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    Clinical Trial Results:
    A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP 110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Obstructive Sleep Apnea (OSA)

    Summary
    EudraCT number
    		 2014-005514-31
    Trial protocol
    		 DE   NL  
    Global end of trial date
    23 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jan 2018
    First version publication date
    07 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    14-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02348606
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Jazz Pharmaceuticals
    Sponsor organisation address
    3180 Porter Drive, Palo Alto, United States, 94304
    Public contact
    Clinical Trial Disclosure & Transparency, Jazz Pharmaceuticals Inc., 001 2158323661,
    Scientific contact
    Clinical Trial Disclosure & Transparency, Jazz Pharmaceuticals Inc., 001 2158323661,
    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
    03 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of JZP-110 administered once daily for up to 12 weeks in doses of 37.5, 75, 150, and 300 mg compared to placebo in the treatment of excessive sleepiness in adult subjects with OSA.
    Protection of trial subjects
    Safety was assessed by the incidence of observed and reported adverse events (AEs), and changes in physical examination findings, electrocardiograms (ECGs), clinical laboratory tests, vital signs, 24-hour ABPM, and the Columbia-Suicide Severity Rating Scale (C-SSRS). Safety was assessed throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 40 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Canada: 10
    Country: Number of subjects enrolled
    United States: 448
    Worldwide total number of subjects
    474
    EEA total number of subjects
    16
    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)
    391
    From 65 to 84 years
    83
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Note: 476 subjects were enrolled and randomized, however 2 subjects never received drug. This resulted in 474 subjects comprising the safety population.

    Pre-assignment
    Screening details
    		 During screening, subjects completed a medical exam. An overnight PSG assessment followed by MWT and 24-hour ABPM were conducted at baseline. After successful completion of the screening and baseline visits subjects were randomized in a 1:1:2:2:2 ratio to receive 37.5, 75, 150, or 300 mg JZP-110 or placebo.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo condition.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo administered orally, QD, for the 12 week treatment phase.

    Arm title
    		 37.5 mg JZP-110
    Arm description
    		 37.5 mg JZP-110
    Arm type
    		 Experimental

    Investigational medicinal product name
    JZP-110
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.

    Arm title
    		 75 mg JZP-110
    Arm description
    		 75 mg JZP-110
    Arm type
    		 Experimental

    Investigational medicinal product name
    JZP-110
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.

    Arm title
    		 150 mg JZP-110
    Arm description
    		 150 mg JZP-110
    Arm type
    		 Experimental

    Investigational medicinal product name
    JZP-110
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.

    Arm title
    		 300 mg JZP-110
    Arm description
    		 300 mg JZP-110
    Arm type
    		 Experimental

    Investigational medicinal product name
    JZP-110
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.

    Number of subjects in period 1
    		Placebo 37.5 mg JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg JZP-110
    Started
    119
    58
    62
    117
    118
    Completed
    101
    49
    54
    106
    94
    Not completed
    18
    9
    8
    11
    24
         Consent withdrawn by subject
    4
    2
    2
    1
    4
         Adverse event, non-fatal
    4
    3
    2
    5
    16
         Other reasons
    6
    3
    4
    3
    1
         Lost to follow-up
    -
    1
    -
    -
    2
         Treatment Noncompliant
    2
    -
    -
    -
    1
         Protocol deviation
    2
    -
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo condition.

    Reporting group title
    37.5 mg JZP-110
    Reporting group description
    		 37.5 mg JZP-110

    Reporting group title
    75 mg JZP-110
    Reporting group description
    		 75 mg JZP-110

    Reporting group title
    150 mg JZP-110
    Reporting group description
    		 150 mg JZP-110

    Reporting group title
    300 mg JZP-110
    Reporting group description
    		 300 mg JZP-110

    Reporting group values
    		 Placebo 37.5 mg JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg JZP-110 Total
    Number of subjects
    		 119 58 62 117 118 474
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.1 ± 11.41 57.1 ± 10.19 54.4 ± 11.46 52.7 ± 10.57 53.2 ± 10.62 -
    Gender categorical
    Units: Subjects
        Female
    		 42 19 27 45 44 177
        Male
    		 77 39 35 72 74 297

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo condition.

    Reporting group title
    37.5 mg JZP-110
    Reporting group description
    		 37.5 mg JZP-110

    Reporting group title
    75 mg JZP-110
    Reporting group description
    		 75 mg JZP-110

    Reporting group title
    150 mg JZP-110
    Reporting group description
    		 150 mg JZP-110

    Reporting group title
    300 mg JZP-110
    Reporting group description
    		 300 mg JZP-110

    Primary: Change in Maintenance of Wakefulness Test (MWT) from Baseline to Week 12

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    End point title
    		 Change in Maintenance of Wakefulness Test (MWT) from Baseline to Week 12
    End point description
    Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12.
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Placebo 37.5 mg JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg JZP-110
    Number of subjects analysed
    114
    56
    58
    116
    115
    Units: minutes
        least squares mean (standard error)
    0.21 ± 0.997
    4.74 ± 1.418
    9.08 ± 1.358
    10.96 ± 0.973
    12.99 ± 1.038
    Statistical analysis title
    		 Change in the MWT
    Statistical analysis description
    A hierarchical testing procedure was used to make the following comparisons: JZP-110 300 mg vs. Placebo: p <0.0001 JZP-110 150 mg vs. Placebo: p <0.0001 JZP-110 75 mg vs. Placebo: p <0.0001 JZP-110 37.5 mg vs. Placebo: p = .0086
    Comparison groups
    Placebo v 37.5 mg JZP-110 v 75 mg JZP-110 v 150 mg JZP-110 v 300 mg JZP-110
    Number of subjects included in analysis
    459
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 MMRM
    Confidence interval

    Primary: Change in ESS Score from Baseline to Week 12

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    End point title
    		 Change in ESS Score from Baseline to Week 12
    End point description
    Change in ESS score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness.
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Placebo 37.5 mg JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg JZP-110
    Number of subjects analysed
    114
    56
    58
    116
    115
    Units: points on a scale
        least squares mean (standard error)
    -3.3 ± 0.45
    -5.1 ± 0.64
    -5.0 ± 0.62
    -7.7 ± 0.44
    -7.9 ± 0.46
    Statistical analysis title
    		 Change in the ESS
    Statistical analysis description
    A hierarchical testing procedure was used to make the following comparisons: JZP-110 300 mg vs. Placebo: p <0.0001 JZP-110 150 mg vs. Placebo: p <0.0001 JZP-110 75 mg vs. Placebo: p = 0.0233 JZP-110 37.5 mg vs. Placebo: p = 0.0161
    Comparison groups
    Placebo v 37.5 mg JZP-110 v 75 mg JZP-110 v 150 mg JZP-110 v 300 mg JZP-110
    Number of subjects included in analysis
    459
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 MMRM
    Confidence interval

    Secondary: Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12

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    End point title
    		 Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12
    End point description
    Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. This is the key secondary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Placebo 37.5 mg JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg JZP-110
    Number of subjects analysed
    114
    56
    58
    116
    115
    Units: percentage of subjects
        number (not applicable)
    49.1
    55.4
    72.4
    89.7
    88.7
    Statistical analysis title
    		 Subjects Reported Improved on the PGIc at Week 12
    Statistical analysis description
    A hierarchical testing procedure was used to make the following comparisons: JZP-110 300 mg vs. Placebo: p <0.0001 JZP-110 150 mg vs. Placebo: p <0.0001 JZP-110 75 mg vs. Placebo: p = 0.0035 JZP-110 37.5 mg vs. Placebo: p = 0.4447
    Comparison groups
    Placebo v 37.5 mg JZP-110 v 75 mg JZP-110 v 150 mg JZP-110 v 300 mg JZP-110
    Number of subjects included in analysis
    459
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Change in Sleep Latency Time on each of the 5 MWT trials at Week 12

