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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, cross-over, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin and tapentadol on biomarkers of pain processing observed by Peripheral Nerve Excitability Testing (NET)

    Summary
    EudraCT number
    		 2019-000942-36
    Trial protocol
    		 BE   DK   IT  
    Global end of trial date
    25 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jul 2023
    First version publication date
    16 Jul 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IMI2-PainCare-BioPain-RCT1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 165, J109, Aarhus, Denmark, 8200
    Public contact
    Danish Pain Research Center, Aarhus University, 45 93508575, dprc@clin.au.dk
    Scientific contact
    Danish Pain Research Center, Aarhus University, 45 93508575, dprc@clin.au.dk
    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
    09 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    25 May 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    1. To test if the Strength Duration Time Constant (SDTC) changes (at planned first post-dose timing) of large sensory fibers differs in the lacosamide period as compared to the placebo period. 2. To test if the Strength Duration Time Constant (SDTC) changes (at planned first post-dose timing) of large motor fibers differs in the lacosamide period as compared to the placebo period.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the ICH Good Clinical Practice (GCP) guidelines. Local regulatory requirements were followed. Written informed consent was obtained from all subjects. The information interview was conducted in an office without disturbances and interruptions, and there was enough time to give information and discuss possible questions. The subjects were informed that their participation is voluntary, and that they can withdraw from the project at any time.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jul 2020
    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
    Belgium: 12
    Country: Number of subjects enrolled
    Denmark: 20
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Italy: 3
    Worldwide total number of subjects
    43
    EEA total number of subjects
    43
    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)
    43
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was performed from July 8, 2020 to February 4, 2022 at 4 centers in Denmark, Belgium, Germany, and Italy. The trial had to be terminated early due operational impact of the Covid-19 pandemic during the past 2 years and as the overall timelines of the project did not allow any further extension of the trial

    Pre-assignment
    Screening details
    		 We screened 66 subjects, of which 25 were screened in Denmark, 16 in Belgium, 21 in Germany and 4 in Italy. In total, 43 subjects were enrolled/randomized.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Lacosamide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    N03AX18,
    Other name
    vimpat
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    composition: 2x 100 mg lacosamide tablets. Single dose.

    Arm title
    		 Pregabalin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    pregabalin
    Investigational medicinal product code
    N03AX16
    Other name
    Lyrica
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2 x 75 mg pregabalin capsules, single dose.

    Arm title
    		 Tapentadol
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tapentadol
    Investigational medicinal product code
    N02AX06
    Other name
    Palexia
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2x 50 mg tapentadol immediate release tablet, single dose

    Arm title
    		 Placebo
    Arm description
    		 -
    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
    2 x hard gelatine capsules filled with mannitol and colloidal silicon dioxide (DAC - Deutscher Arzneimittel Codex). Single dose

    Number of subjects in period 1
    		Lacosamide Pregabalin Tapentadol Placebo
    Started
    41
    42
    41
    42
    Completed
    41
    41
    41
    41
    Not completed
    0
    1
    0
    1
         Received a positive COVID-19 test
    -
    -
    -
    1
         Protocol deviation
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall study (overall period) Total
    Number of subjects
    		 43 43
    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)
    		 43 43
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 25.4 ( 4.49 ) -
    Gender categorical
    Units: Subjects
        Female
    		 21 21
        Male
    		 22 22

    End points

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    End points reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    		 -

    Reporting group title
    Pregabalin
    Reporting group description
    		 -

    Reporting group title
    Tapentadol
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Co-primary: Changes of the Strength Duration Time Constant (SDTC) measured in large sensory fibers on the non-sensitized skin

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    End point title
    		 Co-primary: Changes of the Strength Duration Time Constant (SDTC) measured in large sensory fibers on the non-sensitized skin
    End point description
    This co-primary objective is to test if the SDTC changes (at planned first post-dose timing) of large sensory fibers differs in the lacosamide period as compared to the placebo period.
    End point type
    Primary
    End point timeframe
    The first measurement post dosing (i.e. around 1 hour after drug administration) relative to the pre-dose measurement (i.e. difference to period specific baseline)
    End point values
    		 Lacosamide Pregabalin Tapentadol Placebo
    Number of subjects analysed
    39
    37
    36
    38
    Units: ms
        arithmetic mean (standard deviation)
    -0.013 ( 0.078 )
    0.045 ( 0.079 )
    0.006 ( 0.090 )
    0.036 ( 0.089 )
    Statistical analysis title
    		 Co-primary outcome (sensory) (primary objective)
    Statistical analysis description
    Changes of the Strength Duration Time Constant (SDTC) measured in large sensory fibers on the non-sensitized skin
    Comparison groups
    Placebo v Lacosamide
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.012
    Method
    		 Mixed models for repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.044
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.077
         upper limit
    		 -0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.017
    Notes
    [1] - As this is a cross-over study, the subject in the analysis is not 77 but 38
    Statistical analysis title
    		 Co-primary outcome (sensory) (secondary objective)
    Statistical analysis description
    Changes of the Strength Duration Time Constant (SDTC) measured in large sensory fibers on the non-sensitized skin
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.32
    Method
    		 Mixed models for repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.017
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.017
         upper limit
    		 0.051
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.017
    Notes
    [2] - As this is a cross-over study, the subject in the analysis is not 75 but 37
    Statistical analysis title
    		 Co-primary outcome (sensory) (secondary objective)
    Statistical analysis description
    Changes of the Strength Duration Time Constant (SDTC) measured in large sensory fibers on the non-sensitized skin
    Comparison groups
    Tapentadol v Placebo
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.27
    Method
    		 Mixed models for repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.019
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.054
         upper limit
    		 0.015
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.017
    Notes
    [3] - As this is a cross-over study, the subject in the analysis is not 74 but 36

    Primary: Co-primary: Changes of the Strength Duration Time Constant (SDTC) measured in large motor fibers on the non-sensitized skin

    		 Close Top of page
    End point title
    		 Co-primary: Changes of the Strength Duration Time Constant (SDTC) measured in large motor fibers on the non-sensitized skin
    End point description
    End point type
    Primary
    End point timeframe
    At the planned first PD time point post dosing relative to their pre-dose PD measurement (i.e. difference to period specific baseline).
    End point values
    		 Lacosamide Pregabalin Tapentadol Placebo
    Number of subjects analysed
    40
    39
    39
    39
    Units: ms
        arithmetic mean (standard deviation)
    0.008 ( 0.067 )
    0.023 ( 0.092 )
    0.004 ( 0.12 )
    0.043 ( 0.076 )
    Statistical analysis title
    		 Co-primary outcome (motor) (primary objective)
    Comparison groups
    Lacosamide v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.062
    Method
    		 Mixed models for repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.034
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.002
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.018
    Notes
    [4] - Since this is a cross-over study the subjects in this analysis is not 79 but 39.
    Statistical analysis title
    		 Co-primary outcome (motor) (secondary objective)
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.27
    Method
    		 Mixed models for repeated measures
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.056
         upper limit
    		 0.016
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.018
    Notes
    [5] - As this is a cross-over study, the subject in the analysis is not 78 but 39
    Statistical analysis title
    		 Co-primary outcome (motor) (secondary objective)
    Comparison groups
    Tapentadol v Placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.12
    Method
    		 Mixed models for repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.028
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.064
         upper limit
    		 0.008
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.018
    Notes
    [6] - As this is a cross-over study, the subject in the analysis is not 78 but 39

    Secondary: Secondary: Changes of the Strength Duration Time Constant (SDTC) measured in small sensory fibers on the sensitized skin

    		 Close Top of page
    End point title
    		 Secondary: Changes of the Strength Duration Time Constant (SDTC) measured in small sensory fibers on the sensitized skin
    End point description
    End point type
    Secondary
    End point timeframe
    At the planned first PD time point post dosing relative to their pre-dose PD measurement (i.e. difference to period specific baseline).
    End point values
    		 Lacosamide Pregabalin Tapentadol Placebo
    Number of subjects analysed
    29
    30
    30
    34
    Units: ms
        arithmetic mean (standard deviation)
    0.036 ( 0.26 )
    -0.127 ( 0.24 )
    -0.039 ( 0.26 )
    -0.118 ( 0.31 )
    Statistical analysis title
    		 Secondary outcome (primary objective)
    Comparison groups
    Lacosamide v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.143
    Method
    		 Mixed models for repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.092
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.032
         upper limit
    		 0.217
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.063
    Notes
    [7] - Since this a cross-over study, the subjects in this analysis is not 63 but 29
    Statistical analysis title
    		 Secondary outcome (secondary objective)
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.65
    Method
    		 Mixed models for repeated measures
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.028
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.094
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.062
    Notes
    [8] - As this is a cross-over study, the subject in the analysis is not 64 but 30
    Statistical analysis title
    		 Secondary outcome (secondary objective)
    Comparison groups
    Tapentadol v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.7
    Method
    		 Mixed models for repeated measures
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.024
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.099
         upper limit
    		 0.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.062
    Notes
    [9] - As this is a cross-over study, the subject in the analysis is not 64 but 30

