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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects with Excessive sleepiness Due to Obstructive Sleep Apnea

    Summary
    EudraCT number
    		 2015-003930-28
    Trial protocol
    		 DE   BE  
    Global end of trial date
    28 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jun 2020
    First version publication date
    14 Jun 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    15-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02806895
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Jazz Pharmaceuticals Inc.
    Sponsor organisation address
    3170 Porter Drive, Palo Alto, United States, 94304
    Public contact
    Director, Disclosure & Transparency, Jazz Pharmaceuticals Inc., 001 2158323750, ClinicalTrialDisclosure@JazzPharma.com
    Scientific contact
    Grace Wang, MD, Jazz Pharmaceuticals Inc., 001 2158323750, ClinicalTrialDisclosure@JazzPharma.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
    28 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the effect of JZP-110 on driving performance.
    Protection of trial subjects
    All subjects were to provide written informed consent, in accordance with local IEC/IRB requirements, before the performance of any study-related procedures.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jul 2016
    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
    Netherlands: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    34
    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)
    33
    From 65 to 84 years
    1
    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 crossover treatment phase.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo
    Arm description
    		 Subjects received a single oral daily dose of placebo for 7 days in Treatment Period 1 or Treatment Period 2 in a counterbalanced order.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single oral daily dose of placebo for 7 days in Treatment Period 1 or Treatment Period 2 in a counterbalanced order.

    Arm title
    		 JZP-110
    Arm description
    		 Subjects received a single oral daily dose of JZP-110 (150 mg/day for 3 days) then JZP-110 (300 mg/day for 4 days) during Treatment Period 1 or Treatment Period 2 in a counterbalanced order.
    Arm type
    		 Experimental

    Investigational medicinal product name
    solriamfetol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single oral daily dose of JZP-110 (150 mg/day for 3 days) then JZP-110 (300 mg/day for 4 days) during Treatment Period 1 or Treatment Period 2 in a counterbalanced order.

    Number of subjects in period 1
    		Placebo JZP-110
    Started
    34
    34
    JZP-110/Placebo
    17 [1]
    17 [2]
    Placebo/JZP-110
    17 [3]
    17 [4]
    Completed
    33
    33
    Not completed
    1
    1
         Sponsor decision
    1
    1
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This was a crossover study where all subjects received placebo and JZP-110 in a counterbalanced order between treatment sequence 1 and treatment sequence 2. System error as system automatically doubles the enrollment.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This was a crossover study where all subjects received placebo and JZP-110 in a counterbalanced order between treatment sequence 1 and treatment sequence 2. System error as system automatically doubles the enrollment.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This was a crossover study where all subjects received placebo and JZP-110 in a counterbalanced order between treatment sequence 1 and treatment sequence 2. System error as system automatically doubles the enrollment.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This was a crossover study where all subjects received placebo and JZP-110 in a counterbalanced order between treatment sequence 1 and treatment sequence 2. System error as system automatically doubles the enrollment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 34 34
    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 (21-65 years)
    		 34 34
    Age continuous
    Units: years
        median (standard deviation)
    		 51.6 ± 12.30 -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 30 30

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single oral daily dose of placebo for 7 days in Treatment Period 1 or Treatment Period 2 in a counterbalanced order.

    Reporting group title
    JZP-110
    Reporting group description
    		 Subjects received a single oral daily dose of JZP-110 (150 mg/day for 3 days) then JZP-110 (300 mg/day for 4 days) during Treatment Period 1 or Treatment Period 2 in a counterbalanced order.

