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| ID | Type | Description | Link |
|---|---|---|---|
| 21108 | Other Identifier | Organon | |
| MK-8265-006 | Other Identifier | Merck Study Number |
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This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine)
compared to placebo in elderly participants with chronic primary
insomnia. Primary efficacy variable is Wake time After Sleep
Onset (WASO), averaged over all in-treatment time points
and measured by polysomnography (PSG).
Insomnia is a common complaint or disorder throughout the
world. About one third of the population in the industrial
countries reports difficulty initiating or maintaining sleep,
resulting in a non-refreshing or non-restorative sleep. The
majority of the insomniacs suffer chronically from their
complaints.
The maleic acid salt of Org 4420, code name Org 50081, known as Esmirtazapine, was
selected for development in the treatment of insomnia. The
first clinical trial with Esmirtazapine was a proof-of-concept trial
with a four-way cross-over design. All 3 Esmirtazapine dose
groups showed a statistically significant positive effect on
TST (objective and subjective) and WASO, as compared to
placebo.
The current study is designed to assess the efficacy and safety
of Esmirtazapine in a double-blind, placebo-controlled, parallel,
randomized trial in elderly participants suffering from chronic
primary insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esmirtazapine 0.5 mg | Experimental | one placebo tablet daily for 14 days, followed by one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days |
|
| Esmirtazapine 1.5 mg | Experimental | one placebo tablet daily for 14 days, followed by one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days |
|
| Esmirtazapine 3.0 mg | Experimental | one placebo tablet daily for 14 days, followed by one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days |
|
| Placebo | Placebo Comparator | one placebo tablet daily for 14 days, followed by one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esmirtazapine | Drug | one tablet daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Wake Time After Sleep Onset Measured by Polysomnography | Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour polysomnography (PSG) recording. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | Up to Day 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Latency to Persistent Sleep Measured by Polysomnography | Latency to Persistent Sleep (LPS) is the time from lights out to the first 20 consecutive epochs scored as sleep by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of LPS (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. |
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Inclusion Criteria:
nature of the investigation have been explained to
them, before screening evaluations;
the investigator, study staff (including raters) and the
informed consent form, and possess the ability to
respond to questions, follow instructions and complete
questionnaires;
complete the LogPad questionnaires and have
completed the questionnaires at least 6 out of 7 days of
the week preceding randomization;
occurs between 2100 hours and 2400 hours, with no more variation
from these boundaries than 2 times/ week, with 5-8.5
hours in bed;
insomnia, defined as fulfillment of the Diagnostic and Statistical Manual of Mental Disorders IV - Text Revision (DSM-IV-TR) criteria
for primary insomnia (DSM-IV-TR 307.42) with a duration
of >= 1 month; fulfill the following PSG criteria on the
two screening/baseline PSG nights:
equal to 3 h and < 7 h),
(and each night greater than or equal to 30 min),
equal to 10 min).
Exclusion Criteria:
related breathing disorders Apnea-Hypopnea Index (AHI) greater than or equal
to 15), Periodic Leg Movements with Arousals Index (PLMAI)
greater than or equal to 10), restless leg syndrome,
narcolepsy, circadian sleep wake rhythm disorders,
Rapid Eye Movement (REM) behavioral disorder or any parasomnia;
psychiatric illness causing the sleep disturbances;
depression Major Depressive Disorder (MDD) or have been diagnosed and treated
for MDD within the last 2 years;
cognitive impairment, as defined by a score of less than
26 on the Mini-Mental State Examination;
chronic pain, hepatic, renal, metabolic or cardiac
disease;
or a history of (non-febrile) seizures;
screening, as judged by the investigator;
biochemistry values at screening, as judged by the
investigator;
addiction within the last year;
stimulants, alpha-2-antagonists, respiratory stimulants and decongestants);
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Esmirtazapine 0.5 mg | One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days |
| FG001 | Esmirtazapine 1.5 mg | One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days |
| FG002 | Esmirtazapine 3.0 mg | One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days |
| FG003 | Placebo | One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Subjects Treated (AST) population consisted of participants who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Esmirtazapine 0.5 mg | One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days |
| BG001 | Esmirtazapine 1.5 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Average Wake Time After Sleep Onset Measured by Polysomnography | Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour polysomnography (PSG) recording. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | The intent to treat (ITT) population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility. | Posted | Mean | Standard Deviation | Minutes | Up to Day 16 |
|
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Participants who received at least one dose of study medication. One of the 538 enrolled participants was not treated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Esmirtazapine 0.5 mg | One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001523 | Mental Disorders |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078785 | Mirtazapine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | one tablet daily |
|
| Up to Day 16 |
| Average Total Sleep Time Measured by Polysomnography | Total sleep time (TST) is the sleep time recorded by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of TST (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | Up to Day 16 |
