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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 non-invasive neurophysiological measurements of human spinal cord and brainstem activity

    Summary
    EudraCT number
    		 2019-000755-14
    Trial protocol
    		 BE   IT  
    Global end of trial date
    30 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Sep 2023
    First version publication date
    17 Sep 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IMI2-PainCare-BioPain-RCT2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sapienza University of Rome
    Sponsor organisation address
    viale dell'università 30, Rome, Italy,
    Public contact
    Department of Human Neurosciences, Sapienza University of Rome, +39 0649914758, andrea.truini@uniroma1.it
    Scientific contact
    Department of Human Neurosciences, Sapienza University of Rome, +39 0649914758, andrea.truini@uniroma1.it
    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
    19 Apr 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Apr 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    1. To test if the percentage reduction of RIII flexion reflex area 60 minutes post-drug administration differs in the tapentadol period as compared to the placebo period, at the sensitized limb 2. To test if the percentage reduction of N13 amplitude 60 minutes post-drug administration differs in the tapentadol period as compared to the placebo period, at the sensitized limb
    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
    16 Sep 2019
    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: 4
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Italy: 16
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    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 September 16, 2019 to February 4, 2022 at 4 centers in Belgium, Germany, and Italy. The trial had to be terminated early due operational impact of the Covid19 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
    		 Screening details: We screened 34 subjects, of which 16 were screened in Italy, 6 in Belgium, and 5 in Germany. In total, 24 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
    Other name
    Vimpat
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    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
    Other name
    Lyrica
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    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
    Other name
    Palexia
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and administration details: 2x 50 mg tapentadol immediate release tablet, single dose

    Arm title
    		 placebo
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    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
    24
    22
    23
    23
    Completed
    24
    22
    23
    23

    Baseline characteristics

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    Baseline characteristics 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
    		 -

    Reporting group values
    		 Lacosamide Pregabalin Tapentadol placebo Total
    Number of subjects
    		 24 22 23 23 24
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 24 22 23 23 24
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 27.1 ± 4.2 27.1 ± 4.2 27.1 ± 4.2 27.1 ± 4.2 -
    Gender categorical
    Units: Subjects
        Female
    		 14 13 13 14 14
        Male
    		 10 9 10 9 10
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    subjects in the ‘all enrolled set’ that have been randomized

    Subject analysis sets values
    		 Full Analysis Set
    Number of subjects
    24
    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)
    24
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    27.1 ± 4.2
    Gender categorical
    Units: Subjects
        Female
    14
        Male
    10

    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
    		 -

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    subjects in the ‘all enrolled set’ that have been randomized

    Primary: co-primary: percentage of change of the RIII area of the flexion reflex at the time point t60 post-drug administration vs the pre-drug time point, at the sensitized lower limb.

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    End point title
    		 co-primary: percentage of change of the RIII area of the flexion reflex at the time point t60 post-drug administration vs the pre-drug time point, at the sensitized lower limb.
    End point description
    To test if the percentage of change of the RIII area of the flexion reflex at the time point t60 post-drug administration vs the pre-drug time point, differs in the tapentadol period as compared to the placebo period, at the sensitized lower limb.
    End point type
    Primary
    End point timeframe
    The first measurement post dosing (i.e. around 1 hour after drug administration) relative to the predose measurement (i.e. difference to period specific baseline)
    End point values
    		 Lacosamide Pregabalin Tapentadol placebo
    Number of subjects analysed
    24
    22
    23
    23
    Units: area under the curve
        arithmetic mean (standard deviation)
    48.07 ± 255.61
    -11.42 ± 35.21
    -10.23 ± 80.11
    58.22 ± 290.74
    Statistical analysis title
    		 co-primary outcome
    Statistical analysis description
    To test if the percentage of change of the RIII area of the flexion reflex at the time point t60 post-drug administration vs the pre-drug time point, differs in the tapentadol period as compared to the placebo period, at the sensitized lower limb.
    Comparison groups
    Tapentadol v placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.047
    Method
    		 MMRM model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -79.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -157.93
         upper limit
    		 -1.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    39.61
    Notes
    [1] - The two co-primary endpoints are tested for their differences between the treatment arms Tapentadol versus Placebo. This is conducted in parallel, splitting the overall α equally between the endpoint tests, i.e. each test has a Type I error of α/2 (0.05/2=0.025). Since it is a cross-over study, subjects in the analysis are 23 and not 46.
    Statistical analysis title
    		 co-primary outcome (secondary objective)
    Statistical analysis description
    To test if the percentage of change of the RIII area of the flexion reflex at the time point t60 post-drug administration vs the pre-drug time point, differs in the lacosamide period as compared to the placebo period, at the sensitized lower limb.
    Comparison groups
    Lacosamide v placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.62
    Method
    		 MMRM model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -19.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -96.98
         upper limit
    		 58.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    39.16
    Notes
    [2] - Since it is a cross-over study, subjects in the analysis are 23 and not 47
    Statistical analysis title
    		 co-primary outcome (secondary objective)
    Statistical analysis description
    To test if the percentage of change of the RIII area of the flexion reflex at the time point t60 post-drug administration vs the pre-drug time point, differs in the pregabalin period as compared to the placebo period, at the sensitized lower limb.
    Comparison groups
    placebo v Pregabalin
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.072
    Method
    		 MMRM model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -73.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -153.52
         upper limit
    		 6.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    40.49
    Notes
    [3] - Since it is a cross-over study, subjects in the analysis are 23 and not 45

    Primary: co-primary: percentage of change of the N13-SEP amplitude at the time point t60 post-drug administration vs the pre-drug time point, at the sensitized upper arm.

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    End point title
    		 co-primary: percentage of change of the N13-SEP amplitude at the time point t60 post-drug administration vs the pre-drug time point, at the sensitized upper arm.
    End point description
    To test if the percentage of change of the N13-SEP amplitude at the time point t60 post-drug administration vs the pre-drug time point, differs in the tapentadol period as compared to the placebo period, at the sensitized upper arm.
    End point type
    Primary
    End point timeframe
    The first measurement post dosing (i.e. around 1 hour after drug administration) relative to the predose measurement (i.e. difference to period specific baseline)
    End point values
    		 Lacosamide Pregabalin Tapentadol placebo
    Number of subjects analysed
    24
    22
    22 [4]
    23
    Units: amplitude microvolts
        arithmetic mean (standard deviation)
    -12.38 ± 44.9
    -10.45 ± 33.26
    19.12 ± 69.37
    6.78 ± 62.15
    Notes
    [4] - Change values. PD values were only available for 22 at both baseline and first postdose PD
    Statistical analysis title
    		 co-primary outcome
    Statistical analysis description
    To test if the percentage of change of the N13-SEP amplitude at the time point t60 post-drug administration vs the pre-drug time point, differs in the tapentadol period as compared to the placebo period, at the sensitized upper arm.
    Comparison groups
    Tapentadol v placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.92
    Method
    		 MMRM model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32.21
         upper limit
    		 35.65
    Variability estimate
    Standard deviation
    Dispersion value
    17.15
    Notes
    [5] - The two co-primary endpoints are tested for their differences between the treatment arms Tapentadol versus Placebo. This is conducted in parallel, splitting the overall α equally between the endpoint tests, i.e. each test has a Type I error of α/2 (0.05/2=0.025). Since it is a cross-over study, subjects in the analysis are 23 and not 45.
    Statistical analysis title
    		 co-primary outcome (secondary objective)
    Statistical analysis description
    To test if the percentage of change of the N13-SEP amplitude at the time point t60 post-drug administration vs the pre-drug time point, differs in the lacosamide period as compared to the placebo period, at the sensitized upper arm.
    Comparison groups
    placebo v Lacosamide
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.139
    Method
    		 MMRM model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -58.18
         upper limit
    		 8.19
    Variability estimate
    Standard deviation
    Dispersion value
    16.77
    Notes
    [6] - Since it is a cross-over study, subjects in the analysis are 23 and not 47
    Statistical analysis title
    		 co-primary outcome (secondary objective)
    Statistical analysis description
    To test if the percentage of change of the N13-SEP amplitude at the time point t60 post-drug administration vs the pre-drug time point, differs in the pregabalin period as compared to the placebo period, at the sensitized upper arm.
    Comparison groups
    placebo v Pregabalin
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.27
    Method
    		 MMRM model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -52.92
         upper limit
    		 14.91
    Variability estimate
    Standard deviation
    Dispersion value
    17.14
    Notes
    [7] - Since it is a cross-over study, subjects in the analysis are 23 and not 45.

