Clinical Trial Results:
A Multicenter, Double-Blind, Randomized, Parallel-Group, Active- and Placebo-Controlled Polysomnography Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Subjects With Insomnia Disorder
Summary
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EudraCT number |
2017-000980-33 |
Trial protocol |
DE BE PL FR |
Global end of trial date |
03 Apr 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Apr 2020
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First version publication date |
16 Apr 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
42847922ISM2005
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03375203 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Janssen Research & Development, LLC
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Sponsor organisation address |
Turnhoutseweg 30, Beerse, Belgium, B-2340
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Public contact |
Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
03 Apr 2019
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Apr 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study was to assess the dose-response of 3 doses of seltorexant (5 milligram [mg], 10 mg, and 20 mg) compared to placebo on an objective measure of sleep onset in subjects with insomnia disorder.
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Protection of trial subjects |
This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety evaluations were based on adverse events, clinical laboratory tests (hematology, serum chemistry, and urinalysis), vital sign measurements, physical examinations, electrocardiogram (ECG), Cognitive assessment (modified Patient Reported Outcome Measurement Information System-Applied Cognition Abilities [PROMIS-ACA] and cognitive functioning evaluations), residual effects (Karolinska Sleepiness Scale [KSS], body sway), withdrawal effects (Physician Withdrawal Checklist [PWC], Benzodiazepine Withdrawal Symptom Questionnaire [BWSQ]), Columbia Suicide Severity Rating Scale (C-SSRS).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 Nov 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 285
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Country: Number of subjects enrolled |
Belgium: 9
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Country: Number of subjects enrolled |
France: 1
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Country: Number of subjects enrolled |
Germany: 43
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Country: Number of subjects enrolled |
Japan: 21
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Country: Number of subjects enrolled |
Poland: 5
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Worldwide total number of subjects |
364
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EEA total number of subjects |
58
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
238
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From 65 to 84 years |
126
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Total of 365 subjects were randomized, 364 were treated. 1 subject was randomized in error group never received study drug, was discontinued from study. 1 subject was randomized to JNJ-42847922 10 mg group received 5 mg of JNJ-42847922 and was summarized under 5 mg group for safety analyses, and under 10 mg dose group for all other analyses. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
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Arm title
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JNJ-42847922 5 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects received JNJ-42847922 5 milligram (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
JNJ-42847922
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received JNJ-42847922 5 milligram (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
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Arm title
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JNJ-42847922 10 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects receive JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
JNJ-42847922
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects receive JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo oral capsule for 14 consecutive nights from Day 1 to Day 14.
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Arm title
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JNJ-42847922 20 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
JNJ-42847922
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo oral capsule for 14 consecutive nights from Day 1 to Day 14.
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Arm title
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Zolpidem | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Zolpidem
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received Zolpidem 5 mg as one 5 mg capsule and one placebo oral capsule, or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-42847922 5 mg
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Reporting group description |
Subjects received JNJ-42847922 5 milligram (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-42847922 10 mg
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Reporting group description |
Subjects receive JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-42847922 20 mg
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Reporting group description |
Subjects received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Zolpidem
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Reporting group description |
Subjects received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14. | ||
Reporting group title |
JNJ-42847922 5 mg
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Reporting group description |
Subjects received JNJ-42847922 5 milligram (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14. | ||
Reporting group title |
JNJ-42847922 10 mg
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Reporting group description |
Subjects receive JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14. | ||
Reporting group title |
JNJ-42847922 20 mg
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Reporting group description |
Subjects received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14. | ||
Reporting group title |
Zolpidem
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Reporting group description |
Subjects received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14. | ||
Subject analysis set title |
Placebo
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Subjects received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
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Subject analysis set title |
JNJ-42847922 5 mg
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Subjects received JNJ-42847922 5 milligram (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject is summarized under the 5 mg dose group for safety analyses.
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Subject analysis set title |
JNJ-42847922 10 mg
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Subjects receive JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject is summarized under the 5 mg dose group for safety analyses.
