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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, cross-over trial in healthy subjects to investigate the effects of lacosamide, pregabalin and tapentadol on biomarkers of pain processing observed by functional magnetic resonance imaging (FMRI) of the brain

    Summary
    EudraCT number
    2019-000908-15
    Trial protocol
    DK   FR  
    Global end of trial date
    27 Jun 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Dec 2024
    First version publication date
    07 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IMI2-PainCare-BioPain-RCT4
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Aarhus University
    Sponsor organisation address
    Aarhus University, Aarhus, Denmark,
    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
    26 Mar 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jun 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To test if the punctate evoked BOLD response in the posterior insula at 3 hours post-drug administration differs in pregabalin period as compared to the placebo period, at the sensitized leg. 2. To test if the resting state connectivity between SII and thalamus at 3 hours post-drug administration in the presence of sensitization differs in the pregabalin 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 Feb 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 16
    Country: Number of subjects enrolled
    Denmark: 9
    Country: Number of subjects enrolled
    France: 6
    Worldwide total number of subjects
    31
    EEA total number of subjects
    15
    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)
    31
    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 February 8, 2021 to June 27, 2022 at 3 centers in Denmark, France and the United Kingdom.

    Pre-assignment
    Screening details
    We screened 39 subjects, of which 20 were screened in the UK, 10 in Denmark, and 9 in France. In total, 31 subjects were enrolled/randomized and 29 completed the study.

    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
    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 75mg pregabalin capsules, single dose

    Arm title
    Lacosamide
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    N03AX18
    Other name
    Limpet
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2 x 100mg lacosamide capsules, single dose

    Arm title
    Tapentadol
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Tapentadol
    Investigational medicinal product code
    N02AX06
    Other name
    Alexia
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2 x 50mg tapentadol capsules, 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 - deutchser arzneimittel codex), single dose

    Number of subjects in period 1
    Pregabalin Lacosamide Tapentadol Placebo
    Started
    29
    29
    29
    29
    Completed
    29
    29
    28
    29
    Not completed
    0
    0
    1
    0
         Adverse event, non-fatal
    -
    -
    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
    31 31
    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)
    31 31
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    25.6 ( 4.03 ) -
    Gender categorical
    Units: Subjects
        Female
    9 9
        Male
    22 22

    End points

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

    Reporting group title
    Lacosamide
    Reporting group description
    -

    Reporting group title
    Tapentadol
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Primary: Primary endpoint 1: To test if the punctate evoked BOLD response in the posterior insula at 3 hours post-drug administration differs in pregabalin period as compared to the placebo period, at the sensitized leg.

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    End point title
    Primary endpoint 1: To test if the punctate evoked BOLD response in the posterior insula at 3 hours post-drug administration differs in pregabalin period as compared to the placebo period, at the sensitized leg.
    End point description
    End point type
    Primary
    End point timeframe
    The second measurement post dosing (i.e. around 3 hours after drug administration).
    End point values
    Pregabalin Lacosamide Tapentadol Placebo
    Number of subjects analysed
    29
    29
    28
    29
    Units: BOLD response
        arithmetic mean (standard deviation)
    0.251 ( 0.1353 )
    0.293 ( 0.1313 )
    0.268 ( 0.1436 )
    0.313 ( 0.1308 )
    Statistical analysis title
    Primary endpoint 1: Pregabalin vs. placebo
    Statistical analysis description
    To test if the punctate evoked BOLD response in the posterior insula at 3 hours post-drug administration differs in pregabalin period as compared to the placebo period, at the sensitized leg.
    Comparison groups
    Placebo v Pregabalin
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.134
    Method
    Mixed models with repeated measures
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.052
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.121
         upper limit
    0.016
    Notes
    [1] - Note: This is a crossover study so the number of subjects included is 29.
    Statistical analysis title
    Additional endpoint: Lacosamide vs placebo
    Comparison groups
    Lacosamide v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    = 0.566
    Method
    Mixed models for repeated measures
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.089
         upper limit
    0.049
    Notes
    [2] - Note: This is a crossover study so the number of subjects included is 29.
    Statistical analysis title
    Additional endpoint: Tapentadol vs placebo
    Comparison groups
    Tapentadol v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    = 0.05
    Method
    Mixed models with repeated measures
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.069
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.138
         upper limit
    0
    Notes
    [3] - Note: This is a crossover study so the number of subjects included is 29.

    Primary: Primary endpoint 2: To test if the resting state connectivity between SII and thalamus at 3 hours post-drug administration in the presence of sensitization differs in the pregabalin period as compared to the placebo period.

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    End point title
    Primary endpoint 2: To test if the resting state connectivity between SII and thalamus at 3 hours post-drug administration in the presence of sensitization differs in the pregabalin period as compared to the placebo period.
    End point description
    End point type
    Primary
    End point timeframe
    The second measurement post dosing (i.e. around 3 hours after drug administration).
    End point values
    Pregabalin Lacosamide Tapentadol Placebo
    Number of subjects analysed
    29
    29
    28
    29
    Units: Functional connectivity
        arithmetic mean (standard deviation)
    -0.6 ( 0.82 )
    -0.8 ( 0.72 )
    -0.7 ( 0.65 )
    -0.5 ( 0.55 )
    Statistical analysis title
    Primary endpoint 2: Pregabalin vs placebo
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    superiority [4]
    P-value
    = 0.458
    Method
    Mixed models with repeated measures
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.4
         upper limit
    0.2
    Notes
    [4] - Note: This is a crossover study so the number of subjects included is 29.
    Statistical analysis title
    Additional endpoint: Lacosamide vs placebo
    Comparison groups
    Lacosamide v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    superiority [5]
    P-value
    = 0.047
    Method
    Mixed models with repeated measures
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.7
         upper limit
    0
    Notes
    [5] - Note: This is a crossover study so the number of subjects included is 29.
    Statistical analysis title
    Additional endpoint: Tapentadol vs placebo
    Comparison groups
    Tapentadol v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    superiority [6]
    P-value
    = 0.236
    Method
    Mixed models with repeated measures
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.5
         upper limit
    0.1
    Notes
    [6] - Note: This is a crossover study so the number of subjects included is 29.