| Average Number of Awakenings Measured by Polysomnography | Number of awakenings (NAW) was measured by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of NAW (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | Up to Day 16 |
| Average Wake Time After Sleep Onset in the First Quarter of the Night Measured by Polysomnography | Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the first quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | Up to Day 16 |
| Average Wake Time After Sleep Onset in the Second Quarter of the Night Measured by Polysomnography | Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the second quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | Up to Day 16 |
| Average Wake Time After Sleep Onset in the Third Quarter of the Night Measured by Polysomnography | Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the third quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | Up to Day 16 |
| Average Wake Time After Sleep Onset in the Fourth Quarter of the Night Measured by Polysomnography | Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the fourth quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | Up to Day 16 |
| Average Number of Stage Shifts to Stage 1 or Wake Measured by Polysomnography | Number of stage shifts to stage 1 of sleep or to awaken was measured by PSG. A stage shift is the transition measured by PSG between various sleep stages. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of the number of stage shifts (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | Up to Day 16 |
| Average Subjective Total Sleep Time Based on Sleep Diary | Total Sleep Time (TST) is a subjective time (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period. | Up to Day 16 |
| Average Subjective Sleep Latency Based on Sleep Diary | Sleep latency (SL) is the time taken to fall asleep (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period. | Up to Day 16 |
| Average Subjective Number of Awakenings Based on Sleep Diary | Number of awakenings between sleep onset and final awakening (NAW) is a subjective number (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period. | Up to Day 16 |
| Average Subjective Wake Time After Sleep Onset Based on Sleep Diary | Wake Time after Sleep Onset (WASO) is after falling asleep initially, the subjective time that the participant was awake during the night. Daily recordings by the participant in an electronic diary (observed data only), were averaged over the entire 16-day, double-blind treatment period. | Up to Day 16 |
| Average Subjective Quality of Sleep Based on Sleep Diary | Quality of Sleep (QS) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period. | Up to Day 16 |
| Average Subjective Satisfaction of Sleep Duration Based on Sleep Diary | Satisfaction of Sleep Duration (SSD) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period. | Up to Day 16 |
| Number of Participants With an Adverse Event During the 16 Day, Double-blind Treatment Period | An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP. | Up to Day 16 |
| Number of Participants Who Discontinued Treatment Due to an Adverse Event During the 16 Day, Double-blind Treatment Period | An AE is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP. | Up to Day 16 |
| Withdrawal by Subject |
|
| Reasons not related to trial |
|
| Other (reason not specified) |
|
| Adverse Event |
|
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
| BG002 | Esmirtazapine 3.0 mg | One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days |
| BG003 | Placebo | One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
| OG001 | Esmirtazapine 1.5 mg | One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days |
| OG002 | Esmirtazapine 3.0 mg | One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days |
| OG003 | Placebo | One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days |
|
|
|
| Secondary | Average Latency to Persistent Sleep Measured by Polysomnography | Latency to Persistent Sleep (LPS) is the time from lights out to the first 20 consecutive epochs scored as sleep by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of LPS (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility. | Posted | Mean | Standard Deviation | Minutes | Up to Day 16 |
|
|
|
|
| Secondary | Average Total Sleep Time Measured by Polysomnography | Total sleep time (TST) is the sleep time recorded by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of TST (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility. | Posted | Mean | Standard Deviation | Minutes | Up to Day 16 |
|
|
|
|
| Secondary | Average Number of Awakenings Measured by Polysomnography | Number of awakenings (NAW) was measured by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of NAW (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility. | Posted | Mean | Standard Deviation | Number of awakenings | Up to Day 16 |
|
|
|
|
| Secondary | Average Wake Time After Sleep Onset in the First Quarter of the Night Measured by Polysomnography | Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the first quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility. | Posted | Mean | Standard Deviation | Minutes | Up to Day 16 |
|
|
|
|
| Secondary | Average Wake Time After Sleep Onset in the Second Quarter of the Night Measured by Polysomnography | Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the second quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility. | Posted | Mean | Standard Deviation | Minutes | Up to Day 16 |
|
|
|
|
| Secondary | Average Wake Time After Sleep Onset in the Third Quarter of the Night Measured by Polysomnography | Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the third quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility. | Posted | Mean | Standard Deviation | Minutes | Up to Day 16 |
|
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|
|
| Secondary | Average Wake Time After Sleep Onset in the Fourth Quarter of the Night Measured by Polysomnography | Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the fourth quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility. | Posted | Mean | Standard Deviation | Minutes | Up to Day 16 |
|
|
|
|