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Subject analysis set title |
JNJ-42847922 20 mg
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Subjects received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
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Subject analysis set title |
Zolpidem
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Subjects received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
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End point title |
Change from Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | ||||||||||||||||||||||||
End point description |
LPS was measured on Night 1 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch scored as sleep. The LPS change from baseline on Night 1 was calculated as (LPS at Night 1 minus Baseline LPS). Negative changes in LPS indicated improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
Baseline and Night 1
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Statistical analysis title |
Stastistical Analysis 1 | ||||||||||||||||||||||||
Comparison groups |
JNJ-42847922 5 mg v Placebo
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Number of subjects included in analysis |
146
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||||||||||
P-value |
= 0.346 | ||||||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||||||
Parameter type |
Back-transformed Least Square Mean Ratio | ||||||||||||||||||||||||
Point estimate |
0.88
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Confidence interval |
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level |
90% | ||||||||||||||||||||||||
sides |
2-sided
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lower limit |
0.7 | ||||||||||||||||||||||||
upper limit |
1.1 | ||||||||||||||||||||||||
Statistical analysis title |
Stastistical Analysis 2 | ||||||||||||||||||||||||
Comparison groups |
Placebo v JNJ-42847922 10 mg
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Number of subjects included in analysis |
148
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||||||||||
P-value |
= 0.001 | ||||||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||||||
Parameter type |
Back-transformed Least Square Mean Ratio | ||||||||||||||||||||||||
Point estimate |
0.64
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Confidence interval |
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level |
90% | ||||||||||||||||||||||||
sides |
2-sided
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lower limit |
0.51 | ||||||||||||||||||||||||
upper limit |
0.81 | ||||||||||||||||||||||||
Statistical analysis title |
Stastistical Analysis 3 | ||||||||||||||||||||||||
Comparison groups |
Placebo v JNJ-42847922 20 mg
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Number of subjects included in analysis |
146
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||||||
Parameter type |
Back-transformed Least Square Mean Ratio | ||||||||||||||||||||||||
Point estimate |
0.51
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Confidence interval |
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level |
90% | ||||||||||||||||||||||||
sides |
2-sided
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lower limit |
0.41 | ||||||||||||||||||||||||
upper limit |
0.64 |
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End point title |
Change from Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 | ||||||||||||||||||||||||
End point description |
Polysomnography was used to measure the time to wake after initial sleep onset over the first 6 hours (WASO-6) on Night 1 was reported. Negative changes in WASO-6 indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline and Night 1
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No statistical analyses for this end point |
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End point title |
Change from Baseline in Latency to Persistent Sleep as Measured by PSG on Night 13 | ||||||||||||||||||||||||
End point description |
LPS was measured on Night 13 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch scored as sleep. Negative changes in LPS indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline and Night 13
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No statistical analyses for this end point |
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End point title |
Change from Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13 | ||||||||||||||||||||||||
End point description |
Polysomnography was used to measure the time to wake after initial sleep onset over the first 6 hours (WASO-6) on Night 13 was reported. Negative changes in WASO-6 indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline and Night 13
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No statistical analyses for this end point |
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End point title |
Change from Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 | ||||||||||||||||||||||||||||||||||||
End point description |
TST is defined as the total sleep time in minutes, the total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Nights 1 and 13
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 | ||||||||||||||||||||||||||||||||||||
End point description |
TST is defined as the total sleep time in minutes, the total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Nights 1 and 13
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | ||||||||||||||||||||||||||||||||||||
End point description |
Sleep efficiency was measured as the total sleep time divided by the total time in bed (that is, the number of hours from the beginning of the Polysomnography recording to the end of the recording) (in percent). Positive changes in SE indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Nights 1 and 13
