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    Clinical Trial Results:
    A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) with an Open-label Safety Extension

    Summary
    EudraCT number
    		 2018-001311-79
    Trial protocol
    		 FR   GB   CZ   BE   DE   ES   FI   IT  
    Global end of trial date
    18 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    JZP080-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03533114
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 49,641
    Sponsors
    Sponsor organisation name
    Jazz Pharmaceuticals Inc.
    Sponsor organisation address
    3170 Porter Drive, Palo Alto, United States, 94304
    Public contact
    Director, Jazz Pharmaceuticals, +1 2158323750 , ClinicalTrialDisclosure@JazzPharma.com
    Scientific contact
    Director, Jazz Pharmaceuticals, +1 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
    30 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jun 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2020
    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 efficacy of JZP-258 in the treatment of IH.
    Protection of trial subjects
    A written informed consent form (ICF) was obtained before any study procedure were performed in the study and the date of the written consent was obtained and documented. Participants who participated in the pharmacokinetic (PK) assessments signed a separate ICF prior to any PK assessments being performed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Nov 2018
    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
    Poland: 4
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    Belgium: 11
    Country: Number of subjects enrolled
    Czechia: 4
    Country: Number of subjects enrolled
    Finland: 2
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    United States: 104
    Worldwide total number of subjects
    154
    EEA total number of subjects
    50
    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)
    144
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The safety population is categorized according to the presence or absence of medications used to treat IH symptoms at the time of study baseline.

    Pre-assignment
    Screening details
    		 The screening period was 14 to 30 days, with the option to rescreen once.

    Period 1
    Period 1 title
    Open Label Titration and Optimization
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Baseline evaluations were done prior to first dose. Study drug administration began on day 1. Participants were titrated to their optimal dose.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 On Baseline IH Medication
    Arm description
    		 Participants treated with medication for IH at baseline.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JZP-258
    Investigational medicinal product code
    Other name
    mixed oxybate salts; calcium, magnesium, potassium, sodium oxybate; Xywav
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were begun on JZP-258 either as a once nightly or twice nightly dosing regimen at the discretion of the investigator. The dosing regimen of JZP-258 could then be adjusted until an optimally effective and tolerable dosing regimen was established. Participants on Xyrem at baseline were switched to the same dose of JZP-258. The dosing regimen could then be adjusted until an optimally effective and tolerable dosing regimen was established (if needed.)

    Arm title
    		 Treatment Naive
    Arm description
    		 Participants not treated with medication for IH at baseline.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JZP258
    Investigational medicinal product code
    Other name
    mixed oxybate salts; calcium, magnesium, potassium, sodium oxybate; Xywav
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were begun on JZP-258 either as a once nightly or twice nightly dosing regimen at the discretion of the investigator. The dosing regimen of JZP-258 could then be adjusted until an optimally effective and tolerable dosing regimen was established.

    Number of subjects in period 1
    		On Baseline IH Medication Treatment Naive
    Started
    88
    66
    Completed
    72
    53
    Not completed
    16
    13
         Consent withdrawn by subject
    2
    -
         Non-Compliance with Study Drug
    -
    1
         Adverse event, non-fatal
    11
    8
         Lost to follow-up
    -
    1
         Lack of efficacy
    3
    1
         Withdrawal by subject
    -
    1
         Protocol deviation
    -
    1
    Period 2
    Period 2 title
    Stable Dose
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 On Baseline IH Medication
    Arm description
    		 Participants treated with medication for IH at baseline.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JZP-258
    Investigational medicinal product code
    Other name
    mixed oxybate salts; calcium, magnesium, potassium, sodium oxybate; Xywav
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Participants continued on their optimized stable dose.

    Arm title
    		 Treatment Naive
    Arm description
    		 Participants not treated with medication for IH at baseline.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JZP258
    Investigational medicinal product code
    Other name
    mixed oxybate salts; calcium, magnesium, potassium, sodium oxybate; Xywav
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Participants continued on their optimized stable dose.

    Number of subjects in period 2
    		On Baseline IH Medication Treatment Naive
    Started
    71
    52
    Completed
    69
    50
    Not completed
    2
    2
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    -
    2
         Lack of efficacy
    1
    -
    Period 3
    Period 3 title
    Double Blind Randomized-Withdrawal
    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
    		 On Baseline IH Medication
    Arm description
    		 Participants treated with medication for IH at baseline.
    Arm type
    		 Experimental versus Placebo

    Investigational medicinal product name
    JZP-258
    Investigational medicinal product code
    Other name
    mixed oxybate salts; calcium, magnesium, potassium, sodium oxybate; Xywav
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized 1:1 to continue their same dose of JZP-258 or placebo.

    Arm title
    		 Treatment Naive
    Arm description
    		 Participants not treated with medication for IH at baseline.
    Arm type
    		 Experimental versus Placebo

    Investigational medicinal product name
    JZP258
    Investigational medicinal product code
    Other name
    mixed oxybate salts; calcium, magnesium, potassium, sodium oxybate; Xywav
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized 1:1 to continue their same dose of JZP-258 or placebo.

    Number of subjects in period 3
    		On Baseline IH Medication Treatment Naive
    Started
    69
    47
    Completed
    67
    46
    Not completed
    2
    1
         Failure to meet randomization criteria
    1
    -
         Adverse event, non-fatal
    1
    1
    Period 4
    Period 4 title
    Open-Label Safety Extension
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 On Baseline IH Medication
    Arm description
    		 Participants treated with medication for IH at baseline.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JZP-258
    Investigational medicinal product code
    Other name
    mixed oxybate salts; calcium, magnesium, potassium, sodium oxybate; Xywav
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    All participants were treated with JZP-258.

    Arm title
    		 Treatment Naive
    Arm description
    		 Participants not treated with medication for IH at baseline.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JZP258
    Investigational medicinal product code
    Other name
    mixed oxybate salts; calcium, magnesium, potassium, sodium oxybate; Xywav
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    All participants were treated with JZP-258

    Number of subjects in period 4 [1]
    		On Baseline IH Medication Treatment Naive
    Started
    65
    41
    Completed
    57
    38
    Not completed
    8
    3
         Consent withdrawn by subject
    2
    3
         Adverse event, non-fatal
    3
    -
         Lost to follow-up
    1
    -
         Lack of efficacy
    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: To best evaluate safety with the DBRW design, we use the safety observations from all of the time frames in which patients were treated with JZP-258. These time frames are: the Open-label Treatment Titration and Optimization Period, the Stable Dose Period, the Double-blind Randomized Withdrawal Period, and the Open-label Safety Extension Period. Safety was evaluated in two groups (“Receiving Baseline IH Medication”, and “Naïve”).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    On Baseline IH Medication
    Reporting group description
    		 Participants treated with medication for IH at baseline.

    Reporting group title
    Treatment Naive
    Reporting group description
    		 Participants not treated with medication for IH at baseline.

    Reporting group values
    		 On Baseline IH Medication Treatment Naive Total
    Number of subjects
    		 88 66 154
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.0 ( 13.37 ) 39.4 ( 14.25 ) -
    Gender categorical
    Units: Subjects
        Female
    		 65 40 105
        Male
    		 23 26 49
    Subject analysis sets

    Subject analysis set title
    JZP-258
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified Intent to Treat (mITT) analysis set included all participants who were randomized to JZP258 or placebo, who received at least 1 dose of study drug during the DBRW and have had at least one set of post randomization assessments for ESS or IHSS, or a PGIc value at the end of the DBRW.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified Intent to Treat (mITT) analysis set included all participants who were randomized to JZP258 or placebo, who received at least 1 dose of study drug during the DBRW and have had at least one set of post randomization assessments for ESS or IHSS, or a PGIc value at the end of the DBRW.

    Subject analysis sets values
    		 JZP-258 Placebo
    Number of subjects
    56
    59
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.4 ( 14.44 )
    38.5 ( 13.01 )
    Gender categorical
    Units: Subjects
        Female
    39
    43
        Male
    17
    16

    End points

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    End points reporting groups
    Reporting group title
    On Baseline IH Medication
    Reporting group description
    		 Participants treated with medication for IH at baseline.

    Reporting group title
    Treatment Naive
    Reporting group description
    		 Participants not treated with medication for IH at baseline.
    Reporting group title
    On Baseline IH Medication
    Reporting group description
    		 Participants treated with medication for IH at baseline.

    Reporting group title
    Treatment Naive
    Reporting group description
    		 Participants not treated with medication for IH at baseline.
    Reporting group title
    On Baseline IH Medication
    Reporting group description
    		 Participants treated with medication for IH at baseline.

    Reporting group title
    Treatment Naive
    Reporting group description
    		 Participants not treated with medication for IH at baseline.
    Reporting group title
    On Baseline IH Medication
    Reporting group description
    		 Participants treated with medication for IH at baseline.

    Reporting group title
    Treatment Naive
    Reporting group description
    		 Participants not treated with medication for IH at baseline.

    Subject analysis set title
    JZP-258
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified Intent to Treat (mITT) analysis set included all participants who were randomized to JZP258 or placebo, who received at least 1 dose of study drug during the DBRW and have had at least one set of post randomization assessments for ESS or IHSS, or a PGIc value at the end of the DBRW.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified Intent to Treat (mITT) analysis set included all participants who were randomized to JZP258 or placebo, who received at least 1 dose of study drug during the DBRW and have had at least one set of post randomization assessments for ESS or IHSS, or a PGIc value at the end of the DBRW.

    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
    The ESS is a 8-item self reported questionnaire intended to measure daytime sleepiness. In this test, participants answer questions with regard to the level of sleepiness they experienced over approximately the 7 days prior to the assessment while performing eight common, non-stimulating activities. The ESS total score range is 1 to 24. Each activity is rated on a 4-point scale ranging from a minimum of "would never doze" to a maximum of "a high chance of dozing." Thus, the ESS scale range is as follows: 0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing; 0 indicates a better outcome, and 3 indicates a worse outcome. A positive mean change value indicates an increase in score from the end of the stable dose period and worsened daytime sleepiness. A higher ESS score (above 10) reflects a greater average sleep propensity in daily life (ASP) , or daytime sleepiness.
    End point type
    Primary
    End point timeframe
    Change from the end of the Stable Dose Period to the end of the Double-blind Randomized Withdrawal Period (DBRW) (2 Weeks)
    End point values
    		 JZP-258 Placebo
    Number of subjects analysed
    56
    59
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.7 ( 3.22 )
    7.4 ( 5.16 )
    Statistical analysis title
    		 Change from Baseline in ESS Score
    Comparison groups
    JZP-258 v Placebo
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -6.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.99
         upper limit
    		 -5.03
    Notes
    [1] - Mixed model analysis of covariance to compare treatment groups, with the change in ESS total score from the end of the SDP to the end of DBRWP as the response variable, with fixed effects of treatment group and baseline medication group and covariate of ESS total score at the end of the SDP.

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

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    End point title
    		 Percentage of Participants Reported as Worse on the Patient Global Impression of Change (PGIc)
    End point description
    The Patient Global Impression - Change (PGIc) scale was completed by the participant. The PGI-C scale rated the participant's condition at a specified time point on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse." The PGIc scale consists of the following ratings: 1-Very Much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse; a rating of 1 indicates a better outcome, and a rating of 7 indicates a worse outcome. Worsened condition was defined as a PGIc rating of 5, 6, or 7.
    End point type
    Secondary
    End point timeframe
    At the end of the DBRW Period (2 Weeks)
    End point values
    		 JZP-258 Placebo
    Number of subjects analysed
    56
    59
    Units: percentage of participants
    12
    52
    Statistical analysis title
    		 Participants who worsen in PGIc in DBWP
    Comparison groups
    JZP-258 v Placebo
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Proportion
    Point estimate
    -0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 -0.53
    Notes
    [2] - Cochran-Mantel-Haenszel test, stratified by baseline medication group, to compare the difference between treatment groups in the proportion of participants who worsen (very much worse, much worse, minimally worse) in the PGIc assessment at the end of DBRWP.

    Secondary: Change in Total Score on the Idiopathic Hypersomnia Severity Scale (IHSS)

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    End point title
    		 Change in Total Score on the Idiopathic Hypersomnia Severity Scale (IHSS)
    End point description
    The IHSS is a 14-item self-reported questionnaire assessing the severity of IH symptoms of excessive sleepiness, prolonged sleep duration, cognitive impairment and sleep inertia. Total scores can range from 0 to 50, with higher scores indicating a greater severity or frequency of symptoms.
    End point type
    Secondary
    End point timeframe
    Change from the end of the Stable Dose Period to the end of the DBRW Period (2 Weeks)
    End point values
    		 JZP-258 Placebo
    Number of subjects analysed
    56
    59
    Units: score on a scale
        median (full range (min-max))
    0.0 (-8 to 24)
    14.0 (-2 to 38)
    Statistical analysis title
    		 Change from Baseline in IHSS score
    Comparison groups
    Placebo v JZP-258
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Median difference (final values)
    Point estimate
    -12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15
         upper limit
    		 -8
    Notes
    [3] - The estimated median difference between treatment groups are obtained from a Hodges-Lehmann estimate. The p-value is obtained from a rank based, mixed-model analysis of covariance to compare treatment groups, with the change in IHSS total score from the end of the SDP to the end of DBRWP as the response variable, with fixed effects of treatment group and baseline medication group and covariate of ranked IHSS total score at the end of the SDP.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the time on or after the first dose of study drug, including adverse events that occurred until 30 days after the last dose date up to 42 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    On Baseline IH Medication
    Reporting group description
    		 Participants treated with medication for IH at baseline.

    Reporting group title
    Treatment Naive
    Reporting group description
    		 Participants not treated with medication for IH at baseline.

    Serious adverse events
    		 On Baseline IH Medication Treatment Naive
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 66 (3.03%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 66 (1.52%)
         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
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rhabdomyolysis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pyelonephritis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 66 (1.52%)
         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
    		 On Baseline IH Medication Treatment Naive
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    64 / 88 (72.73%)
    39 / 66 (59.09%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    5 / 88 (5.68%)
    1 / 66 (1.52%)
         occurrences all number
    5
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    8 / 88 (9.09%)
    11 / 66 (16.67%)
         occurrences all number
    8
    11
    Headache
         subjects affected / exposed
    15 / 88 (17.05%)
    12 / 66 (18.18%)
         occurrences all number
    26
    16
    Paraesthesia
         subjects affected / exposed
    5 / 88 (5.68%)
    0 / 66 (0.00%)
         occurrences all number
    5
    0
    Somnolence
         subjects affected / exposed
    5 / 88 (5.68%)
    4 / 66 (6.06%)
         occurrences all number
    6
    5
    Tremor
         subjects affected / exposed
    9 / 88 (10.23%)
    0 / 66 (0.00%)
         occurrences all number
    11
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 88 (9.09%)
    4 / 66 (6.06%)
         occurrences all number
    10
    5
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    5 / 88 (5.68%)
    1 / 66 (1.52%)
         occurrences all number
    5
    1
    Diarrhoea
         subjects affected / exposed
    11 / 88 (12.50%)
    3 / 66 (4.55%)
         occurrences all number
    15
    4
    Dry mouth
         subjects affected / exposed
    8 / 88 (9.09%)
    2 / 66 (3.03%)
         occurrences all number
    8
    2
    Nausea
         subjects affected / exposed
    21 / 88 (23.86%)
    13 / 66 (19.70%)
         occurrences all number
    31
    14
    Vomiting
         subjects affected / exposed
    15 / 88 (17.05%)
    3 / 66 (4.55%)
         occurrences all number
    18
    3
    Respiratory, thoracic and mediastinal disorders
    Snoring
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 66 (6.06%)
         occurrences all number
    1
    5
    Skin and subcutaneous tissue disorders
    Night sweats
         subjects affected / exposed
    7 / 88 (7.95%)
    2 / 66 (3.03%)
         occurrences all number
    10
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    10 / 88 (11.36%)
    8 / 66 (12.12%)
         occurrences all number
    11
    8
    Insomnia
         subjects affected / exposed
    13 / 88 (14.77%)
    4 / 66 (6.06%)
         occurrences all number
    15
    4
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 88 (5.68%)
    2 / 66 (3.03%)
         occurrences all number
    6
    3
    Muscle spasms
         subjects affected / exposed
    7 / 88 (7.95%)
    1 / 66 (1.52%)
         occurrences all number
    9
    1
    Pain in extremity
         subjects affected / exposed
    6 / 88 (6.82%)
    0 / 66 (0.00%)
         occurrences all number
    6
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 88 (6.82%)
    6 / 66 (9.09%)
         occurrences all number
    6
    7
    Sinusitis
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 66 (6.06%)
         occurrences all number
    1
    5
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 88 (7.95%)
    5 / 66 (7.58%)
         occurrences all number
    7
    6
    Urinary tract infection
         subjects affected / exposed
    6 / 88 (6.82%)
    6 / 66 (9.09%)
         occurrences all number
    7
    7
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    7 / 88 (7.95%)
    7 / 66 (10.61%)
         occurrences all number
    7
    7

    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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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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