| Secondary | Average Number of Stage Shifts to Stage 1 or Wake Measured by Polysomnography | Number of stage shifts to stage 1 of sleep or to awaken was measured by PSG. A stage shift is the transition measured by PSG between various sleep stages. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of the number of stage shifts (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged. | The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility. | Posted | Mean | Standard Deviation | Number of stage shifts | Up to Day 16 |
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| Secondary | Average Subjective Total Sleep Time Based on Sleep Diary | Total Sleep Time (TST) is a subjective time (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period. | The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility. | Posted | Mean | Standard Deviation | Minutes | Up to Day 16 |
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|
| Secondary | Average Subjective Sleep Latency Based on Sleep Diary | Sleep latency (SL) is the time taken to fall asleep (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period. | The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility. | Posted | Mean | Standard Deviation | Minutes | Up to Day 16 |
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| Secondary | Average Subjective Number of Awakenings Based on Sleep Diary | Number of awakenings between sleep onset and final awakening (NAW) is a subjective number (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period. | The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility. | Posted | Mean | Standard Deviation | Number of Awakenings | Up to Day 16 |
|
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|
|
| Secondary | Average Subjective Wake Time After Sleep Onset Based on Sleep Diary | Wake Time after Sleep Onset (WASO) is after falling asleep initially, the subjective time that the participant was awake during the night. Daily recordings by the participant in an electronic diary (observed data only), were averaged over the entire 16-day, double-blind treatment period. | The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility. | Posted | Mean | Standard Deviation | Minutes | Up to Day 16 |
|
|
|
|
| Secondary | Average Subjective Quality of Sleep Based on Sleep Diary | Quality of Sleep (QS) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period. | The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility. | Posted | Mean | Standard Deviation | Units on a Scale | Up to Day 16 |
|
|
|
|
| Secondary | Average Subjective Satisfaction of Sleep Duration Based on Sleep Diary | Satisfaction of Sleep Duration (SSD) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period. | The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility. | Posted | Mean | Standard Deviation | Units on a Scale | Up to Day 16 |
|
|
|
|
| Secondary | Number of Participants With an Adverse Event During the 16 Day, Double-blind Treatment Period | An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP. | All participants who received at least one dose of study medication. | Posted | Number | Number of participants | Up to Day 16 |
|
|
|
| Secondary | Number of Participants Who Discontinued Treatment Due to an Adverse Event During the 16 Day, Double-blind Treatment Period | An AE is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP. | All participants who received at least one dose of study medication. | Posted | Number | Number of participants | Up to Day 16 |
|
|
|
| 0 |
| 132 |
| 18 |
| 132 |
| EG001 | Esmirtazapine 1.5 mg | One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days | 0 | 136 | 21 | 136 |
| EG002 | Esmirtazapine 3.0 mg | One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days | 0 | 133 | 27 | 133 |
| EG003 | Placebo | One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days | 0 | 136 | 8 | 136 |
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |
| 0.0234 |
Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate |
| Superiority or Other |
| ANCOVA | 0.0102 | Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate | Superiority or Other |
| <0.0001 |
Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate |
| Superiority or Other |
| ANCOVA | <0.0001 | Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate | Superiority or Other |
| 0.0213 |
Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate |
| Superiority or Other |
| ANCOVA | 0.0135 | Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate | Superiority or Other |
| 0.0003 |
Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate |
| Superiority or Other |
| ANCOVA | <0.0001 | Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate | Superiority or Other |
| <0.0001 |
Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate |
| Superiority or Other |
| ANCOVA | <0.0001 | Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate | Superiority or Other |
| <0.0001 |
Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate |
| Superiority or Other |
| ANCOVA | <0.0001 | Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate | Superiority or Other |
| <0.0001 |
Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate |
| Superiority or Other |
| ANCOVA | <0.0001 | Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate | Superiority or Other |
| <0.0001 |
Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate |
| Superiority or Other |
| ANCOVA | <0.0001 | Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate | Superiority or Other |
| <0.0001 |
Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate |
| Superiority or Other |
| ANCOVA | <0.0001 | Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate | Superiority or Other |
| 0.6355 |
Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate |
| Superiority or Other |
| ANCOVA | 0.7865 | Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate | Superiority or Other |
| 0.4153 |
Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate |
| Superiority or Other |
| ANCOVA | 0.6271 | Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate | Superiority or Other |
| <0.0001 |
Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate |
| Superiority or Other |
| ANCOVA | <0.0001 | Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate | Superiority or Other |
| 0.0242 |
Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate |
| Superiority or Other |
| ANCOVA | 0.0007 | Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate | Superiority or Other |
| 0.0316 |
Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate |
| Superiority or Other |
| ANCOVA | 0.0014 | Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate | Superiority or Other |