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Wake After Sleep Onset Total Score Measured Hourly on Day 1 and 13 from Hour 1 to Hour 8 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Polysomnography was used to measure the time to wake after initial sleep onset measured hourly on Day 1 and 13 from Hour 1 to Hour 8 was reported. WASO is measured during overnight sleep laboratory (PSG) assessment and defined as the duration of wakefulness from the onset of persistent sleep (that is, 10 consecutive minutes of sleep) over 8 hours of PSG assessment. Negative changes in WASO indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Day 1 and 13
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Number of Nighttime Awakenings (nNAW) Over 6 Hours on Day 1 and 13 | ||||||||||||||||||||||||||||||||||||
End point description |
PSG was used to measure the number of nighttime awakening over the first 6 hours after initial sleep onset. Negative changes in nNAW indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Day 1 and 13
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Wake During Total Sleep Period on Day 1 and 13 | ||||||||||||||||||||||||||||||||||||
End point description |
PSG was used to measure wake time during the total recording period. Negative changes in wake during total sleep period indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Day 1 and 13
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Wake After Final Awakening on Day 1 and 13 | ||||||||||||||||||||||||||||||||||||
End point description |
Polysomnography was used to measure the time awake after final awakening to the end of the PSG period. Negative changes in wake after final awakening indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Day 1 and 13
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Number of Nighttime Awakenings per hour (nNAW/hr) on Day 1 and 13 | ||||||||||||||||||||||||||||||||||||
End point description |
PSG was used to measure number of nighttime awakenings per hour. Negative changes in nNAW/hr indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Day 1 and 13
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Time to First Awakening After Sleep on Day 1 and 13 | ||||||||||||||||||||||||||||||||||||
End point description |
PSG was used to measure the time to first awakening after sleep onset. Positive changes in time to first awakening after sleep indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Day 1 and 13
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Rapid Eye Movement (REM) duration on Day 1 and 13 | ||||||||||||||||||||||||||||||||||||
End point description |
PSG was used to measure REM duration (time to first REM period from sleep onset). FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Day 1 and 13
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Rapid Eye Movement Latency on Day 1 and 13 | ||||||||||||||||||||||||||||||||||||
End point description |
PSG was used to measure the REM latency. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Day 1 and 13
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects with Sleep-Onset Rapid Eye Movement on Day 1 and 13 | ||||||||||||||||||||||||||||||||||||
End point description |
PSG was used to measure the sleep-onset REM in subjects. REM sleep periods within 15 minutes from sleep onset were measured. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 1 and 13
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Number of Sleep Cycles on Day 1 and 13 | ||||||||||||||||||||||||||||||||||||
End point description |
PSG was used to measure the number of sleep cycles. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Day 1 and 13
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep Stages N1, N2 and N3 on Day 1 and 13 | ||||||||||||||||||||||||||||||||||||
End point description |
PSG was used to measure total time spent in non-rapid eye movement sleep stages N1, N2 and N3. Positive changes in NREM (total of N1-N3) duration indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Day 1 and 13
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
CSD-M is a standardized subject diary based on expert consensus and qualitative subject input to retrieve patient reported subjective sleep parameters related to prior night's sleep. It allows for calculation of total time spent in bed and SE (as % of time asleep out of amount of time spent in bed). Sleep quality and how well rested subject felt at awaking are rated on a 5-point Likert scale ranges from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. CSD-M parameters analyzed includes: sSOL, sTST, sWASO. Negative change in sSOL, sWASO indicate improvement. Positive change in sTST indicates improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint and 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Days 2 and 14
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The CSD-M is a standardized subject diary based on expert consensus and qualitative subject input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. It allows for calculation of total time spent in bed and SE (as the percentage of time asleep out of amount of time spent in bed). Sleep quality and how well rested subjects felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. CSD-M parameters analyzed includes: sFRESH and sQUAL. Positive change in sFRESH and sQUAL indicates improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
|
||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Day 2 and 14
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW) | ||||||||||||||||||||||||||||||||||||
End point description |
CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. It allows for calculation of total time spent in bed and SE (as the percentage of time asleep out of amount of time spent in bed). Sleep quality and how well rested participants felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. CSD-M parameters analyzed include: s-nNAW. Negative change in s-nNAW indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Day 2 and 14
