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    Clinical Trial Results:
    A Six-Week, Double-Blind, Placebo-Controlled, Randomized-Withdrawal, 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
    		 2014-005515-16
    Trial protocol
    		 FI   SE  
    Global end of trial date
    11 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2017
    First version publication date
    15 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    14-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02348619
    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 2158323750,
    Scientific contact
    Clinical Trial Disclosure & Transparency, Jazz Pharmaceuticals Inc., 001 2158323750,
    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
    25 Jan 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 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 compared to placebo in the treatment of excessive sleepiness in adult subjects with OSA.
    Protection of trial subjects
    The following measures were repeatedly assessed throughout the course of the study to monitor subject safety: (1) Assessment of adverse events and serious adverse events, (2) clinical laboratory tests, (3) medical history, (4) full review of body system through physical examination, (5) vital signs assessment, (6) polysomnography, and (7) administration of the columbia-suicide severity rating scale.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 May 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 30 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 7
    Country: Number of subjects enrolled
    Finland: 18
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    United States: 141
    Worldwide total number of subjects
    174
    EEA total number of subjects
    33
    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)
    140
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The Screening phase involved a standard medical screening visit. Following screening, subjects entered the Titration phase.

    Period 1
    Period 1 title
    Titration Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 JZP-110
    Arm description
    		 -
    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
    Start at 75 mg, titrate up to 150 or 300 mg, or down at any time.

    Number of subjects in period 1
    		JZP-110
    Started
    174
    Completed
    157
    Not completed
    17
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    6
         Other
    7
         Lost to follow-up
    1
         Treatment noncompliant
    1
         Protocol deviation
    1
    Period 2
    Period 2 title
    Stable-Dose Phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 JZP-110
    Arm description
    		 -
    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 who were titrated to an efficacious and tolerable dose in the Titration phase remained on the same dose regimen in the Stable-Dose phase.

    Number of subjects in period 2
    		JZP-110
    Started
    157
    Completed
    124
    Not completed
    33
         Consent withdrawn by subject
    4
         Other
    2
         Randomization criteria not met
    21
         Lost to follow-up
    3
         Sponsor decision
    1
         Protocol deviation
    1
         Lack of efficacy
    1
    Period 3
    Period 3 title
    Double-Blind Withdrawal Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    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
    Subjects in the Double-Blind Withdrawal phase who did not receive JZP-110 received placebo for 2 weeks.

    Arm title
    		 JZP-110
    Arm description
    		 -
    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 who received JZP-110 in the Double-Blind Withdrawal phase received the same dose as received in the Stable-Dose phase.

    Number of subjects in period 3
    		Placebo JZP-110
    Started
    62
    62
    Completed
    62
    60
    Not completed
    0
    2
         Consent withdrawn by subject
    -
    1
         Randomization criteria not met
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Titration Phase
    Reporting group description
    		 -

    Reporting group values
    		 Titration Phase Total
    Number of subjects
    		 174 174
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 140 140
        From 65-84 years
    		 34 34
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.8 ( 10.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 67 67
        Male
    		 107 107

    End points

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    End points reporting groups
    Reporting group title
    JZP-110
    Reporting group description
    		 -
    Reporting group title
    JZP-110
    Reporting group description
    		 -
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    JZP-110
    Reporting group description
    		 -

    Primary: Change in the Maintenance of Wakefulness Test (MWT)

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    End point title
    		 Change in the Maintenance of Wakefulness Test (MWT)
    End point description
    Change in the mean sleep latency time as determined from the first four trials of a 40-minute MWT from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase.
    End point type
    Primary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    62
    60
    Units: minutes
        least squares mean (standard error)
    -12.11 ( 1.326 )
    -0.96 ( 1.350 )
    Statistical analysis title
    		 Change in the MWT
    Comparison groups
    JZP-110 v Placebo
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval

    Primary: Change in the Epworth Sleepiness Scale (ESS)

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    End point title
    		 Change in the Epworth Sleepiness Scale (ESS)
    End point description
    Change in ESS score from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal phase.
    End point type
    Primary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    62
    60
    Units: points on a scale
        least squares mean (standard error)
    4.5 ( 0.71 )
    -0.1 ( 0.73 )
    Statistical analysis title
    		 Change in the ESS
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Patient Global Impression of Change (PGIc)

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    End point title
    		 Patient Global Impression of Change (PGIc)
    End point description
    Percentage of subjects reported as worse (minimally, much, or very much) on the PGIc at the end of the Double-blind Withdrawal Phase.
    End point type
    Secondary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    62
    60
    Units: percentage of subjects
        number (not applicable)
    50
    20
    Statistical analysis title
    		 PGIc
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0005
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Clinical Global Impression of Change (CGIc)

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    End point title
    		 Clinical Global Impression of Change (CGIc)
    End point description
    Percentage of subjects reported as worse (minimally, much, and very much) on the CGIc at the end of the Double-blind Withdrawal Phase.
    End point type
    Secondary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    62
    60
    Units: percentage of subjects
        number (not applicable)
    59
    22
    No statistical analyses for this end point

    Secondary: Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10)

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    End point title
    		 Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10)
    End point description
    Change is total score from the end of the stable dose phase to the end of the double blind withdrawal phase.
    End point type
    Secondary
    End point timeframe
    Week 4 to Week 6
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    62
    60
    Units: points
        least squares mean (standard error)
    -1.31 ( 0.381 )
    -0.15 ( 0.393 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Safety data are summarized for all subjects who received at least 1 dose of study medication across all phases.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Placebo (randomized withdrawal)
    Reporting group description
    		 During the randomized withdrawal phase only

    Reporting group title
    JZP-110 (entire study)
    Reporting group description
    		 Across the entire study

    Serious adverse events
    		 Placebo (randomized withdrawal) JZP-110 (entire study)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 174 (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 (randomized withdrawal) JZP-110 (entire study)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 62 (0.00%)
    58 / 174 (33.33%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 62 (0.00%)
    9 / 174 (5.17%)
         occurrences all number
    0
    9
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 62 (0.00%)
    20 / 174 (11.49%)
         occurrences all number
    0
    27
    Dizziness
         subjects affected / exposed
    0 / 62 (0.00%)
    14 / 174 (8.05%)
         occurrences all number
    0
    14
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    0 / 62 (0.00%)
    13 / 174 (7.47%)
         occurrences all number
    0
    16
    Nausea
         subjects affected / exposed
    0 / 62 (0.00%)
    13 / 174 (7.47%)
         occurrences all number
    0
    14
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 62 (0.00%)
    11 / 174 (6.32%)
         occurrences all number
    0
    11

    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 inclusion/exclusion criteria.
    09 Feb 2016
    This amendment was made to further support enrollment of a representative patient sample and clarify enrollment criteria.

    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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