    Secondary: Secondary endpoint 1: To test if the punctate evoked BOLD response in the posterior insula at 1 hour post-drug administration differs in at least one analgesic treatment period as compared to the placebo period, at the sensitized leg.

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    End point title
    Secondary endpoint 1: To test if the punctate evoked BOLD response in the posterior insula at 1 hour post-drug administration differs in at least one analgesic treatment period as compared to the placebo period, at the sensitized leg.
    End point description
    End point type
    Secondary
    End point timeframe
    The first measurement post dosing (i.e. around 1 hour after drug administration).
    End point values
    Pregabalin Lacosamide Tapentadol Placebo
    Number of subjects analysed
    29
    28
    28
    29
    Units: BOLD response
        arithmetic mean (standard deviation)
    0.289 ( 0.2046 )
    0.321 ( 0.1928 )
    0.289 ( 0.1300 )
    0.364 ( 0.1519 )
    Statistical analysis title
    Secondary endpoint: Pregabalin vs placebo
    Statistical analysis description
    To test if the punctate evoked BOLD response in the posterior insula at 1 hour post-drug administration differs in at least one analgesic treatment period as compared to the placebo period, at the sensitized leg.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    superiority [7]
    P-value
    = 0.033
    Method
    Mixed models with repeated measures
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.075
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.143
         upper limit
    -0.006
    Notes
    [7] - Note: This is a crossover study so the number of subjects included is 29.
    Statistical analysis title
    Secondary endpoint: Lacosamide vs placebo
    Statistical analysis description
    To test if the punctate evoked BOLD response in the posterior insula at 1 hour post-drug administration differs in at least one analgesic treatment period as compared to the placebo period, at the sensitized leg.
    Comparison groups
    Lacosamide v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    superiority [8]
    P-value
    = 0.295
    Method
    Mixed models with repeated measures
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.037
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.106
         upper limit
    0.032
    Notes
    [8] - Note: This is a crossover study so the number of subjects included is 29.
    Statistical analysis title
    Secondary endpoint: Tapentadol vs placebo
    Comparison groups
    Tapentadol v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    superiority [9]
    P-value
    = 0.01
    Method
    Mixed models with repeated measures
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.092
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.161
         upper limit
    -0.023
    Notes
    [9] - Note: This is a crossover study so the number of subjects included is 29.

    Secondary: Secondary endpoint 2: To test if the resting state connectivity between SII and thalamus at 1 hour post-drug administration in the presence of sensitization differs in at least one analgesic treatment session as compared to the placebo session.

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    End point title
    Secondary endpoint 2: To test if the resting state connectivity between SII and thalamus at 1 hour post-drug administration in the presence of sensitization differs in at least one analgesic treatment session as compared to the placebo session.
    End point description
    End point type
    Secondary
    End point timeframe
    The first measurement post dosing (i.e. around 1 hour after drug administration).
    End point values
    Pregabalin Lacosamide Tapentadol Placebo
    Number of subjects analysed
    29
    28
    28
    29
    Units: Functional connectivity
        arithmetic mean (standard deviation)
    -0.5 ( 0.78 )
    -0.7 ( 0.81 )
    -0.6 ( 0.59 )
    -0.3 ( 0.74 )
    Statistical analysis title
    Secondary endpoint: Pregabalin vs placebo
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    superiority [10]
    P-value
    = 0.402
    Method
    Mixed models with repeated measures
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.5
         upper limit
    0.2
    Notes
    [10] - Note: This is a crossover study so the number of subjects included is 29.
    Statistical analysis title
    Secondary endpoint: Lacosamide vs placebo
    Comparison groups
    Lacosamide v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    superiority [11]
    P-value
    = 0.045
    Method
    Mixed models with repeated measures
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.7
         upper limit
    0
    Notes
    [11] - Note: This is a crossover study so the number of subjects included is 29.
    Statistical analysis title
    Secondary endpoint: Tapentadol vs placebo
    Comparison groups
    Tapentadol v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    superiority [12]
    P-value
    = 0.058
    Method
    Mixed models with repeated measures
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.6
         upper limit
    0
    Notes
    [12] - Note: This is a crossover study so the number of subjects included is 29.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From study period 1 to 7-14 days after the 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 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 29 (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
    5 / 29 (17.24%)
    5 / 29 (17.24%)
    11 / 29 (37.93%)
    4 / 29 (13.79%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 29 (6.90%)
    4 / 29 (13.79%)
    6 / 29 (20.69%)
    0 / 29 (0.00%)
         occurrences all number
    2
    4
    6
    0
    Somnolence
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
    3 / 29 (10.34%)
    1 / 29 (3.45%)
         occurrences all number
    1
    2
    3
    1
    Headache
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Presyncope
    Additional description: light headedness
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    3 / 29 (10.34%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    3
    1
    General disorders and administration site conditions
    Nausea
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    1
    Vomiting
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear and labyrinth disorders
    Paracusis
    Additional description: Auditory hallucination
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Tinnitus
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye disorders
    Diplopia
    Additional description: Double vision
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Nystagmus
    Additional description: Horizontal nystagmus
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Dry mouth
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    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.
    There were intermittent interruptions to data collection due to the COVID-19 pandemic, but these delays did not affect the overall study results or data analysis.
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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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