    Secondary: key secondary analysis:percentage of change of the R2 recovery cycle at 500 ms interstimulus time interval at the time point T60 post-drug administration

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    End point title
    		 key secondary analysis:percentage of change of the R2 recovery cycle at 500 ms interstimulus time interval at the time point T60 post-drug administration
    End point description
    To test if the percentage of change of the R2 recovery cycle at 500 ms interstimulus time interval at the time point T60 post-drug administration vs the pre-drug administration differs in the tapentadol, pregabalin and/or lacosamide periods as compared to the placebo period.
    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
    24
    22
    23
    23
    Units: % change AUC
        arithmetic mean (standard deviation)
    34.4 ± 66.5
    -2.7 ± 68.04
    5 ± 35.18
    11.4 ± 42.7
    Statistical analysis title
    		 Key secondary endpoint
    Statistical analysis description
    To test if the percentage of change of the R2 recovery cycle at 500 ms interstimulus time interval at the time point T60 post-drug administration vs the pre-drug administration differs in the tapentadol, pregabalin and/or lacosamide periods as compared to the placebo period.
    Comparison groups
    Lacosamide v placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.527
    Method
    		 MMRM model
    Parameter type
    		 Median difference (final values)
    Point estimate
    9.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21
         upper limit
    		 40.8
    Variability estimate
    Standard deviation
    Dispersion value
    15.61
    Notes
    [8] - Since it is a cross-over study, subjects in the analysis are 23 and not 47
    Statistical analysis title
    		 Key secondary endpoint
    Statistical analysis description
    To test if the percentage of change of the R2 recovery cycle at 500 ms interstimulus time interval at the time point T60 post-drug administration vs the pre-drug administration differs in the tapentadol, pregabalin and/or lacosamide periods as compared to the placebo period.
    Comparison groups
    placebo v Pregabalin
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.131
    Method
    		 MMRM model
    Parameter type
    		 Median difference (final values)
    Point estimate
    -24.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -55.5
         upper limit
    		 7.3
    Variability estimate
    Standard deviation
    Dispersion value
    15.87
    Notes
    [9] - Since it is a cross-over study, subjects in the analysis are 23 and not 45.
    Statistical analysis title
    		 Key secondary endpoint
    Statistical analysis description
    To test if the percentage of change of the R2 recovery cycle at 500 ms interstimulus time interval at the time point T60 post-drug administration vs the pre-drug administration differs in the tapentadol, pregabalin and/or lacosamide periods as compared to the placebo period.
    Comparison groups
    placebo v Tapentadol
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 = 0.546
    Method
    		 MMRM model
    Parameter type
    		 Median difference (final values)
    Point estimate
    -9.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.6
         upper limit
    		 21.6
    Variability estimate
    Standard deviation
    Dispersion value
    15.71
    Notes
    [10] - Since it is a cross-over study, subjects in the analysis are 23 and not 46.

    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 / 24 (0.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    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
    0 / 24 (0.00%)
    4 / 22 (18.18%)
    5 / 22 (22.73%)
    1 / 23 (4.35%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 22 (9.09%)
    3 / 22 (13.64%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Somnolence
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Headache
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 22 (9.09%)
    1 / 22 (4.55%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    1
    1
    General disorders and administration site conditions
    sweating
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fatigue
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 22 (4.55%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    2
    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 and regulations

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36064434
    http://www.ncbi.nlm.nih.gov/pubmed/34756635
    http://www.ncbi.nlm.nih.gov/pubmed/34715423
    http://www.ncbi.nlm.nih.gov/pubmed/34675309
    http://www.ncbi.nlm.nih.gov/pubmed/33759294
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