    Primary: Standard deviation of lateral position (SDLP) at 2 hours post-dose (approximately at Tmax)

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    End point title
    		 Standard deviation of lateral position (SDLP) at 2 hours post-dose (approximately at Tmax)
    End point description
    Subjects were instructed to drive with steady lateral position between the delineated boundaries of the slower (right) traffic lane, while maintaining a constant speed of 95 kilometers (km) per hour (hr). Deviation was measured by the vehicle's speed and lateral distance to the left lane line and was continuously recorded. Individual improvement was defined as a decrease in SDLP below the negative value of threshold; individual impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
    End point type
    Primary
    End point timeframe
    2 hours post-dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    33 [1]
    34
    Units: centimeter (cm)
        least squares mean (standard error)
    19.92 ± 0.630
    18.83 ± 0.627
    Notes
    [1] - One subject did not receive placebo resulting in 33 subjects in the placebo group.
    Statistical analysis title
    		 SDLP at 2 Hours Post-dose (Approximately at Tmax)
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0062
    Method
    		 ANOVA
    Confidence interval

    Secondary: SDLP at 6 Hours Post-dose

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    End point title
    		 SDLP at 6 Hours Post-dose
    End point description
    Subjects were instructed to drive with steady lateral position between the delineated boundaries of the slower (right) traffic lane, while maintaining a constant speed of 95 kilometers (km) per hour (hr). Deviation was measured by the vehicle's speed and lateral distance to the left lane line and was continuously recorded. Individual improvement was defined as a decrease in SDLP below the negative value of threshold; individual impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
    End point type
    Secondary
    End point timeframe
    6 hours post-dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    32 [2]
    32 [3]
    Units: cm
        least squares mean (standard error)
    20.04 ± 0.632
    19.24 ± 0.631
    Notes
    [2] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    [3] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    Statistical analysis title
    		 SDLP at 6 Hours Post-dose
    Statistical analysis description
    The mean change in SDLP was analyzed using a repeated mixed effect ANOVA model. The model included treatment (JZP-110 and placebo), driving performance test (6 hours post-dose), treatment period, treatment sequence and treatment by driving performance test interaction as fixed effects and subject as a random effect. Total subjects in this analysis set was 32 for Placebo and 32 for JZP-110 not a total of 64 due to cross over design.
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0432
    Method
    		 ANOVA
    Confidence interval

    Secondary: Proportion of Subjects with Improved or Impaired Driving on JZP-110 Compared to Placebo at 2 Hours Post-dose

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    End point title
    		 Proportion of Subjects with Improved or Impaired Driving on JZP-110 Compared to Placebo at 2 Hours Post-dose
    End point description
    Improvement was defined as a decrease in SDLP comparing JZP-110 and placebo below the threshold and impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns. The maximum McNemar’s statistic was used as the test statistic.
    End point type
    Secondary
    End point timeframe
    2 hours of post-dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    33 [4]
    34 [5]
    Units: distribution of change
        number (not applicable)
    0
    0
    Notes
    [4] - The distribution of the change in driving performance (JZP-110/Placebo) could not be concluded.
    [5] - The distribution of the change in driving performance (JZP-110/Placebo) could not be concluded.
    No statistical analyses for this end point

    Secondary: Proportion of Subjects with Improved or Impaired Driving on JZP-110 Compared to Placebo at 6 Hours Post-dose

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    End point title
    		 Proportion of Subjects with Improved or Impaired Driving on JZP-110 Compared to Placebo at 6 Hours Post-dose
    End point description
    Improvement was defined as a decrease in SDLP comparing JZP-110 and placebo below the threshold and impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns. The maximum McNemar’s statistic was used as the test statistic.
    End point type
    Secondary
    End point timeframe
    6 hours post-dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    33 [6]
    34 [7]
    Units: distribution of change
        number (not applicable)
    0
    0
    Notes
    [6] - The distribution of the change in driving performance (JZP-110/Placebo) could not be concluded.
    [7] - The distribution of the change in driving performance (JZP-110/Placebo) could not be concluded.
    No statistical analyses for this end point

    Secondary: Standard Deviation of Speed (SDS) at 2 Hours Post-dose

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    End point title
    		 Standard Deviation of Speed (SDS) at 2 Hours Post-dose
    End point description
    Mean SDS was a common measure of the driver's ability to maintain a constant driving speed. Variations in driving speed were recorded and analyzed.
    End point type
    Secondary
    End point timeframe
    2 hours post-dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    33 [8]
    34
    Units: kilometers/hour (km/hr)
        least squares mean (standard error)
    2.55 ± 0.099
    2.62 ± 0.098
    Notes
    [8] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    Statistical analysis title
    		 SDS 2 Hours Post-dose
    Statistical analysis description
    The Driving Performance parameter was analyzed using a repeated mixed effect ANOVA model. The model included treatment (JZP-110 and placebo), driving performance test (2 hours post-dose), treatment period, treatment sequence and treatment by driving performance test interaction as fixed effects and subject as a random effect. Total subjects in this analysis set was 33 for Placebo and 34 for JZP-110 not a total of 67 due to cross over design.
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4116
    Method
    		 ANOVA
    Confidence interval

    Secondary: SDS at 6 Hours Post-dose

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    End point title
    		 SDS at 6 Hours Post-dose
    End point description
    Mean SDS was a common measure of the driver's ability to maintain a constant driving speed. Variations in driving speed were recorded and analyzed.
    End point type
    Secondary
    End point timeframe
    6 hours post-dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    32 [9]
    32 [10]
    Units: km/hr
        least squares mean (standard error)
    2.84 ± 0.100
    2.73 ± 0.099
    Notes
    [9] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    [10] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    Statistical analysis title
    		 SDS 6 Hours Post-dose
    Statistical analysis description
    The Driving Performance parameter was analyzed using a repeated mixed effect ANOVA model. The model included treatment (JZP-110 and placebo), driving performance test (6 hours post-dose), treatment period, treatment sequence and treatment by driving performance test interaction as fixed effects and subject as a random effect. Total subjects in this analysis set was 32 for Placebo and 32 for JZP-110 not a total of 64 due to cross over design.
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1991
    Method
    		 ANOVA
    Confidence interval

    Secondary: Number of Lapses in Driving Test at 2 Hours Post-dose

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    End point title
    		 Number of Lapses in Driving Test at 2 Hours Post-dose
    End point description
    Number of driving lapses (also known as lane drift, was defined as deviations > 100 cm from the mean lateral position and from the absolute lateral position for 8 seconds. Driving performance will be assessed using a standardized on-road driving test on Day 7 (Visit 4) and on Day 14 (Visit 5). A practice driving test was done during the screening period to familiarize the subject with the vehicle and test scenario, assess if the subject could adequately operate the manual transmission vehicle, and determine if any safety concerns existed that excluded the subject from participating in the study.
    End point type
    Secondary
    End point timeframe
    2 hour post-dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    33 [11]
    34
    Units: number of lapses
        least squares mean (standard error)
    2.89 ± 0.566
    1.76 ± 0.558
    Notes
    [11] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    Statistical analysis title
    		 Lapses in Driving Test at 2 hours Post-dose
    Statistical analysis description
    The Driving Performance parameter was analyzed using a repeated mixed effect ANOVA model. The model included treatment (JZP-110 and placebo), driving performance test (2 hours post-dose), treatment period, treatment sequence and treatment by driving performance test interaction as fixed effects and subject as a random effect. Total subjects in this analysis set was 33 for Placebo and 34 for JZP-110 not a total of 67 due to cross over design.
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0806
    Method
    		 ANOVA
    Confidence interval

    Secondary: Number of Lapses in Driving Test at 6 Hours Post-dose

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    End point title
    		 Number of Lapses in Driving Test at 6 Hours Post-dose
    End point description
    Number of driving lapses (also known as lane drift, was defined as deviations > 100 cm from the mean lateral position and from the absolute lateral position for 8 seconds. Driving performance will be assessed using a standardized on-road driving test on Day 7 (Visit 4) and on Day 14 (Visit 5). A practice driving test was done during the screening period to familiarize the subject with the vehicle and test scenario, assess if the subject could adequately operate the manual transmission vehicle, and determine if any safety concerns existed that excluded the subject from participating in the study.
    End point type
    Secondary
    End point timeframe
    6 hours post-dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    32 [12]
    32 [13]
    Units: number of lapses
        least squares mean (standard error)
    2.07 ± 0.573
    2.12 ± 0.573
    Notes
    [12] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    [13] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    Statistical analysis title
    		 Lapses in Driving Test at 6 hours Post-dose
    Statistical analysis description
    The Driving Performance parameter was analyzed using a repeated mixed effect ANOVA model. The model included treatment (JZP-110 and placebo), driving performance test (6 hours post-dose), treatment period, treatment sequence and treatment by driving performance test interaction as fixed effects and subject as a random effect. Total subjects in this analysis set was 32 for Placebo and 32 for JZP-110 not a total of 64 due to cross over design.
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9391
    Method
    		 ANOVA
    Confidence interval

    Secondary: Psychomotor Vigilance Test (PVT) Number of Lapses at 2 Hours Post-dose

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    End point title
    		 Psychomotor Vigilance Test (PVT) Number of Lapses at 2 Hours Post-dose
    End point description
    The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively). The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds. Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible. Lapses were measured as (RT > 500 msec).
    End point type
    Secondary
    End point timeframe
    2 hours post-dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    33 [14]
    34
    Units: RT > 500 msec
        least squares mean (standard error)
    6.37 ± 2.111
    2.71 ± 2.077
    Notes
    [14] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    Statistical analysis title
    		 PVT Number of Lapses at 2 Hours Post-dose
    Statistical analysis description
    PVT was analyzed using a repeated mixed effect ANOVA model. The model included treatment (JZP-110 and placebo), PVT test (2 hours post-dose), treatment period, treatment sequence and treatment by PVT test interaction as fixed effects and subject as a random effect. Number of errors of commission: number of responses without a stimulus, or false starts Inverse reaction time. Total subjects was 33 for Placebo and 34 for JZP-110 not a total of 67 due to cross over design.
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2116
    Method
    		 ANOVA
    Confidence interval

    Secondary: PVT Number of Lapses at 6 Hours Post-dose

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    End point title
    		 PVT Number of Lapses at 6 Hours Post-dose
    End point description
    The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively). The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds. Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible. Lapses were measured as Reaction Time (RT) in milliseconds > 500 milliseconds (RT > 500 msec).
    End point type
    Secondary
    End point timeframe
    6 hours post-dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    33 [15]
    33 [16]
    Units: RT > msec
        least squares mean (standard error)
    7.73 ± 2.111
    3.60 ± 2.086
    Notes
    [15] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    [16] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    Statistical analysis title
    		 PVT Number of Lapses at 6 Hours Post-dose
    Statistical analysis description
    PVT was analyzed using a repeated mixed effect ANOVA model. The model included treatment (JZP-110 and placebo), PVT test (6 hours post-dose), treatment period, treatment sequence and treatment by PVT test interaction as fixed effects and subject as a random effect. Number of errors of commission: number of responses without a stimulus, or false starts Inverse reaction time. Total subjects was 33 for Placebo and 33 for JZP-110 not a total of 66 due to cross over design.
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1604
    Method
    		 ANOVA
    Confidence interval

    Secondary: PVT Mean Reaction Time at 2 Hours Post-dose

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    End point title
    		 PVT Mean Reaction Time at 2 Hours Post-dose
    End point description
    The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively). The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds. Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible. Mean RT is measured in msec.
    End point type
    Secondary
    End point timeframe
    2 hours post-dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    33 [17]
    34
    Units: msec
        least squares mean (standard error)
    318.66 ± 19.307
    286.55 ± 19.004
    Notes
    [17] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    Statistical analysis title
    		 PVT Mean Reaction Time at 2 Hours Post-dose
    Statistical analysis description
    PVT was analyzed using a repeated mixed effect ANOVA model. The model included treatment (JZP-110 and placebo), PVT test (2 hours post-dose), treatment period, treatment sequence and treatment by PVT test interaction as fixed effects and subject as a random effect. Inverse reaction time: Each RT (ms) was divided by 1,000 and reciprocally transformed. The transformed values were then averaged. Total subjects was 33 for Placebo and 34 for JZP-110 not a total of 67 due to cross over design.
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2144
    Method
    		 ANOVA
    Confidence interval

    Secondary: PVT Mean Reaction Time at 6 Hours Post-dose

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    End point title
    		 PVT Mean Reaction Time at 6 Hours Post-dose
    End point description
    The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively). The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds. Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible. Mean RT is measured in msec.
    End point type
    Secondary
    End point timeframe
    6 hours post-dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    33 [18]
    33 [19]
    Units: msec
        least squares mean (standard error)
    341.37 ± 19.307
    286.88 ± 19.188
    Notes
    [18] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    [19] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    Statistical analysis title
    		 PVT Mean Reaction Time at 6 Hours Post-dose
    Statistical analysis description
    PVT was analyzed using a repeated mixed effect ANOVA model. The model included treatment (JZP-110 and placebo), PVT test (6 hours post-dose), treatment period, treatment sequence and treatment by PVT test interaction as fixed effects and subject as a random effect. Inverse reaction time: Each RT (ms) was divided by 1,000 and reciprocally transformed. The transformed values were then averaged. Total subjects was 33 for Placebo and 33 for JZP-110 not a total of 66 due to cross over design.
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0387
    Method
    		 ANOVA
    Confidence interval

    Secondary: PVT Inverse Reaction Time at 2 Hours Post-dose

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    End point title
    		 PVT Inverse Reaction Time at 2 Hours Post-dose
    End point description
    The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively). The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds. Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible. Inverse reaction time was expressed as 1/reaction time in msec.
    End point type
    Secondary
    End point timeframe
    2 hours post dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    33 [20]
    34
    Units: (1/RT(s))
        least squares mean (standard error)
    3.59 ± 0.111
    3.69 ± 0.110
    Notes
    [20] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    Statistical analysis title
    		 PVT Inverse Reaction Time at 2 Hours Post-dose
    Statistical analysis description
    PVT was analyzed using a repeated mixed effect ANOVA model. The model included treatment (JZP-110 and placebo), PVT test (2 hours post-dose), treatment period, treatment sequence and treatment by PVT test interaction as fixed effects and subject as a random effect. Inverse reaction time: Each RT (ms) was divided by 1,000 and reciprocally transformed. The transformed values were then averaged. Total subjects was 33 for Placebo and 34 for JZP-110 not a total of 67 due to cross over design.
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3426
    Method
    		 ANOVA
    Confidence interval

    Secondary: PVT Inverse Reaction Time at 6 Hours Post-dose

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    End point title
    		 PVT Inverse Reaction Time at 6 Hours Post-dose
    End point description
    The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively). The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds. Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible. Inverse reaction time was expressed as 1/reaction time in msec.
    End point type
    Secondary
    End point timeframe
    6 hours post-dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    33 [21]
    33 [22]
    Units: (1/RT(s))
        least squares mean (standard error)
    3.59 ± 0.111
    3.75 ± 0.110
    Notes
    [21] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    [22] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    Statistical analysis title
    		 PVT Inverse Reaction Time at 6 Hours Post-dose
    Statistical analysis description
    PVT was analyzed using a repeated mixed effect ANOVA model. The model included treatment (JZP-110 and placebo), PVT test (6 hours post-dose), treatment period, treatment sequence and treatment by PVT test interaction as fixed effects and subject as a random effect. Inverse reaction time: Each RT (ms) was divided by 1,000 and reciprocally transformed. The transformed values were then averaged. Total subjects was 33 for Placebo and 33 for JZP-110 not a total of 66 due to cross over design.
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1531
    Method
    		 ANOVA
    Confidence interval

    Secondary: PVT Number of Errors of Commission at 2 Hours Post-dose

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    End point title
    		 PVT Number of Errors of Commission at 2 Hours Post-dose
    End point description
    The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively). The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds. Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible. Errors of commission were measured as the number of responses without a stimulus or false starts with (RT < 100 msec).
    End point type
    Secondary
    End point timeframe
    2 hours post-dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    33 [23]
    34
    Units: RT < 100 msec
        least squares mean (standard error)
    2.40 ± 0.741
    1.82 ± 0.730
    Notes
    [23] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    Statistical analysis title
    		 PVT Number of Errors of Commission at 2 Hours Post
    Statistical analysis description
    PVT was analyzed using a repeated mixed effect ANOVA model. The model included treatment (JZP-110 and placebo), PVT test (2 hours post-dose), treatment period, treatment sequence and treatment by PVT test interaction as fixed effects and subject as a random effect. Number of errors of commission: number of responses without a stimulus, or false starts Inverse reaction time. Total subjects was 33 for Placebo and 34 for JZP-110 not a total of 67 due to cross over design.
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5603
    Method
    		 ANOVA
    Confidence interval