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    End point title
    		 Change in Sleep Latency Time on each of the 5 MWT trials at Week 12
    End point description
    Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at week 12.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo 37.5 mg JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg JZP-110
    Number of subjects analysed
    114
    56
    58
    116
    115
    Units: minutes
    least squares mean (standard error)
        Trial 1
    -0.40 ± 1.327
    3.03 ± 1.881
    5.77 ± 1.808
    10.87 ± 1.284
    12.48 ± 1.401
        Trial 2
    -0.44 ± 1.380
    6.93 ± 1.928
    9.47 ± 1.849
    11.91 ± 1.332
    14.94 ± 1.425
        Trial 3
    0.58 ± 1.294
    3.59 ± 1.837
    11.32 ± 1.751
    11.50 ± 1.261
    10.90 ± 1.340
        Trial 4
    1.29 ± 1.305
    6.11 ± 1.845
    9.04 ± 1.794
    8.93 ± 1.272
    11.94 ± 1.359
        Trial 5
    0.18 ± 1.361
    3.57 ± 1.952
    7.75 ± 1.839
    8.05 ± 1.347
    7.59 ± 1.432
    No statistical analyses for this end point

    Secondary: Change in the mean sleep latency time as determined from the first 4 trials of a 40-minute MWT from Baseline to Week 4

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    End point title
    		 Change in the mean sleep latency time as determined from the first 4 trials of a 40-minute MWT from Baseline to Week 4
    End point description
    Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to week 4.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    End point values
    		 Placebo 37.5 mg JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg JZP-110
    Number of subjects analysed
    114
    56
    58
    116
    115
    Units: minutes
        least squares mean (standard error)
    1.24 ± 0.942
    4.53 ± 1.360
    7.20 ± 1.307
    11.69 ± 0.932
    13.77 ± 0.976
    No statistical analyses for this end point

    Secondary: Change in ESS Score from Baseline to Week 1, Week 4, and Week 8

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    End point title
    		 Change in ESS Score from Baseline to Week 1, Week 4, and Week 8
    End point description
    Change in ESS score from baseline to weeks 1, 4, and 8.
    End point type
    Secondary
    End point timeframe
    Baseline to Weeks 1, 4, and 8
    End point values
    		 Placebo 37.5 mg JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg JZP-110
    Number of subjects analysed
    114
    56
    58
    116
    115
    Units: points on a scale
    least squares mean (standard error)
        Week 1
    -2.6 ± 0.47
    -4.5 ± 0.66
    -4.4 ± 0.65
    -5.5 ± 0.46
    -6.6 ± 0.46
        Week 4
    -2.9 ± 0.45
    -4.7 ± 0.65
    -4.8 ± 0.63
    -6.1 ± 0.45
    -6.6 ± 0.46
        Week 8
    -3.8 ± 0.49
    -4.7 ± 0.70
    -6.3 ± 0.67
    -6.9 ± 0.48
    -7.7 ± 0.50
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8

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    End point title
    		 Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8
    End point description
    Percentage of subjects reported as improved (minimally, much, very much improved) on the PGIc at Weeks 1, 4, and 8.
    End point type
    Secondary
    End point timeframe
    Weeks 1, 4, and 8
    End point values
    		 Placebo 37.5 mg JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg JZP-110
    Number of subjects analysed
    114
    56
    58
    116
    115
    Units: percentage of subjects
    number (not applicable)
        Week 1
    47.4
    58.9
    65.5
    78.3
    82.5
        Week 4
    53.5
    60.7
    77.6
    84.5
    84.3
        Week 8
    57.0
    57.1
    79.3
    88.8
    87.8
    No statistical analyses for this end point

    Secondary: Percentage of subjects reported as improved on the CGIc at Week 12

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    End point title
    		 Percentage of subjects reported as improved on the CGIc at Week 12
    End point description
    Percentage of subjects reported as improved (minimally, much, very much) in CGIc at Week 12.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo 37.5 mg JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg JZP-110
    Number of subjects analysed
    114
    56
    58
    116
    115
    Units: percentage of subjects
        number (not applicable)
    49.1
    58.9
    70.7
    90.5
    88.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8

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    End point title
    		 Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8
    End point description
    Percentage of subjects reported as improved (minimally, much, very much) on the CGIc at Weeks 1, 4, and 8.
    End point type
    Secondary
    End point timeframe
    Weeks 1, 4, and 8
    End point values
    		 Placebo 37.5 mg JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg JZP-110
    Number of subjects analysed
    114
    56
    58
    116
    115
    Units: percentage of subjects
    number (not applicable)
        Week 1
    46.5
    62.5
    60.3
    75.7
    82.6
        Week 4
    52.6
    60.7
    77.6
    85.2
    81.7
        Week 8
    49.1
    55.4
    74.1
    87.8
    87.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The Safety Population consisted of all subjects who received at least 1 dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    37.5 mg JZP-110
    Reporting group description
    		 -

