Clinical Trial Results:
A Randomized, Placebo-controlled, 2-way Crossover, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of JNJ-42847922 in Subjects With Insomnia Disorder Without Psychiatric Comorbidity.
Summary
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EudraCT number |
2015-001672-22 |
Trial protocol |
DE NL |
Global end of trial date |
02 Dec 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Dec 2016
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First version publication date |
16 Dec 2016
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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 |
42847922ISM2002
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02464046 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Janssen-Cilag International NV
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Sponsor organisation address |
Turnhoutseweg 30, Beerse, Belgium, 2340
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Public contact |
Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Janssen-Cilag International NV, 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 |
02 Dec 2015
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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 |
02 Dec 2015
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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 main purpose of the study was to investigate the effect of JNJ-42847922 (change versus placebo) on sleep efficiency (SE), defined as total sleep time (TST) / time in bed (TIB), measured by polysomnography (PSG) after single and multiple dose administration to subjects with insomnia disorder without psychiatric comorbidity.
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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 and tolerability evaluations were based upon physical examinations, vital signs, electrocardiogram (ECGs), urine drug and pregnancy testing, clinical labs (hematology, chemistry panel, and urinalysis), cognitive test battery, columbia suicide severity rating scale (C-SSRS), bond and lader visual analogue scale, karolinska sleepiness scale (KSS) and adverse events (AEs) /serious adverse events (SAEs) were reported throughout the study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Aug 2015
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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 |
Germany: 15
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Country: Number of subjects enrolled |
Netherlands: 5
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Country: Number of subjects enrolled |
United States: 8
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Worldwide total number of subjects |
28
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EEA total number of subjects |
20
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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) |
28
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From 65 to 84 years |
0
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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 |
A total of 28 subjects with insomnia without psychiatric comorbidity received the study treatment, out of which 27 subjects completed the study. | |||||||||||||||
Period 1
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Period 1 title |
Crossover 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 followed by JNJ-42847922 | |||||||||||||||
Arm description |
Subjects received Placebo once daily (qd) for 5 days in treatment Period 1 followed by 40 milligram (mg) JNJ-42847922 qd for 5 days in treatment Period 2 via oral route. Both the treatment periods were separated by a washout period of minimum 5 days. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
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 |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received JNJ-42847922 matching Placebo tablets qd for 5 days via oral route.
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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 |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received 40 milligram (mg) JNJ-42847922 (2 x 20-mg tablets) qd for 5 days via oral route.
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Arm title
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JNJ-42847922 followed by Placebo | |||||||||||||||
Arm description |
Subjects received 40 mg JNJ-42847922 once daily (qd) for 5 days in treatment Period 1 followed by Placebo qd for 5 days in treatment period 2 via oral route. Both the treatment periods were separated by a washout period of minimum 5 days. | |||||||||||||||
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 |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received 40 mg JNJ-42847922 (2 x 20-mg tablets) via qd for 5 days via oral route.
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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 |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received JNJ-428479225 matching Placebo tablets qd for 5 days via oral route.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo followed by JNJ-42847922
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Reporting group description |
Subjects received Placebo once daily (qd) for 5 days in treatment Period 1 followed by 40 milligram (mg) JNJ-42847922 qd for 5 days in treatment Period 2 via oral route. Both the treatment periods were separated by a washout period of minimum 5 days. | ||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-42847922 followed by Placebo
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Reporting group description |
Subjects received 40 mg JNJ-42847922 once daily (qd) for 5 days in treatment Period 1 followed by Placebo qd for 5 days in treatment period 2 via oral route. Both the treatment periods were separated by a washout period of minimum 5 days. | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo followed by JNJ-42847922
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Reporting group description |
Subjects received Placebo once daily (qd) for 5 days in treatment Period 1 followed by 40 milligram (mg) JNJ-42847922 qd for 5 days in treatment Period 2 via oral route. Both the treatment periods were separated by a washout period of minimum 5 days. | ||
Reporting group title |
JNJ-42847922 followed by Placebo
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Reporting group description |
Subjects received 40 mg JNJ-42847922 once daily (qd) for 5 days in treatment Period 1 followed by Placebo qd for 5 days in treatment period 2 via oral route. Both the treatment periods were separated by a washout period of minimum 5 days. | ||
Subject analysis set title |
Placebo
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Intention to treat (ITT ) analysis set which included all randomized subjects who received at least one dose of the study medication (placebo or 40mg JNJ-42847922) and who had at least one Sleep Efficiency assessment.
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Subject analysis set title |
40 milligram (mg) JNJ-42847922
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
ITT analysis set which included all randomized subjects who received at least one dose of the study medication (placebo or 40mg JNJ-42847922) and who had at least one Sleep Efficiency assessment.
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Subject analysis set title |
Placebo
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects who received at least one dose of study drug were included in the safety analysis.
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Subject analysis set title |
40 mg JNJ-42847922
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects who received at least one dose of study drug were included in the safety analysis.
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End point title |
Sleep Efficiency by Polysomnography | ||||||||||||||||||
End point description |
Sleep Efficiency is defined as the total sleep time divided by the total time in bed multiplied by 100 (that is, the number of minutes from the beginning of the Polysomnography recording to the end of the recording). Sleep efficiency was evaluated using Intention to Treat (ITT) Analysis Set.
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End point type |
Primary
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End point timeframe |
Up to Night 5
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Statistical analysis title |
Statistical analysis 1 | ||||||||||||||||||
Statistical analysis description |
Statistical analysis 1 was evaluated on Day1/2.
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Comparison groups |
Placebo v 40 milligram (mg) JNJ-42847922
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Number of subjects included in analysis |
55
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||||
Method |
Mixed model repeated measures (MMRM) | ||||||||||||||||||
Parameter type |
LS Means Difference to Placebo | ||||||||||||||||||
Point estimate |
5.77
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Confidence interval |
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level |
80% | ||||||||||||||||||
sides |
2-sided
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lower limit |
3.79 | ||||||||||||||||||
upper limit |
7.74 | ||||||||||||||||||
Statistical analysis title |
Statistical analysis 2 | ||||||||||||||||||
Statistical analysis description |
Statistical analysis 2 was evaluated on day 5/6.
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Comparison groups |
40 milligram (mg) JNJ-42847922 v Placebo
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Number of subjects included in analysis |
55
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||||
Method |
Mixed model repeated measures (MMRM) | ||||||||||||||||||
Parameter type |
LS Means Difference to Placebo | ||||||||||||||||||
Point estimate |
8.12
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Confidence interval |
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level |
80% | ||||||||||||||||||
sides |
2-sided
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lower limit |
5.39 | ||||||||||||||||||
upper limit |
10.86 |
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End point title |
Total Sleep Time by Polysomnography | ||||||||||||||||||
End point description |
All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time. Sleep efficiency was evaluated using Intention to Treat Analysis Set.
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End point type |
Secondary
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End point timeframe |
Up to Night 5
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Statistical analysis title |
Statistical Analysis 1 | ||||||||||||||||||
Statistical analysis description |
Statistical Analysis 1 was evaluated on day 1/2.
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Comparison groups |
Placebo v 40 milligram (mg) JNJ-42847922
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Number of subjects included in analysis |
55
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||||
Method |
Mixed model repeated measures (MMRM) | ||||||||||||||||||
Parameter type |
LS Means Difference to Placebo | ||||||||||||||||||
Point estimate |
27.75
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Confidence interval |
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level |
80% | ||||||||||||||||||
sides |
2-sided
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lower limit |
18.28 | ||||||||||||||||||
upper limit |
37.22 | ||||||||||||||||||
Statistical analysis title |
Statistical analysis 2 | ||||||||||||||||||
Statistical analysis description |
Statistical analysis 2 was evaluated on day 5/6.
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Comparison groups |
Placebo v 40 milligram (mg) JNJ-42847922
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Number of subjects included in analysis |
55
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||||
Method |
Mixed model repeated measures (MMRM) | ||||||||||||||||||
Parameter type |
LS Means Difference to Placebo | ||||||||||||||||||
Point estimate |
39
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Confidence interval |
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level |
80% | ||||||||||||||||||
sides |
2-sided
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lower limit |
25.87 | ||||||||||||||||||
upper limit |
52.14 |
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End point title |
Wake Time After Sleep Onset by Polysomnography | ||||||||||||||||||
End point description |
The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording. The efficiency was evaluated using Intention to Treat Analysis Set. The value 999 indicates that SD was not available after back-transformation of the parameter estimates from log scale.
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End point type |
Secondary
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End point timeframe |
Up to Night 5
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Statistical analysis title |
Statistical Analysis 1 | ||||||||||||||||||
Comparison groups |
Placebo v 40 milligram (mg) JNJ-42847922
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Number of subjects included in analysis |
55
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||
P-value |
= 0.009 | ||||||||||||||||||
Method |
Mixed model repeated measures (MMRM) | ||||||||||||||||||
Parameter type |
LS Means Ratio to Placebo | ||||||||||||||||||
Point estimate |
0.72
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Confidence interval |
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level |
80% | ||||||||||||||||||
sides |
2-sided
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lower limit |
0.61 | ||||||||||||||||||
upper limit |
0.86 | ||||||||||||||||||
Statistical analysis title |
Statistical analysis 2 | ||||||||||||||||||
Comparison groups |
Placebo v 40 milligram (mg) JNJ-42847922
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Number of subjects included in analysis |
55
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||
P-value |
= 0.094 | ||||||||||||||||||
Method |
Mixed model repeated measures (MMRM) | ||||||||||||||||||
Parameter type |
LS Means Ratio to Placebo | ||||||||||||||||||
Point estimate |
0.8
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Confidence interval |
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level |
80% | ||||||||||||||||||
sides |
2-sided
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lower limit |
0.64 | ||||||||||||||||||
upper limit |
0.99 |
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End point title |
Total Time Spent in Deep Sleep by Polysomnography | ||||||||||||||||||
End point description |
Duration of slow wave sleep was reported. Sleep efficiency was evaluated using Intention to Treat Analysis Set.
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End point type |
Secondary
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End point timeframe |
Up to Night 5
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Statistical analysis title |
Statistical analysis 1 | ||||||||||||||||||
Comparison groups |
Placebo v 40 milligram (mg) JNJ-42847922
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Number of subjects included in analysis |
55
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||
P-value |
= 0.644 | ||||||||||||||||||
Method |
Mixed model repeated measures (MMRM) | ||||||||||||||||||
Parameter type |
LS Means Difference to Placebo | ||||||||||||||||||
Point estimate |
-1.96
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Confidence interval |
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level |
80% | ||||||||||||||||||
sides |
2-sided
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lower limit |
-8.84 | ||||||||||||||||||
upper limit |
4.93 | ||||||||||||||||||
Statistical analysis title |
Statistical analysis 2 | ||||||||||||||||||
Statistical analysis description |
Statistical analysis 2 was evaluated on Day 5/6.
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Comparison groups |
Placebo v 40 milligram (mg) JNJ-42847922
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Number of subjects included in analysis |
55
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||
P-value |
= 0.396 | ||||||||||||||||||
Method |
Mixed model repeated measures (MMRM) | ||||||||||||||||||
Parameter type |
LS Means Difference to Placebo | ||||||||||||||||||
Point estimate |
1.28
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Confidence interval |
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level |
80% | ||||||||||||||||||
sides |
2-sided
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lower limit |
-5.03 | ||||||||||||||||||
upper limit |
7.58 |
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End point title |
Latency to Persistent Sleep by Polysomnography | ||||||||||||||||||
End point description |
Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured over 2 nights and the average time to sleep was calculated. Sleep efficiency was evaluated using Intention to Treat Analysis Set. The value 999 indicates that SD was not available after back-transformation of the parameter estimates from log scale.
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End point type |
Secondary
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End point timeframe |
Up to Night 5
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Statistical analysis title |
Statistical analysis 1 | ||||||||||||||||||
Comparison groups |
Placebo v 40 milligram (mg) JNJ-42847922
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Number of subjects included in analysis |
55
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||||
Method |
Mixed model repeated measures (MMRM) | ||||||||||||||||||
Parameter type |
LS Means Ratio to Placebo | ||||||||||||||||||
Point estimate |
0.41
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Confidence interval |
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level |
80% | ||||||||||||||||||
sides |
2-sided
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lower limit |
0.33 | ||||||||||||||||||
upper limit |
0.5 | ||||||||||||||||||
Statistical analysis title |
Statistical analysis 2 | ||||||||||||||||||
Comparison groups |
Placebo v 40 milligram (mg) JNJ-42847922
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Number of subjects included in analysis |
55
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||||
Method |
Mixed model repeated measures (MMRM) | ||||||||||||||||||
Parameter type |
LS Means Ratio to Placebo | ||||||||||||||||||
Point estimate |
0.31
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Confidence interval |
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level |
80% | ||||||||||||||||||
sides |
2-sided
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lower limit |
0.24 | ||||||||||||||||||
upper limit |
0.4 |
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End point title |
Wake Time Within Total Sleep Period by Polysomnography | ||||||||||||||||||
End point description |
The number of minutes in the Awake stage within sleep up to the end of the recording. This endpoint was evaluated using Intention to Treat Analysis set. The value 999 indicates that SD was not available after back-transformation of the parameter estimates from log scale.
