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    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
    EudraCT number
    2015-001672-22
    Trial protocol
    DE   NL  
    Global end of trial date
    02 Dec 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Dec 2016
    First version publication date
    16 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    42847922ISM2002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02464046
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, 2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    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.
    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.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Aug 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    United States: 8
    Worldwide total number of subjects
    28
    EEA total number of subjects
    20
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    28
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    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
    Period 1 title
    Crossover Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    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
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-42847922 matching Placebo tablets qd for 5 days via oral route.

    Investigational medicinal product name
    JNJ-42847922
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 40 milligram (mg) JNJ-42847922 (2 x 20-mg tablets) qd for 5 days via oral route.

    Arm title
    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
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 40 mg JNJ-42847922 (2 x 20-mg tablets) via qd for 5 days via oral route.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-428479225 matching Placebo tablets qd for 5 days via oral route.

    Number of subjects in period 1
    Placebo followed by JNJ-42847922 JNJ-42847922 followed by Placebo
    Started
    14
    14
    Completed
    13
    14
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo followed by JNJ-42847922
    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
    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.

    Reporting group values
    Placebo followed by JNJ-42847922 JNJ-42847922 followed by Placebo Total
    Number of subjects
    14 14 28
    Title for AgeCategorical
    Units: subjects
        Adults (18-64 years)
    14 14 28
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    45.5 ± 14.14 46 ± 12.37 -
    Title for Gender
    Units: subjects
        Female
    9 10 19
        Male
    5 4 9

    End points

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    End points reporting groups
    Reporting group title
    Placebo followed by JNJ-42847922
    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
    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
    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.

    Subject analysis set title
    40 milligram (mg) JNJ-42847922
    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.

    Subject analysis set title
    Placebo
    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.

    Subject analysis set title
    40 mg JNJ-42847922
    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.

    Primary: Sleep Efficiency by Polysomnography

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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.
    End point type
    Primary
    End point timeframe
    Up to Night 5
    End point values
    Placebo 40 milligram (mg) JNJ-42847922
    Number of subjects analysed
    28
    27
    Units: Percentage
    least squares mean (standard error)
        Day 1/2
    83.26 ± 1.31
    89.03 ± 1.33
        Day 5/6
    77.29 ± 1.66
    85.41 ± 1.69
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Statistical analysis 1 was evaluated on Day1/2.
    Comparison groups
    Placebo v 40 milligram (mg) JNJ-42847922
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed model repeated measures (MMRM)
    Parameter type
    LS Means Difference to Placebo
    Point estimate
    5.77
    Confidence interval
         level
    80%
         sides
    2-sided
         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.
    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
    < 0.001
    Method
    Mixed model repeated measures (MMRM)
    Parameter type
    LS Means Difference to Placebo
    Point estimate
    8.12
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    5.39
         upper limit
    10.86

    Secondary: Total Sleep Time by Polysomnography

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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.
    End point type
    Secondary
    End point timeframe
    Up to Night 5
    End point values
    Placebo 40 milligram (mg) JNJ-42847922
    Number of subjects analysed
    28
    27
    Units: minutes
    least squares mean (standard error)
        Day 1/2
    399.62 ± 6.27
    427.38 ± 6.38
        Day 5/6
    370.98 ± 7.96
    409.99 ± 8.1
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Statistical Analysis 1 was evaluated on day 1/2.
    Comparison groups
    Placebo v 40 milligram (mg) JNJ-42847922
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed model repeated measures (MMRM)
    Parameter type
    LS Means Difference to Placebo
    Point estimate
    27.75
    Confidence interval
         level
    80%
         sides
    2-sided
         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.
    Comparison groups
    Placebo v 40 milligram (mg) JNJ-42847922
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed model repeated measures (MMRM)
    Parameter type
    LS Means Difference to Placebo
    Point estimate
    39
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    25.87
         upper limit
    52.14

    Secondary: Wake Time After Sleep Onset by Polysomnography

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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.
    End point type
    Secondary
    End point timeframe
    Up to Night 5
    End point values
    Placebo 40 milligram (mg) JNJ-42847922
    Number of subjects analysed
    28
    27
    Units: minutes
    least squares mean (standard deviation)
        Day 1/2
    43.28 ± 999
    31.16 ± 999
        Day 5/6
    54.71 ± 999
    43.7 ± 999
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v 40 milligram (mg) JNJ-42847922
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.009
    Method
    Mixed model repeated measures (MMRM)
    Parameter type
    LS Means Ratio to Placebo
    Point estimate
    0.72
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    0.61
         upper limit
    0.86
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v 40 milligram (mg) JNJ-42847922
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.094
    Method
    Mixed model repeated measures (MMRM)
    Parameter type
    LS Means Ratio to Placebo
    Point estimate
    0.8
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    0.64
         upper limit
    0.99