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System – Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14 | ||||||||||||||||||||||||||||||||||||
End point description |
PROMIS Sleep Disturbance (PROMIS-SD) Short Form subscale consists of a static 8-item questionnaire. Using a recall period of the past 7 days, it assesses the concepts of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items) and worrying about sleep (1 item). Each question has 5 response options ranging in value from 1-5. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For the 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. Lower scores indicate less sleep disturbance. Negative changes in scores indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Days 8 and 14
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System – Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14 | ||||||||||||||||||||||||||||||||||||
End point description |
PROMIS for Sleep Related Impairment (PROMIS-SRI) scale consists of 8 items to evaluated daytime consequences on functioning on 5-point Likert scales. PROMIS-SRI measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Each question has five response options ranging in value from 1-5. To find total raw score for a short form with all questions answered, sum values of response to each question. For 8-item form, lowest possible raw score is 8; highest possible raw score is 40. Higher score indicates greater sleep impairment. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Days 8 and 14
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Change from Baseline in Subjects's Assessment of Insomnia Severity Using the Patient Global Impression - Severity (PGI-S) Scale on Day 14 | ||||||||||||||||||||||||
End point description |
The PGI-S is a self-report scale to measure severity of illness (1=no insomnia, 2=very mild, 3=mild, 4=moderate, 5=severe, 6=very severe). Considering all aspects of insomnia, subjects were rated their severity on the PGI-S scale. Negative changes in scores indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Baseline and Day 14
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Change from Baseline in Subject's Assessment of Improvement in Insomnia Using the Patient Global Impression - Improvement (PGI-I) Scale on Day 14 | ||||||||||||||||||||||||
End point description |
PGI-I is a self-report scale to measure improvement in illness (1=very much improved, 2=much improved, 3=improved [just enough to make a difference], 4=no change, 5=worse [just enough to make a difference], 6=much worse, 7=very much worse). Negative changes in scores indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Baseline and Day 14
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of Subjects Who Achieved Response During on Insomnia Severity Index (ISI) Total Score on Day 14 | ||||||||||||||||||||||||
End point description |
Percentage (%) of Responders defined as at least 50% reduction from baseline in ISI total score were reported. It is a 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems; distress caused by sleep difficulties. 5-point Likert scale (0-4) was used to rate each item, total score ranges from 0-28. Negative changes in scores indicate improvement. Total score interpreted insomnia as follows: absence (0-7); sub-threshold (8-14); moderate (15-21); severe (22-28). FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Subjects with missing values at a given time point are imputed as non-responders for that time point.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Day 14
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of Subjects Who Achieved Response During on Insomnia Severity Index (ISI) Total Score on Day 14 – Observed Case | ||||||||||||||||||||||||
End point description |
% of Responders defined as at least 50% reduction from baseline in ISI total score were reported. It is a 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems; distress caused by sleep difficulties. 5-point Likert scale (0-4) was used to rate each item, total score ranges from 0-28. Negative changes in scores indicate improvement. Total score interpreted insomnia as follows: absence (0-7); sub-threshold (8-14); moderate (15-21); severe (22-28). FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number subjects evaluable for this endpoint. Subjects with missing values at a given time point are excluded from frequency calculation for that time point.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Day 14
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of Subjects Who Achieved Remission During on Insomnia Severity Index (ISI) Total Score on Day 14 | ||||||||||||||||||||||||
End point description |
Percentage of subjects with remission of insomnia symptom defined as, total score of less than or equal to (<=) 10 on ISI scale. ISI is a 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; distress caused by sleep difficulties. A 5-point Likert scale (0-4) is used to rate each item, yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). Negative changes in scores indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Subjects with missing values at a given time point are imputed as non-remitters for that time point.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Day 14
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of Subjects Who Achieved Remission During on Insomnia Severity Index (ISI) Total Score on Day 14 – Observed Case | ||||||||||||||||||||||||
End point description |
% of subjects with remission of insomnia symptom defined as, total score of <= 10 on ISI scale. ISI is 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; distress caused by sleep difficulties. 5-point Likert scale (0-4) is used to rate each item, total score ranging from 0-28 and interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); severe insomnia (22-28). FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Subjects with missing values at a given time point are excluded from the frequency calculation for that time point.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Day 14
|
||||||||||||||||||||||||
|
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No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Clinician's Assessment of Insomnia Severity Using the Clinical Global Impression - Severity (CGI-S) Total Score on Day 14 | ||||||||||||||||||||||||||||||||||||
End point description |
The CGI-S is a 7-point scale to measure severity of illness (1=normal [not at all ill], 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients). Higher score indicates more severity. Negative changes in scores indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline and Day 14
|
||||||||||||||||||||||||||||||||||||
|
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No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in in Clinician's Assessment of Insomnia Improvement Using Clinical Global Impression-Improvement (CGI-I) Total Score on Day 14 | ||||||||||||||||||||||||||||||||||||
End point description |
The CGI-I is a 7-point scale to measure improvement in illness (1=very much improved, 2=much improved, 3=minimally improved, 4=no change from baseline, 5=minimally worse, 6=much worse, 7=very much worse). Higher score indicates more severity. Negative changes in scores indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline and Day 14
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of Subjects with Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | ||||||||||||||||||
End point description |
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE defined as the number of subjects who experience at least 1 occurrence of the given event summarized by system organ class, preferred term, and treatment group. Safety analysis set (SAS) included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Up to Day 17
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Number of Subjects with Treatment-Emergent Serious Adverse Events and Events of Special Interest | ||||||||||||||||||||||||||||||
End point description |
TEAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly, is a suspected transmission of any infectious agent via a medicinal product and events of special interest include: Cataplexy; Sleep paralysis; Complex sleep-related behaviors such as confusional arousals, somnambulism (sleep walking), sleep terrors, bruxism (teeth grinding), sleep sex, sleep related eating disorder, sleep behavior disorder, and catathrenia (REM-associated end-inspiratory apnea/breath holding); Abnormal dreams; Falls. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Up to Day 17
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of Subjects With Clinically Significant Vital Signs and Physical Abnormalities | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Abnormally low parameters include pulse (bpm)- Decrease value from baseline greater than or equal to (>=) 15 to <=50; Systolic BP (mmHg [Millimetre of mercury])- Decrease value from baseline >=20 to <=90; Diastolic BP- decrease value from baseline >=15 to <=50; weight (Kilogram[Kg])- Decrease from baseline >=7%; Body temperature (Celsius [C])- <35.5; Abnormally high parameters include pulse- increase value from baseline >=15 to >=100; Systolic BP(mmHg)- Increase from baseline of >=20 to >=180; Diastolic BP- increase value from baseline>=15 to >=105; weight(Kg)- increase from baseline of >=7%; body temperature (C)- >37.5. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Up to Day 15
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of Subjects With Clinically Significant Electrocardiogram (ECG) Abnormalities | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Twelve-lead ECGs was recorded in a supine position and different ECG intervals (RR, PR, QRS, and QT) and heart rate was measured. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points. Here, bpm indicates beats per minute. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Up to Day 14
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of Subjects With Clinically Significant Laboratory Abnormalities | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Number of subjects with clinically significant laboratory abnormalities was assessed. Blood samples for serum chemistry (albumin, alkaline phosphatase etc), hematology (hemoglobin, hematocrit, etc), and urinalysis (pH, specific gravity, etc) was collected for clinical laboratory testing. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses. Here, Abn., ALT , AST, GGT signifies abnormally, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase respectively.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Up to Day 15
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of Subjects with Suicidal Ideation as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
C-SSRS is a questionnaire designed to solicit occurrence, severity, frequency of suicidal ideation/behaviors using following scores: Suicidal Ideation (1:Wish to be Dead; 2:Non-specific Active Suicidal Thoughts; 3:Active Suicidal Ideation with Any Methods without Intent to Act; 4:Active Suicidal Ideation with Some Intent to Act; 5:Active Suicidal Ideation with Specific Plan/Intent). Suicidal Behavior (6:Preparatory Acts; 7:Aborted Attempt; 8:Interrupted Attempt; 9:Actual Attempt; 10:Completed Suicide). If no events qualify for score of 1-10, score 0 indicate “no event that can be assessed on basis of C-SSRS”. Higher scores= greater severity. SAS included all subjects who were randomly assigned to drug and received at least 1 dose of drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. 1 subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922 and was summarized under 5 mg dose group for safety analyses.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 14
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14 | ||||||||||||||||||||||||||||||||||||
End point description |
The KSS is a patient reported assessment of level of drowsiness at the time of scale administration. This scale is focused mainly on the propensity to fall asleep and has a high validity in measuring sleepiness. It consists of a 9-point Likert scale with response options from: 1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep). SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Days 2 and 14
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Next-Day Residual Effects Measured by Postural Stability (Body Sway) | ||||||||||||||||||||||||
End point description |
The body sway meter allows measurement of body movements in a single plane, providing a measure of postural stability. Body sway is measured using an ataxiameter. Subjects were instructed to wear a pair of thin socks for each session. Before starting a measurement, subjects were asked to stand still and comfortable, with their feet approximately 10 centimeters (cm) apart and their hands in a relaxed position alongside the body and eyes closed. The total period of body sway measurement was 2 minutes. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Day 14 (morning)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Change From Baseline in Power of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | ||||||||||||||||||||||||
End point description |
Power of Attention is a combination of the speed scores from the three tests of attention, and is established to reflect the ability to focus attention and to process information. Larger scores reflect poorer ability. The sum of the reaction time measures from the attentional tasks (Simple Reaction Time, Choice Reaction Time and Digit Vigilance Speed). SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Baseline and Day 14 (Morning)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Change From Baseline in Continuity of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | ||||||||||||||||||||||||
End point description |
Continuity of Attention is a combination of the speed scores from the Choice Reaction Time and Digit Vigilance tasks and reflects the ability to sustain attention over time. Smaller scores indicate poorer ability. The sum of the accuracy measures from the attentional tasks (Choice Reaction Time and Digit Vigilance Accuracy) minus Digit Vigilance False Alarms (errors). SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Baseline and Day 14 (Morning)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Change From Baseline in Quality of Working Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | ||||||||||||||||||||||||
End point description |
Quality of working memory is a combination of the scores from Spatial Working Memory and Numeric Working Memory tasks, and is established to reflect the ability to temporarily hold numeric and spatial information in memory. Smaller scores reflect poorer ability. The sum of Spatial and Numeric Working Memory sensitivity indices (accuracy). SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Baseline and Day 14 (Morning)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Change From Baseline in Quality of Episodic Secondary Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | ||||||||||||||||||||||||
End point description |
Quality of Episodic Secondary Memory is a combination of accuracy measures from Word Recognition, Immediate Word Recall and Delayed Word Recall tasks and reflects the ability to store and retrieve information in episodic memory. Smaller scores reflect poorer ability. The sum of accuracy measures from the Immediate and Delayed Word Recall tasks, adjusted for errors, and from the word and picture recognition tasks. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject is summarized under the 5 mg dose group.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Baseline and Day 14 (Morning)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Change From Baseline in Speed of Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | ||||||||||||||||||||||||
End point description |
The sum of the speed measures from the two working memory tasks (Spatial and Numeric) and the two recognition tasks (Word and Picture). Speed of Memory combines reaction times from Spatial Working Memory, Numeric Working Memory, Word Recognition and Picture recognition tasks. This score measures memory retrieval speed. Larger scores reflect poorer ability. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Baseline and Day 14 (Morning)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||
End point title |
Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary–Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), sTST | ||||||||||||||||||||||||||||||||||||||||||
End point description |
CSD-M is a standardized subject diary based on expert consensus and qualitative subject input to retrieve patient reported subjective sleep parameters related to prior night's sleep. It allows for calculation of total time spent in bed and SE as percentage of time asleep out of amount of time spent in bed. Sleep quality and how well rested subjects felt at awaking are rated on a 5-point Likert scale ranging from 0 (very poor) to 4 (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. Negative change in sSOL, sWASO indicate improvement and positive change in Subjective Total Sleep Time (sTST) indicates improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
|
||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 14 to Day 17
|
||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary–Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | ||||||||||||||||||||||||||||||||||||
End point description |
CSD-M is a standardized subject diary based on expert consensus and qualitative subject input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. It allows for calculation of total time spent in bed and SE as the percentage of time asleep out of amount of time spent in bed. Sleep quality and how well rested subjects felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. CSD-M parameters analyzed includes: sFRESH and sQUAL. Positive change in sFRESH and sQUAL indicates improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 14 to 17
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary–Morning Administration (CSD-M): Number of Nighttime Awakenings (s-nNAW) | ||||||||||||||||||||||||
End point description |
CSD-M is a standardized subject diary based on expert consensus and qualitative subject input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. It allows for calculation of total time spent in bed and SE (as the percentage of time asleep out of amount of time spent in bed). Sleep quality and how well rested subjects felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. CSD-M parameters analyzed includes: s-nNAW. Negative change in s-nNAW indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Day 14 to 17
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No statistical analyses for this end point |
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End point title |
Number of Subjects Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
PWC-20 is a reliable, sensitive instrument used to assess potential withdrawal symptoms following cessation of treatment. Items are as follows: Loss of Appetite, Nausea-Vomiting, Diarrhea, Anxiety-Nervousness, Irritability, Dysphoric Mood-Depression, Insomnia, Fatigue, Poor Coordination, Restlessness, Diaphoresis, Tremor, Dizziness, Headaches, Stiffness, Weakness, Increased Acuity Sound Smell Touch (IASST), Paresthesias, Remember, Derealization. Each item score ranges from 0 (not present)-3 (severe), where higher scores = more affected condition. Total score ranges from 0-60 where higher score indicates more affected condition. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. 1 subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922 and was summarized under 5 mg dose group for safety analyses.
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End point type |
Secondary
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End point timeframe |
Day 14 to 17
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No statistical analyses for this end point |
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End point title |
Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score for Self-Assessment of Withdrawal Symptoms on Day 17 | ||||||||||||||||||||||||
End point description |
The BWSQ is a 20 symptom self-report questionnaire to investigate withdrawal symptoms. Total scores can range from 0-40 with higher scores indicating greater severity of symptoms. Subjects rate the degree to which they are experiencing each symptom as either "No," "Yes-moderate" or "Yes-severe". The questionnaire has been shown to be reliable and to have acceptable construct validity in assessing withdrawal symptoms. Total scores can range from 0-40 with higher scores indicating greater severity of symptoms. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
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End point type |
Secondary
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End point timeframe |
Day 17
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Up to Day 17
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Adverse event reporting additional description |
Safety analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21.1
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Reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-42847922 5 mg
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Reporting group description |
Subjects received JNJ-42847922 5 milligram (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-42847922 10 mg
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Reporting group description |
Subjects receive JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-42847922 20 mg
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Reporting group description |
Subjects received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Zolpidem
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Reporting group description |
Subjects received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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22 Jan 2018 |
The overall reason for the amendment is to update exclusion criteria, based on Health Authority request to ensure breastfeeding women are excluded from the study and to provide more detail on certain clinical conditions that are contra-indicated for zolpidem use. |
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24 Apr 2018 |
To add results of the male and female rat fertility studies; To exclude further enrollment of women of childbearing potential (WOCBP); In addition, other minor changes and clarifications related to study procedures were made. |
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25 Jul 2018 |
To remove the interim analysis from the protocol; To change a secondary objective to an exploratory objective; To change an exploratory correlation analysis; To clarify the inclusion criteria regarding the follicle stimulating hormone (FSH) level threshold for postmenopausal women and the time spent in bed as well as the exclusion criterion for the threshold of ECG abnormalities; To add abnormal (vivid) dreams as an adverse event of special interest; In addition, other minor changes and clarifications related to study procedures were made. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |