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    Clinical Trial Results:
    A Long-Term, Safety and Maintenance of Efficacy Study of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or Obstructive Sleep Apnea

    Summary
    EudraCT number
    2014-005489-31
    Trial protocol
    FI   DE   NL   FR  
    Global end of trial date
    08 Dec 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Dec 2018
    First version publication date
    23 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    14-005
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02348632
    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
    08 Dec 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of JZP-110 administered once daily for up to 52 weeks in doses of 75, 150, and 300 mg.
    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, 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
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Finland: 17
    Country: Number of subjects enrolled
    France: 12
    Country: Number of subjects enrolled
    Germany: 31
    Country: Number of subjects enrolled
    Canada: 28
    Country: Number of subjects enrolled
    United States: 545
    Country: Number of subjects enrolled
    Italy: 4
    Worldwide total number of subjects
    643
    EEA total number of subjects
    70
    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)
    547
    From 65 to 84 years
    96
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Note: Subjects who had completed prior studies with JZP-110 (14-002, 14-003, 14-004, 15-004, 15-005, ADX‑N05 201, or ADX‑N05 202) and met the screening criteria were eligible to enroll. 643 subjects comprised the safety population.

    Pre-assignment
    Screening details
    The Screening phase involved a standard medical screening visit.

    Period 1
    Period 1 title
    Open-label period
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Combined JZP-110
    Arm description
    Subjects completed a 2-week titration phase. They then entered the maintenance phase of up to 50 weeks at the stable dose that was reached at the end of the Titration Phase.
    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
    Titration phase: Start at 75 mg, titrate up 1 dose level once every 3 days to a maximum of 300 mg. Subjects could also titrate down if needed. Subjects entered the maintenance phase at the stable dose that was reached at the end of the Titration Phase. Only 3 dose adjustments were allowed during the first 12 weeks of the maintenance phase after which no changes were permitted.

    Number of subjects in period 1
    Combined JZP-110
    Started
    643
    Completed
    458
    Not completed
    185
         Consent withdrawn by subject
    27
         Adverse event, non-fatal
    61
         Other
    1
         Lost to follow-up
    14
         Treatment noncompliant
    7
         Sponsor decision
    10
         Lack of efficacy
    54
         Protocol deviation
    11
    Period 2
    Period 2 title
    Randomized Withdrawal Period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo administered orally, QD, for the 2-week randomized withdrawal period.
    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 2-week randomized withdrawal period.

    Arm title
    JZP-110
    Arm description
    JZP-110 administered orally, QD, for the 2-week randomized withdrawal period, at the same dose subjects were currently receiving.
    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
    JZP-110 administered orally, QD, at the dose subjects were receiving during the open-label maintenance phase.

    Number of subjects in period 2 [1]
    Placebo JZP-110
    Started
    142
    140
    Completed
    141
    137
    Not completed
    1
    3
         Consent withdrawn by subject
    -
    1
         Lost to follow-up
    1
    -
         Treatment noncompliant
    -
    1
         Protocol deviation
    -
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 282 subjects were treated in the Randomized Withdrawal Period, and 278 subjects completed the Randomized Withdrawal Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Open-label period
    Reporting group description
    -

    Reporting group values
    Open-label period Total
    Number of subjects
    643 643
    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)
    547 547
        From 65-84 years
    96 96
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    49.31 ( 14.155 ) -
    Gender categorical
    Units: Subjects
        Female
    306 306
        Male
    337 337

    End points

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    End points reporting groups
    Reporting group title
    Combined JZP-110
    Reporting group description
    Subjects completed a 2-week titration phase. They then entered the maintenance phase of up to 50 weeks at the stable dose that was reached at the end of the Titration Phase.
    Reporting group title
    Placebo
    Reporting group description
    Placebo administered orally, QD, for the 2-week randomized withdrawal period.

    Reporting group title
    JZP-110
    Reporting group description
    JZP-110 administered orally, QD, for the 2-week randomized withdrawal period, at the same dose subjects were currently receiving.

    Primary: Change in Epworth Sleepiness Scale (ESS) Score

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    End point title
    Change in Epworth Sleepiness Scale (ESS) Score
    End point description
    Change in ESS score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. A negative change from baseline represents improvement in excessive sleepiness.
    End point type
    Primary
    End point timeframe
    Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)
    End point values
    Placebo JZP-110
    Number of subjects analysed
    141
    139
    Units: points on a scale
        least squares mean (standard error)
    5.3 ( 0.41 )
    1.6 ( 0.41 )
    Statistical analysis title
    Change in ESS Score
    Statistical analysis description
    JZP-110 v. Placebo: <0.0001
    Comparison groups
    Placebo v JZP-110
    Number of subjects included in analysis
    280
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Confidence interval

    Secondary: Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)

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    End point title
    Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)
    End point description
    Percentage of subjects reported as worse (minimally worse, much worse, or very much worse) on the PGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.
    End point type
    Secondary
    End point timeframe
    Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)
    End point values
    Placebo JZP-110
    Number of subjects analysed
    141
    139
    Units: percentage of subjects
        number (not applicable)
    64.5
    28.2
    No statistical analyses for this end point

    Secondary: Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)

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    End point title
    Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)
    End point description
    Subjects reported as worse (very much worse, much worse, and minimally worse) on the CGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.
    End point type
    Secondary
    End point timeframe
    Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)
    End point values
    Placebo JZP-110
    Number of subjects analysed
    141
    139
    Units: percentage of subjects
        number (not applicable)
    63.8
    28.7
    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. Adverse events are reported across the entire study (e.g., the open-label and randomized withdrawal periods combined).
    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
    Combined JZP-110
    Reporting group description
    -

    Serious adverse events
    Placebo Combined JZP-110
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 142 (0.00%)
    27 / 643 (4.20%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer stage I
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stillbirth
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatomegaly
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 643 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination, auditory
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 643 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anaemia postoperative
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 643 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear canal injury
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural hypotension
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 142 (0.00%)
    4 / 643 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 643 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cluster headache
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 643 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal vein occlusion
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 643 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 643 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Combined JZP-110
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 142 (2.11%)
    269 / 643 (41.84%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 142 (0.00%)
    71 / 643 (11.04%)
         occurrences all number
    0
    92
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 142 (0.70%)
    57 / 643 (8.86%)
         occurrences all number
    1
    68
    Dry mouth
         subjects affected / exposed
    0 / 142 (0.00%)
    47 / 643 (7.31%)
         occurrences all number
    0
    55
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 142 (0.00%)
    46 / 643 (7.15%)
         occurrences all number
    0
    52
    Insomnia
         subjects affected / exposed
    1 / 142 (0.70%)
    51 / 643 (7.93%)
         occurrences all number
    1
    68
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 142 (0.70%)
    54 / 643 (8.40%)
         occurrences all number
    1
    65
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 142 (0.00%)
    32 / 643 (4.98%)
         occurrences all number
    0
    39
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 142 (0.00%)
    32 / 643 (4.98%)
         occurrences all number
    0
    33

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Feb 2015
    This amendment made changes to clarify enrollment criteria.
    11 Sep 2015
    This amendment made changes to clarify enrollment criteria.
    02 Feb 2016
    This amendment added the randomized withdrawal period, along with additional study procedures and data analyses as a result of this period, and also increased the maximum enrollment. Changes to clarify the enrollment criteria were also made.
    17 Nov 2016
    This amendment was made to clarify the number of subjects to be randomized into the randomized withdrawal period.

    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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