline at Month 6 was above the lower bound of the 95% CI at Month 1 for sSE.
Query!
Timepoint [18]
0
0
Baseline, Months 1, 3, 6, 9, and 12
Query!
Secondary outcome [19]
0
0
Persistence of Effect: Mean Change From Period 2 Baseline (Month 6) in sSOL, sWASO, and sTST at Months 9 and 12 Compared to Month 7
Query!
Assessment method [19]
0
0
sSOL is defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO: sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At each month beyond Month 7, the change from Baseline was compared to either the lower bound of the 95% CI for sTST or the upper bound of the 95% CI (for sSOL and sWASO) at Month 7. Persistence of effect was defined as present if the mean change from Baseline at Month 12 was above the lower bound of the 95% CI at Month 7 for sTST and below the upper bound of the 95% CI at Month 7 for sSOL and sWASO.
Query!
Timepoint [19]
0
0
Baseline, Month 7, 9, 12
Query!
Secondary outcome [20]
0
0
Persistence of Effect: Mean Change From Period 2 Baseline (Month 6) in sSE at Months 9 and 12 Compared to Month 7
Query!
Assessment method [20]
0
0
sSE: percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the subject got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At each month beyond Month 7, the change from Baseline was compared to the lower bound of the 95% CI for sSE at Month 7. Persistence of effect was defined as present if the mean change from Baseline at Month 12 was above the lower bound of the 95% CI at Month 7 for sSE.
Query!
Timepoint [20]
0
0
Baseline, Month 7, 9, 12
Query!
Secondary outcome [21]
0
0
Persistence of Effect: Mean Change From Study Baseline and Period 2 Baseline (Month 6) in sSOL, sWASO, and sTST at Months 3 and 6 Exposure Compared to Month 1
Query!
Assessment method [21]
0
0
sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO: sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At 3 and 6 months of exposure, the change from Baseline was compared to either the lower bound of the 95% CI for sTST or the upper bound of the 95% CI (for sSOL and sWASO) at 1 month of exposure. Persistence of effect was defined as present if the mean change from Baseline at 6 months of exposure was above the lower bound of the 95% CI at 1 month of exposure for sTST and below the upper bound of the 95% CI at 1 month of exposure for sSOL and sWASO.
Query!
Timepoint [21]
0
0
Baseline, Month 1, 3, 6
Query!
Secondary outcome [22]
0
0
Persistence of Effect: Mean Change From Study Baseline and Period 2 Baseline (Month 6) in sSE at Months 3 and 6 Exposure Compared to Month 1
Query!
Assessment method [22]
0
0
sSE was defined as percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At 3 and 6 months of exposure, the change from Baseline was compared to the lower bound of the 95% CI for sSE at 1 month of exposure. Persistence of effect was defined as present if the mean change from Baseline at 6 months of exposure was above the lower bound of the 95% CI at 1 month of exposure for sSE.
Query!
Timepoint [22]
0
0
Baseline, Month 1, 3, 6
Query!
Eligibility
Key inclusion criteria
- Male or female, age 18 years or older at the time of informed consent
- Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5)
criteria for Insomnia Disorder, as follows:
- Complains of dissatisfaction with nighttime sleep in the form of difficulty
getting to sleep, difficulty staying asleep, and/or awakening earlier in the
morning than desired despite adequate opportunity for sleep
- Frequency of complaint =3 times per week
- Duration of complaint =3 months
- Associated with complaint of daytime impairment
- History of (Subjective Sleep Onset Latency) sSOL =30 minutes on at least 3 nights per
week in the previous 4 weeks and/or subjective Wake after Sleep Onset (sWASO) =60
minutes on at least 3 nights per week in the previous 4 weeks
- History of regular time spent in bed, either sleeping or trying to sleep, between 7
and 9 hours
- Regular bedtime, between 21:00 and 01:00 and regular wake time, the time the
participant gets out of bed for the day, between 05:00 and 10:00
- Insomnia Severity Index (ISI) score =15
- Confirmation of current insomnia symptoms as determined from the Sleep Diary completed
on at least 7 consecutive mornings (minimum 5 of 7 for eligibility), such that sSOL
=30 minutes on at least 3 of the 7 nights and/or sWASO =60 minutes on at least 3 of
the 7 nights
- Confirmation of time spent in bed, as determined from on the Sleep Diary completed on
7 mornings between the first and second screening visit, such that there are not more
than 2 nights with duration of time spent in bed 7 hours and 10 hours
- Confirmation of regular bedtimes and wake times such that the participant has a
regular time spent in bed, either sleeping or trying to sleep, between 7 and 10 hours
for the final 7 nights of the before visit 3.
- Confirmation of regular bedtime between 21:00 and 01:00 and time of getting out of bed
for the day between 05:00 and 10:00 for the final 7 nights of the before visit 3.
- Willing and able to comply with all aspects of the protocol, including staying in bed
for at least 7 hours each night
- Willing to not start a behavioral or other treatment program for insomnia during the
participants participation in the study
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- A current diagnosis of sleep-related breathing disorder, periodic limb movement
disorder, restless legs syndrome, circadian rhythm sleep disorder, or an exclusionary
score on screening instruments to rule out individuals with symptoms of certain sleep
disorders other than insomnia.
- STOPBang score greater than or equal to (>=) 5
- International Restless Legs Scale (IRLS) score >=16
- Epworth Sleepiness Scale (ESS) score >15
- Reports symptoms potentially related to narcolepsy that in the clinical opinion of the
investigator indicates the need for referral for a diagnostic evaluation for the
presence of narcolepsy
- Reports a history of sleep-related violent behavior, or sleep driving, or any other
complex sleep-related behavior, eg, making phone calls, or preparing and eating food
while asleep
- For participants who underwent polysomnography (PSG) within the previous year:
- Age 18 to 64 years: Apnea Hypopnea Index =10, or Periodic Limb Movements with
Arousal Index =10
- Age =65 years: Apnea Hypopnea Index >15, or Periodic Limb Movements with Arousal
Index >15
- Beck Depression Inventory - II (BDI II) score >19 at Screening
- Beck Anxiety Inventory (BAI) score >15 at Screening
- Habitually naps more than 3 times per week
- Females who are breastfeeding or pregnant at Screening or Study Baseline
- Females of childbearing potential who are not practicing acceptable pregnancy
prevention methods (NOTE: All females will be considered to be of childbearing
potential unless they are postmenopausal or have been sterilized surgically.)
- Excessive caffeine use that in the opinion of the investigator contributes to the
participant's insomnia, or habitually consumes caffeine-containing beverages after
18:00 and is unwilling to forego caffeine after 18:00 for the duration of his/her
participation in the study
- History of drug or alcohol dependency or abuse within approximately the previous 2
years
- Reports habitually consuming more than 14 drinks containing alcohol per week (females)
or more than 21 drinks containing alcohol per week (males), or unwilling to limit
alcohol intake to no more than 2 drinks per day or forego having alcohol within the 3
hours before bedtime for the duration of his/her participation in the study
- A prolonged QT/QT interval corrected by Fridericia's formula (QTcF >450 ms) as
demonstrated by a repeated electro cardiogram(ECG) at Screening (repeated only if
initial ECG indicates a QTcF interval >450 ms)
- Current evidence of clinically significant disease (e.g., cardiac, respiratory,
gastrointestinal, renal, neurological [including participants who lack capacity and/or
whose cognitive decline indicates disorientation to person/place/time and/or
situation], or psychiatric disease or malignancy other than basal cell carcinoma) or
chronic pain that in the opinion of the investigator(s) could affect the participant's
safety or interfere with the study assessments
- Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom
during the night
- Scheduled for major surgery during the study
- Used any prohibited prescription or over-the-counter concomitant medications within 1
week before the first dose of study medication
- Used any modality of treatment for insomnia, including cognitive behavioral therapy or
marijuana within 2 weeks before Screening
- Failed treatment with suvorexant (Belsomra®) (efficacy and/or safety) following
treatment with an appropriate dose and of adequate duration in the opinion of the
investigator
- Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or
between Screening and Study Baseline
- Previously participated in any clinical trial of lemborexant
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
15/11/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
8/01/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
971
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Indiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Massachusetts
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Missouri
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New Mexico
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New York
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
North Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Ohio
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Oklahoma
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Oregon
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Rhode Island
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Tennessee
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Texas
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Washington
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
British Columbia
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Ontario
Query!
Country [22]
0
0
Canada
Query!
State/province [22]
0
0
Quebec
Query!
Country [23]
0
0
Finland
Query!
State/province [23]
0
0
Oulun Laani
Query!
Country [24]
0
0
Finland
Query!
State/province [24]
0
0
Helsinki
Query!
Country [25]
0
0
Finland
Query!
State/province [25]
0
0
Kuopio
Query!
Country [26]
0
0
Finland
Query!
State/province [26]
0
0
Tampere
Query!
Country [27]
0
0
Finland
Query!
State/province [27]
0
0
Turku
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Nordrhein-Westfalen
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Sachsen
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Berlin
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Hamburg
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Hannover
Query!
Country [33]
0
0
Italy
Query!
State/province [33]
0
0
Lombardia
Query!
Country [34]
0
0
Italy
Query!
State/province [34]
0
0
Toscana
Query!
Country [35]
0
0
Italy
Query!
State/province [35]
0
0
Roma
Query!
Country [36]
0
0
Japan
Query!
State/province [36]
0
0
Gunma
Query!
Country [37]
0
0
Japan
Query!
State/province [37]
0
0
Hokkaido
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Kanagawa
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Saitama
Query!
Country [40]
0
0
Japan
Query!
State/province [40]
0
0
Tokyo
Query!
Country [41]
0
0
Korea, Republic of
Query!
State/province [41]
0
0
Gyeonggido
Query!
Country [42]
0
0
Korea, Republic of
Query!
State/province [42]
0
0
Daegu
Query!
Country [43]
0
0
Korea, Republic of
Query!
State/province [43]
0
0
Seoul
Query!
Country [44]
0
0
Mexico
Query!
State/province [44]
0
0
Nuevo Leon
Query!
Country [45]
0
0
New Zealand
Query!
State/province [45]
0
0
North Island
Query!
Country [46]
0
0
New Zealand
Query!
State/province [46]
0
0
South Island
Query!
Country [47]
0
0
New Zealand
Query!
State/province [47]
0
0
Auckland
Query!
Country [48]
0
0
New Zealand
Query!
State/province [48]
0
0
Rotorua
Query!
Country [49]
0
0
Poland
Query!
State/province [49]
0
0
Malopolskie
Query!
Country [50]
0
0
Poland
Query!
State/province [50]
0
0
Mazowieckie
Query!
Country [51]
0
0
Poland
Query!
State/province [51]
0
0
Gdansk
Query!
Country [52]
0
0
Poland
Query!
State/province [52]
0
0
Katowice
Query!
Country [53]
0
0
Poland
Query!
State/province [53]
0
0
Ostroda
Query!
Country [54]
0
0
Poland
Query!
State/province [54]
0
0
Warszawa
Query!
Country [55]
0
0
Romania
Query!
State/province [55]
0
0
Brasov
Query!
Country [56]
0
0
Romania
Query!
State/province [56]
0
0
Bucharest
Query!
Country [57]
0
0
Romania
Query!
State/province [57]
0
0
Constanta
Query!
Country [58]
0
0
Romania
Query!
State/province [58]
0
0
Sibiu
Query!
Country [59]
0
0
Romania
Query!
State/province [59]
0
0
Targu Mures
Query!
Country [60]
0
0
Spain
Query!
State/province [60]
0
0
Baleares
Query!
Country [61]
0
0
Spain
Query!
State/province [61]
0
0
Madrid
Query!
Country [62]
0
0
Spain
Query!
State/province [62]
0
0
Valencia
Query!
Country [63]
0
0
Spain
Query!
State/province [63]
0
0
Barcelona
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Eisai Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The key objectives of this study are to determine, using sleep diaries, whether lemborexant
at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset,
subjective sleep efficiency, and subjective sleep maintenance in participants with insomnia
disorder.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02952820
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Eisai Medical Information
Query!
Address
0
0
Eisai Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02952820
Download to PDF