    Secondary: Secondary: Changes of the Strength Duration Time Constant (SDTC) measured in small sensory fibers on the non-sensitized skin

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    End point title
    		 Secondary: Changes of the Strength Duration Time Constant (SDTC) measured in small sensory fibers on the non-sensitized skin
    End point description
    End point type
    Secondary
    End point timeframe
    The first measurement post dosing (i.e. around 1 hour after drug administration) relative to the pre-dose measurement (i.e. difference to period specific baseline)
    End point values
    		 Lacosamide Pregabalin Tapentadol Placebo
    Number of subjects analysed
    33
    29
    32
    32
    Units: ms
        arithmetic mean (standard deviation)
    0.003 ( 0.27 )
    0.024 ( 0.24 )
    -0.004 ( 0.21 )
    -0.012 ( 0.27 )
    Statistical analysis title
    		 Secondary outcome (primary objective)
    Comparison groups
    Lacosamide v Placebo
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 = 0.68
    Method
    		 Mixed models for repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.019
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.073
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.047
    Notes
    [10] - Since this a cross-over study, the subjects in this analysis is not 65 but 33
    Statistical analysis title
    		 Secondary outcome (secondary objective)
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 = 0.77
    Method
    		 Mixed models for repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.014
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.109
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.048
    Notes
    [11] - As this is a cross-over study, the subject in the analysis is not 61 but 29
    Statistical analysis title
    		 Secondary outcome (secondary objective)
    Comparison groups
    Tapentadol v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    P-value
    		 = 0.92
    Method
    		 Mixed models for repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.005
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.088
         upper limit
    		 0.098
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.047
    Notes
    [12] - As this is a cross-over study, the subject in the analysis is not 64 but 32

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From study period 1 to 7-14 days after last study period
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    		 -

    Reporting group title
    Pregabalin
    Reporting group description
    		 -

    Reporting group title
    Tapentadol
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Lacosamide Pregabalin Tapentadol Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Lacosamide Pregabalin Tapentadol Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 41 (29.27%)
    20 / 42 (47.62%)
    30 / 41 (73.17%)
    3 / 42 (7.14%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 41 (7.32%)
    13 / 42 (30.95%)
    22 / 41 (53.66%)
    0 / 42 (0.00%)
         occurrences all number
    3
    13
    22
    0
    Cramp-fasciculation syndrome
    Additional description: Jaw cramp and muscle cramp
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 42 (4.76%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Somnolence
         subjects affected / exposed
    3 / 41 (7.32%)
    8 / 42 (19.05%)
    7 / 41 (17.07%)
    1 / 42 (2.38%)
         occurrences all number
    3
    8
    7
    1
    Headache
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 42 (4.76%)
    3 / 41 (7.32%)
    0 / 42 (0.00%)
         occurrences all number
    0
    2
    3
    0
    Hyperacusis
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypoaesthesia oral
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Balance disorder
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tremor
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Presyncope
    Additional description: Lightheadedness
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 42 (4.76%)
    2 / 41 (4.88%)
    0 / 42 (0.00%)
         occurrences all number
    1
    2
    2
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 41 (7.32%)
    7 / 42 (16.67%)
    7 / 41 (17.07%)
    2 / 42 (4.76%)
         occurrences all number
    3
    7
    7
    2
    Peripheral coldness
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye disorders
    Visual impairment
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Asthenopia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    5 / 41 (12.20%)
    0 / 42 (0.00%)
         occurrences all number
    0
    0
    5
    0
    Dry mouth
         subjects affected / exposed
    3 / 41 (7.32%)
    3 / 42 (7.14%)
    8 / 41 (19.51%)
    0 / 42 (0.00%)
         occurrences all number
    3
    3
    8
    0
    Nausea
         subjects affected / exposed
    5 / 41 (12.20%)
    2 / 42 (4.76%)
    7 / 41 (17.07%)
    0 / 42 (0.00%)
         occurrences all number
    5
    2
    7
    0
    Abdominal pain
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    3 / 41 (7.32%)
    0 / 42 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Psychiatric disorders
    Disturbance in attention
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    2 / 41 (4.88%)
    0 / 42 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Euphoric mood
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 42 (4.76%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences all number
    0
    2
    1
    0

    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.
    Intermittent interruptions due to COVID-19 lockdown
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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