    Secondary: PVT Number of Errors of Commission at 6 Hours Post-dose

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    End point title
    		 PVT Number of Errors of Commission at 6 Hours Post-dose
    End point description
    The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively). The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds. Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible. Errors of commission were measured as the number of responses without a stimulus or false starts with (RT < 100 msec).
    End point type
    Secondary
    End point timeframe
    6 hours post-dose
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    33 [24]
    33 [25]
    Units: RT < 100 msec
        least squares mean (standard error)
    2.46 ± 0.741
    1.76 ± 0.740
    Notes
    [24] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    [25] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    Statistical analysis title
    		 PVT Number of Errors of Commission at 6 Hours Post
    Statistical analysis description
    PVT was analyzed using a repeated mixed effect ANOVA model. The model included treatment (JZP-110 and placebo), PVT test (6 hours post-dose), treatment period, treatment sequence and treatment by PVT test interaction as fixed effects and subject as a random effect. Number of errors of commission: number of responses without a stimulus, or false starts Inverse reaction time. Total subjects was 33 for Placebo and 33 for JZP-110 not a total of 66 due to cross over design.
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4851
    Method
    		 ANOVA
    Confidence interval

    Secondary: Toronto Hospital Alert Test (THAT)

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    End point title
    		 Toronto Hospital Alert Test (THAT)
    End point description
    The Toronto Hospital Alert Test (THAT) is a 10-item self-report questionnaire designed to measure perceived alertness in the preceding week. The THAT was administered at baseline and the end of each treatment period. The total score of THAT can range between 0 to 50 where the higher score indicates greater alertness.
    End point type
    Secondary
    End point timeframe
    post-treatment
    End point values
    		 Placebo JZP-110
    Number of subjects analysed
    33 [26]
    34
    Units: score on a scale
        least squares mean (standard error)
    23.94 ± 1.180
    27.52 ± 1.162
    Notes
    [26] - Subjects in the mITT population missing an assessment for an endpoint were excluded in the analysis.
    Statistical analysis title
    		 THAT
    Statistical analysis description
    THAT was analyzed using a mixed effect ANOVA model. The model included treatment (JZP-110 and placebo), treatment period, treatment sequence as fixed effects and subject as a random effect. Total subjects in this analysis set was 33 for Placebo and 34 JZP-110 not a total of 67 due to cross over design.
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0241
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the time written informed consent was obtained until the final study visit or early termination.
    Adverse event reporting additional description
    The Safety Population consisted of all subjects who received at least 1 dose of study medication. A treatment-emergent AE (TEAE), was defined as an AE that either began after first study drug dose or worsened after the first dose. When determining the percent of subjects who experienced an AE, multiple increases in severity were counted as one AE.
    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
    		 Subjects received a single oral daily dose of placebo for 7 days

    Reporting group title
    JZP-110
    Reporting group description
    		 Subjects received a single oral daily dose of JZP-110 (150 mg/day for 3 days) then JZP-110 (300 mg/day for 4 days)

    Serious adverse events
    		 Placebo JZP-110
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo JZP-110
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 33 (24.24%)
    15 / 34 (44.12%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 33 (6.06%)
    3 / 34 (8.82%)
         occurrences all number
    2
    3
    Headache
         subjects affected / exposed
    4 / 33 (12.12%)
    4 / 34 (11.76%)
         occurrences all number
    4
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 33 (6.06%)
    4 / 34 (11.76%)
         occurrences all number
    2
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 33 (0.00%)
    4 / 34 (11.76%)
         occurrences all number
    0
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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