    Secondary: Total Time Spent in Deep Sleep by Polysomnography

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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.
    End point type
    Secondary
    End point timeframe
    Up to Night 5
    End point values
    Placebo 40 milligram (mg) JNJ-42847922
    Number of subjects analysed
    28
    27
    Units: minutes (min.)
    least squares mean (standard error)
        Day 1/2
    88.52 ± 8.01
    86.56 ± 8.06
        Day 5/6
    85.77 ± 7.88
    87.04 ± 7.92
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v 40 milligram (mg) JNJ-42847922
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.644
    Method
    Mixed model repeated measures (MMRM)
    Parameter type
    LS Means Difference to Placebo
    Point estimate
    -1.96
    Confidence interval
         level
    80%
         sides
    2-sided
         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.
    Comparison groups
    Placebo v 40 milligram (mg) JNJ-42847922
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.396
    Method
    Mixed model repeated measures (MMRM)
    Parameter type
    LS Means Difference to Placebo
    Point estimate
    1.28
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -5.03
         upper limit
    7.58

    Secondary: Latency to Persistent Sleep by Polysomnography

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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.
    End point type
    Secondary
    End point timeframe
    Up to Night 5
    End point values
    Placebo 40 milligram (mg) JNJ-42847922
    Number of subjects analysed
    28
    27
    Units: minutes
    least squares mean (standard deviation)
        Day 1/2
    27.62 ± 999
    11.2 ± 999
        Day 5/6
    33.78 ± 999
    10.56 ± 999
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v 40 milligram (mg) JNJ-42847922
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed model repeated measures (MMRM)
    Parameter type
    LS Means Ratio to Placebo
    Point estimate
    0.41
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    0.33
         upper limit
    0.5
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v 40 milligram (mg) JNJ-42847922
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed model repeated measures (MMRM)
    Parameter type
    LS Means Ratio to Placebo
    Point estimate
    0.31
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    0.24
         upper limit
    0.4

    Secondary: Wake Time Within Total Sleep Period by Polysomnography

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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.
    End point type
    Secondary
    End point timeframe
    Up to Night 5
    End point values
    Placebo 40 milligram (mg) JNJ-42847922
    Number of subjects analysed
    28
    27
    Units: minutes
    arithmetic mean (standard deviation)
        Day 1/2
    34.98 ± 999
    26.02 ± 999
        Day 5/6
    35.93 ± 999
    25.18 ± 999
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v 40 milligram (mg) JNJ-42847922
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.025
    Method
    Mixed model repeated measures (MMRM)
    Parameter type
    LS Means Ratio to Placebo
    Point estimate
    0.74
    Confidence interval
         level
    80%
         sides
    2-sided
         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

    Secondary: Wake Time After Final Awakening by Polysomnography

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    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
    End point values
    Placebo 40 milligram (mg) JNJ-42847922
    Number of subjects analysed
    28
    27
    Units: minutes
    arithmetic mean (standard deviation)
        Day 1/2
    4.55 ± 8.932
    5.83 ± 14.35
        Day 5/6
    19.04 ± 30.232
    27.15 ± 42.957
    No statistical analyses for this end point

    Secondary: Leeds Sleep Evaluation Questionnaire (LSEQ) Score

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    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
    End point values
    Placebo 40 milligram (mg) JNJ-42847922
    Number of subjects analysed
    28
    27
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Day 1/2: Getting to Sleep
    46.99 ± 10.975
    37.19 ± 14.514
        Day 5/6: Getting to Sleep
    50.49 ± 10.152
    33.59 ± 13.28
        Day 1/2: Quality of Sleep
    50.2 ± 11.957
    41 ± 15.779
        Day 5/6: Quality of Sleep
    47.21 ± 11.215
    33.38 ± 18.686
        Day 1/2: Awakening from Sleep
    49.71 ± 11.406
    48.72 ± 12.558
        Day 5/6: Awakening from Sleep
    45.27 ± 8.859
    40.83 ± 18.899
        Day 1/2: Behavior Following Waking
    54.61 ± 13.363
    48.54 ± 12.045
        Day 5/6: Behavior Following Waking
    49.3 ± 14.474
    37.69 ± 17.696
    No statistical analyses for this end point

    Secondary: Subjective Assessment of Sleep by Questionnaire

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    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
    End point values
    Placebo 40 milligram (mg) JNJ-42847922
    Number of subjects analysed
    14
    14
    Units: minutes (min.)
    arithmetic mean (standard deviation)
        Day1/2: How long awake after initial sleep
    81.1 ± 76.31
    57.4 ± 42.09
        Day5/6: How long awake after initial sleep
    71.3 ± 67.63
    61.9 ± 57.06
        Day1/2: Duration Slept in Total
    340.7 ± 68.82
    361.9 ± 64.68
        Day5/6: Duration Slept in Total
    327 ± 61.96
    374.4 ± 50.96
        Day1/2: Duration took to fall asleep first time
    65.2 ± 45.06
    37.4 ± 30.8
        Day5/6: Duration took to fall asleep first time
    75.2 ± 44.44
    29.4 ± 16.93
        Day 1/2: Frequency of Wake Up During Night
    3.8 ± 2.94
    3.6 ± 2.33
        Day 5/6: Frequency of Wake Up During Night
    3.2 ± 3.18
    2.8 ± 1.88
        Day 1/2: Rate the Quality of Your Sleep
    4.6 ± 2.17
    5.9 ± 1.97
        Day 5/6: Rate the Quality of Your Sleep
    4.8 ± 1.97
    6.3 ± 2.13
    No statistical analyses for this end point

    Secondary: Next Morning Residual Effects by Bond and Lader Visual Analogue Scale

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    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
    End point values
    Placebo 40 mg JNJ-42847922
    Number of subjects analysed
    28
    27
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Day 2 Alert-Drowsy
    53.4 ± 18.88
    46 ± 17
        Day 6 Alert-Drowsy
    40.6 ± 40.6
    38.9 ± 17.78
        Day 2 Strong-Feeble
    50.4 ± 13.83
    43 ± 15
        Day 6 Strong-Feeble
    41.9 ± 13.93
    39.4 ± 16.03
        Day 2 Clearheaded-Muzzy
    51.8 ± 15.94
    52.7 ± 20.38
        Day 6 Clearheaded-Muzzy
    57.8 ± 16.45
    62.4 ± 16.2
        Day 2 Well-Coordinated-Clumsy
    48 ± 16.7
    42.2 ± 15.73
        Day 6 Well-Coordinated-Clumsy
    41 ± 14.15
    37.1 ± 18.6
        Day 2 Energetic-Lethargic
    47.1 ± 15.98
    53.5 ± 16.98
        Day 6 Energetic-Lethargic
    55.9 ± 16.64
    55.7 ± 13.27
        Day 2 Quick-Witted-Mentally Slow
    48.2 ± 12.82
    53.5 ± 15.5
        Day 6 Quick-Witted-Mentally Slow
    58 ± 12.52
    60 ± 12.16
        Day 2 Attentive-Dreamy
    52.2 ± 14.39
    45.2 ± 18.54
        Day 6 Attentive-Dreamy
    43.8 ± 19.08
    37.4 ± 17.01
        Day 2 Proficient-Incompetent
    54.9 ± 11.23
    57.9 ± 15.34
        Day 6 Proficient-Incompetent
    59.7 ± 13.9
    66.1 ± 13.52
        Day 2 Interested-Bored
    41.9 ± 15.35
    40.6 ± 18.31
        Day 6 Interested-Bored
    38.5 ± 17.36
    33.2 ± 16.49
        Day 2 Contented-Discontented
    46.9 ± 16.84
    38.2 ± 14.77
        Day 6 Contented-Discontented
    40.2 ± 16.59
    35.3 ± 17.19
        Day 2 Tranquil-Troubled
    56.5 ± 13.54
    59.3 ± 14.24
        Day 6 Tranquil-Troubled
    60.2 ± 14.97
    64.3 ± 16.46
        Day 2 Happy-Sad
    43 ± 13.51
    39.4 ± 13.62
        Day 6 Happy-Sad
    36.7 ± 17.1
    33.6 ± 15.58
        Day 2 Friendly-Antagonistic
    65.1 ± 16.52
    66.4 ± 14.34
        Day 6 Friendly-Antagonistic
    66.2 ± 16.41
    70.1 ± 15.23
        Day 2 Sociable-Withdrawn
    53.7 ± 16.71
    53.8 ± 20.17
        Day 6 Sociable-Withdrawn
    62 ± 15.93
    63.7 ± 18.4
        Day 2 Calm-Excited
    40.1 ± 16.12
    35.1 ± 14.68
        Day 6 Calm-Excited
    41.6 ± 17.22
    37.1 ± 15.43
        Day 2 Relaxed-Tense
    53.5 ± 15.25
    60.4 ± 14.76
        Day 6 Relaxed-Tense
    56.8 ± 16.43
    64.7 ± 11.46
    No statistical analyses for this end point

    Secondary: Next Morning Residual Effects by Karolinska Sleepiness Scale

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    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
    End point values
    Placebo 40 mg JNJ-42847922
    Number of subjects analysed
    28
    27
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Day 2
    5.43 ± 1.399
    4.85 ± 1.433
        Day 6
    4.71 ± 1.607
    3.89 ± 1.368
    No statistical analyses for this end point

    Adverse events

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    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.

    Serious adverse events
    Placebo 40 mg JNJ-42847922
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 27 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo 40 mg JNJ-42847922
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 28 (21.43%)
    8 / 27 (29.63%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 28 (10.71%)
    4 / 27 (14.81%)
         occurrences all number
    3
    5
    Somnolence
         subjects affected / exposed
    2 / 28 (7.14%)
    3 / 27 (11.11%)
         occurrences all number
    2
    3
    Psychiatric disorders
    Abnormal dreams
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    2
    1

    More information

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    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
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