    Reporting group title
    75 mg JZP-110
    Reporting group description
    		 -

    Reporting group title
    150 mg JZP-110
    Reporting group description
    		 -

    Reporting group title
    300 mg JZP-110
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo 37.5 mg JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg JZP-110
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 119 (1.68%)
    2 / 58 (3.45%)
    0 / 62 (0.00%)
    1 / 117 (0.85%)
    0 / 118 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct obstruction
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Streptococcal endocarditis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    1 / 117 (0.85%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo 37.5 mg JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg JZP-110
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 119 (25.21%)
    17 / 58 (29.31%)
    21 / 62 (33.87%)
    41 / 117 (35.04%)
    60 / 118 (50.85%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 119 (8.40%)
    4 / 58 (6.90%)
    5 / 62 (8.06%)
    10 / 117 (8.55%)
    17 / 118 (14.41%)
         occurrences all number
    13
    4
    5
    11
    20
    General disorders and administration site conditions
    Feeling jittery
         subjects affected / exposed
    0 / 119 (0.00%)
    3 / 58 (5.17%)
    3 / 62 (4.84%)
    1 / 117 (0.85%)
    7 / 118 (5.93%)
         occurrences all number
    0
    3
    3
    1
    8
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    7 / 119 (5.88%)
    3 / 58 (5.17%)
    3 / 62 (4.84%)
    10 / 117 (8.55%)
    12 / 118 (10.17%)
         occurrences all number
    7
    3
    3
    11
    16
    Diarrhoea
         subjects affected / exposed
    1 / 119 (0.84%)
    1 / 58 (1.72%)
    3 / 62 (4.84%)
    5 / 117 (4.27%)
    8 / 118 (6.78%)
         occurrences all number
    2
    1
    3
    5
    8
    Dry mouth
         subjects affected / exposed
    2 / 119 (1.68%)
    1 / 58 (1.72%)
    1 / 62 (1.61%)
    5 / 117 (4.27%)
    9 / 118 (7.63%)
         occurrences all number
    2
    1
    1
    5
    10
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 119 (0.00%)
    3 / 58 (5.17%)
    0 / 62 (0.00%)
    1 / 117 (0.85%)
    0 / 118 (0.00%)
         occurrences all number
    0
    5
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 58 (1.72%)
    2 / 62 (3.23%)
    6 / 117 (5.13%)
    16 / 118 (13.56%)
         occurrences all number
    0
    1
    2
    6
    16
    Insomnia
         subjects affected / exposed
    2 / 119 (1.68%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    3 / 117 (2.56%)
    11 / 118 (9.32%)
         occurrences all number
    2
    1
    0
    3
    12
    Irritability
         subjects affected / exposed
    0 / 119 (0.00%)
    3 / 58 (5.17%)
    0 / 62 (0.00%)
    4 / 117 (3.42%)
    1 / 118 (0.85%)
         occurrences all number
    0
    3
    0
    4
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 119 (6.72%)
    2 / 58 (3.45%)
    1 / 62 (1.61%)
    7 / 117 (5.98%)
    8 / 118 (6.78%)
         occurrences all number
    9
    2
    1
    7
    10
    Sinusitis
         subjects affected / exposed
    3 / 119 (2.52%)
    1 / 58 (1.72%)
    4 / 62 (6.45%)
    0 / 117 (0.00%)
    3 / 118 (2.54%)
         occurrences all number
    3
    2
    4
    0
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 119 (0.84%)
    1 / 58 (1.72%)
    3 / 62 (4.84%)
    9 / 117 (7.69%)
    14 / 118 (11.86%)
         occurrences all number
    1
    1
    3
    9
    16

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Sep 2015
    This amendment made changes to the eligibility criteria.
    08 Feb 2016
    This amendment was made to further support enrollment of a representative patient sample, to clarify enrollment criteria, and to incorporate feedback from FDA about the proposed statistical analysis.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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