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End point type |
Secondary
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End point timeframe |
Up to Night 5
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Statistical analysis title |
Statistical analysis 1 | ||||||||||||||||||
Comparison groups |
Placebo v 40 milligram (mg) JNJ-42847922
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Number of subjects included in analysis |
55
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||
P-value |
= 0.025 | ||||||||||||||||||
Method |
Mixed model repeated measures (MMRM) | ||||||||||||||||||
Parameter type |
LS Means Ratio to Placebo | ||||||||||||||||||
Point estimate |
0.74
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Confidence interval |
|||||||||||||||||||
level |
80% | ||||||||||||||||||
sides |
2-sided
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lower limit |
0.62 | ||||||||||||||||||
upper limit |
0.9 | ||||||||||||||||||
Statistical analysis title |
Statistical analysis 2 | ||||||||||||||||||
Comparison groups |
40 milligram (mg) JNJ-42847922 v Placebo
|
||||||||||||||||||
Number of subjects included in analysis |
55
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||
P-value |
= 0.02 | ||||||||||||||||||
Method |
Mixed model repeated measures (MMRM) | ||||||||||||||||||
Parameter type |
LS Means Ratio to Placebo | ||||||||||||||||||
Point estimate |
0.7
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
80% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
0.56 | ||||||||||||||||||
upper limit |
0.87 |
|
|||||||||||||||||||
End point title |
Wake Time After Final Awakening by Polysomnography | ||||||||||||||||||
End point description |
The number of minutes of wake time after final Awakening from sleep. This endpoint was evaluated using Intention to Treat Analysis set.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Up to Night 5
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Leeds Sleep Evaluation Questionnaire (LSEQ) Score | ||||||||||||||||||||||||||||||||||||
End point description |
The LSEQ is a participant-reported 10-item visual analogue scale score used to rate the quality of sleep
and to assess changes in sleep quality over the course of treatment. This questionnaire has 10 selfrating
100 mm line analogue questions concerning sleep and early morning behavior. The higher the
score, i.e. the closer the value is to 100 the worse the rating by the participant. The 10 responses are
grouped into 4 subscores: the ease of getting to sleep, the perceived quality of sleep, the ease of
awakening from sleep and the integrity of behavior following wakefulness. Sleep efficiency was
evaluated using Intention to Treat Analysis Set.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Up to Night 5
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||
End point title |
Subjective Assessment of Sleep by Questionnaire | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Subjective assessment of sleep parameters was assessed by following questions to indicate how much
and how well participant slept during the past night: 1. How long did it take you to fall asleep for the
first time (Mean Subjective sleep onset latency); 2. How long have you slept in total (Total sleep time);
3. How long were you awake after initial sleep onset until you finally got out of bed (Wake After Sleep
Onset); 4. How often did you awake during the night (how many times); 5. How did you rate the quality
of the night sleep (1= extremely bad 10 =excellent). Sleep efficiency was evaluated using Intention to
Treat Analysis Set.
|
||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Up to Night 5
|
||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Next Morning Residual Effects by Bond and Lader Visual Analogue Scale | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The Bond and Lader Visual Analogue Scale consists of sixteen 100 mm visual analog scales anchored by
antonyms (example, Alert-Drowsy, Lethargic-Energetic, etc). Scores were combined to form three mood
factors: alertness, calmness, and contentedness. This endpoint was evaluated using Safety analysis set.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Up to Day 6
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Next Morning Residual Effects by Karolinska Sleepiness Scale | ||||||||||||||||||
End point description |
The Karolinska Sleepiness Scale is a participant-reported assessment used to rate sleepiness on a scale
of 1 to 9, ranging from 'extremely alert' (1) to 'very sleepy, great effort to keep awake, fighting sleep.
This endpoint was evaluated using Safety analysis set.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Up to Day 6
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Baseline, up to Follow-up (61 Days)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
The Adverse events were reported on Safety Analysis Set population.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received JNJ-42847922 matching Placebo tablets once daily for 5 days via oral route. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
40 mg JNJ-42847922
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received 40 milligram (mg) JNJ-42847922 (2 x 20-mg tablets) once daily for 5 days via oral route. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
03 Aug 2014 |
A combination of a hormonal contraceptive with a pearl-index less than (<) 1 percent (%) in addition to a barrier method are required for use with an investigational compound for which no reproductive toxicology studies have been completed. References to “Observed significant mean differences (active to placebo) for Sleep efficiency (SE)” have specified. To comply with German privacy regulations, no full date of birth was documented to identify a study subject. |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |