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    Clinical Trial Results:
    Pharmaco-EEG for Montelukast. Can we detect neural changes during medication with Montelukast in the EEG?

    Summary
    EudraCT number
    		 2016-003061-25
    Trial protocol
    		 AT  
    Global end of trial date
    30 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jan 2020
    First version publication date
    02 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MPEEG_2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Neurology, Christian Doppler Medical Center, Paracelsus Medical University Salzburg
    Sponsor organisation address
    Ignaz-Harrer-Str. 79, Salzburg, Austria, 5020
    Public contact
    Principal Investigator, Department of Neurology, Christian Doppler Medical Center, Paracelsus Medical University Salzburg, w.staffen@salk.at
    Scientific contact
    Principal Investigator, Department of Neurology, Christian Doppler Medical Center, Paracelsus Medical University Salzburg, w.staffen@salk.at
    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
    Interim
    Date of interim/final analysis
    11 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We aimed to examine effects of Montelukast on brain activity.
    Protection of trial subjects
    Participants were treated with Montelukast per indication, the trial added only examination with psychological tests and the electroencephalogram. Both of these examinations are free of distress and pain.
    Background therapy
    		 No background therapy was used.
    Evidence for comparator
    		 No comparators were used.
    Actual start date of recruitment
    02 Jan 2017
    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
    Austria: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    10
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from begin of trial until 8 weeks before end of trial by Pulmonologists in Salzburg.

    Pre-assignment
    Screening details
    		 When a pulmonologist in Salzburg prescribed Montelukast to the patient, he informed the patient in written and oral form about the trial. If the patient was interested, he/she could choose whether he would give the doctor the informed consent to forward his contact information to the study team or whether he would like to contact the study team.

    Period 1
    Period 1 title
    overall trial - baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding was implemented. Patients received treatment according to indication.

    Arms
    Arm title
    		 All participants
    Arm description
    		 There was only one arm in the study.
    Arm type
    		 Observation

    Investigational medicinal product name
    Singulair
    Investigational medicinal product code
    PR1
    Other name
    Montelukast
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment is not specified by the protocol; the medical doctor decides on the treatment. The trial observed cognitive/brain changes during this treatment over 8 weeks. Treatment is likely to be continued after participation of the patient in this trial.

    Number of subjects in period 1
    		All participants
    Started
    13
    Completed
    13
    Period 2
    Period 2 title
    overall trial - 8 weeks follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding was done.

    Arms
    Arm title
    		 All participants
    Arm description
    		 There was only one arm in the study.
    Arm type
    		 Observation

    Investigational medicinal product name
    Singulair
    Investigational medicinal product code
    PR1
    Other name
    Montelukast
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment is not specified by the protocol; the medical doctor decides on the treatment. The trial observed cognitive/brain changes during this treatment over 8 weeks. Treatment is likely to be continued after participation of the patient in this trial.

    Number of subjects in period 2
    		All participants
    Started
    13
    Completed
    12
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial - baseline
    Reporting group description
    		 -

    Reporting group values
    		 overall trial - baseline Total
    Number of subjects
    		 13 13
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 5 5
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 53.38 (20 to 73) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 3 3
    Handedness
    Units: Subjects
        right
    		 13 13
        left
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 There was only one arm in the study.
    Reporting group title
    All participants
    Reporting group description
    		 There was only one arm in the study.

    Primary: EEG-characteristics - brainrate

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    End point title
    		 EEG-characteristics - brainrate
    End point description
    Differences in EEG characteristics (brainrate) between baseline (before treatment) and follow up (after 8 weeks of treatment).
    End point type
    Primary
    End point timeframe
    from baseline to after 8 weeks of treatment
    End point values
    		 All participants All participants
    Number of subjects analysed
    7
    7
    Units: brainrate
        arithmetic mean (standard deviation)
    7.766 ( 0.3475 )
    8.0798 ( 0.3248 )
    Statistical analysis title
    		 EEG brainrate comparison
    Comparison groups
    All participants v All participants
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.0313 [2]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3138
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.73
         upper limit
    		 0.1
    Variability estimate
    Standard deviation
    Dispersion value
    0.25
    Notes
    [1] - pre- to post treatment comparison
    [2] - signed rank=1

    Primary: EEG characteristics - Hjorth activity

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    End point title
    		 EEG characteristics - Hjorth activity
    End point description
    End point type
    Primary
    End point timeframe
    baseline to after 8 weeks of treatment
    End point values
    		 All participants All participants
    Number of subjects analysed
    7
    7
    Units: activity
        arithmetic mean (standard deviation)
    127.8879 ( 41.9411 )
    126.1421 ( 124.5285 )
    Statistical analysis title
    		 EEG Hjorth activity comparison
    Comparison groups
    All participants v All participants
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.375 [4]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.7458
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -219.07
         upper limit
    		 222.57
    Variability estimate
    Standard deviation
    Dispersion value
    134.24
    Notes
    [3] - pre- to post treatment comparison
    [4] - signed rank=20

    Primary: EEG characteristics - Hjorth mobility

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    End point title
    		 EEG characteristics - Hjorth mobility
    End point description
    End point type
    Primary
    End point timeframe
    baseline to after 8 weeks of treatment
    End point values
    		 All participants All participants
    Number of subjects analysed
    7
    7
    Units: mobility index
        arithmetic mean (standard deviation)
    0.6128 ( 0.1385 )
    0.6379 ( 0.1078 )
    Statistical analysis title
    		 EEG Hjorth mobility comparison
    Comparison groups
    All participants v All participants
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.4688 [6]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.0252
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.1558
         upper limit
    		 0.1055
    Variability estimate
    Standard deviation
    Dispersion value
    0.0794
    Notes
    [5] - pre- to post treatment comparison
    [6] - signed rank=9

    Primary: EEG characteristics: alpha power

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    End point title
    		 EEG characteristics: alpha power
    End point description
    End point type
    Primary
    End point timeframe
    baseline to after 8 weeks of treatment
    End point values
    		 All participants All participants
    Number of subjects analysed
    7
    7
    Units: micro Volt
        arithmetic mean (standard deviation)
    44.8017 ( 22.5384 )
    66.7682 ( 91.2418 )
    Statistical analysis title
    		 EEG alpha power comparison
    Comparison groups
    All participants v All participants
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.9375 [8]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -21.97
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -174.54
         upper limit
    		 130.61
    Variability estimate
    Standard deviation
    Dispersion value
    92.75
    Notes
    [7] - pre- to post treatment comparison
    [8] - signed rank=15

    Secondary: Psychological tests - Epitrack

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    End point title
    		 Psychological tests - Epitrack
    End point description
    Epitrack is a cognitive test battery, the score indicates perfomance in memory and attention.
    End point type
    Secondary
    End point timeframe
    after 8 weeks of treatment
    End point values
    		 All participants All participants
    Number of subjects analysed
    13
    12
    Units: score
        arithmetic mean (standard deviation)
    35.4615 ( 3.5435 )
    37 ( 3.6056 )
    Statistical analysis title
    		 Epitrack cognitive changes
    Statistical analysis description
    Analyze change on Epitrack test
    Comparison groups
    All participants v All participants
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 = 0.1816 [10]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.25
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -6.0138
         upper limit
    		 3.5138
    Variability estimate
    Standard deviation
    Dispersion value
    2.8959
    Notes
    [9] - pre- to post treatment comparison
    [10] - signed rank=13.5

    Secondary: Psychological tests - VLMT-learning

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    End point title
    		 Psychological tests - VLMT-learning
    End point description
    End point type
    Secondary
    End point timeframe
    before and after 8 weeks of treatment
    End point values
    		 All participants All participants
    Number of subjects analysed
    11
    8
    Units: score
        arithmetic mean (standard deviation)
    54.36 ( 9.33 )
    56.13 ( 8.75 )
    Statistical analysis title
    		 VLMT-learning comparison pre- to post-treatment
    Comparison groups
    All participants v All participants
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 = 0.25 [12]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.25
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -12.42
         upper limit
    		 5.92
    Variability estimate
    Standard deviation
    Dispersion value
    5.57
    Notes
    [11] - pre- to post-treatment comparison
    [12] - signed rand=6.5

    Secondary: Psychological tests - VLMT-consolidation

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    End point title
    		 Psychological tests - VLMT-consolidation
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to 8 weeks after treatment
    End point values
    		 All participants All participants
    Number of subjects analysed
    9
    8
    Units: score
        arithmetic mean (standard deviation)
    40.56 ( 8.38 )
    38.50 ( 8.97 )
    Statistical analysis title
    		 VLMT-consolidation comparison
    Comparison groups
    All participants v All participants
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    P-value
    		 = 1 [14]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.25
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -16.5998
         upper limit
    		 16.0998
    Variability estimate
    Standard deviation
    Dispersion value
    9.94
    Notes
    [13] - coparison pre- to post-treatment
    [14] - signed rank=10

    Secondary: Psychological tests - VLMT- recognition

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    End point title
    		 Psychological tests - VLMT- recognition
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to after 8 weeks of treatment
    End point values
    		 All participants All participants
    Number of subjects analysed
    8
    8
    Units: score
        arithmetic mean (standard deviation)
    43.88 ( 11.23 )
    43.38 ( 15.46 )
    Statistical analysis title
    		 VLMT-recognition comparison
    Comparison groups
    All participants v All participants
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    P-value
    		 = 1 [16]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -12.39
         upper limit
    		 13.39
    Variability estimate
    Standard deviation
    Dispersion value
    7.84
    Notes
    [15] - pre- to post treatment comparison
    [16] - signed rank=14

    Secondary: EEG-paradigm - Wordpair learning

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    End point title
    		 EEG-paradigm - Wordpair learning
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to 8 weeks post treatment
    End point values
    		 All participants All participants
    Number of subjects analysed
    10
    10
    Units: number of words remembered
        arithmetic mean (standard deviation)
    22.1 ( 10.514 )
    23.2 ( 13.1386 )
    Statistical analysis title
    		 Wordpair learning comparison
    Comparison groups
    All participants v All participants
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    P-value
    		 = 0.9698 [18]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.2246
         upper limit
    		 1.9754
    Variability estimate
    Standard deviation
    Dispersion value
    5.3219
    Notes
    [17] - pre- to post treatment comparison
    [18] - ranksum: 104, z-value -0.0378

    Secondary: EEG-paradigm - virtual reality task

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    End point title
    		 EEG-paradigm - virtual reality task
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to after 8 weeks of treatment
    End point values
    		 All participants All participants
    Number of subjects analysed
    13
    12
    Units: remembered items
        arithmetic mean (standard deviation)
    40.625 ( 9.5647 )
    42.1429 ( 13.1739 )
    Statistical analysis title
    		 Virtual reality task comparison
    Comparison groups
    All participants v All participants
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    P-value
    		 = 0.5801 [20]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.25
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -11.8
         upper limit
    		 14.3
    Variability estimate
    Standard deviation
    Dispersion value
    7.93
    Notes
    [19] - pre- to post treatment comparison
    [20] - signed rank 46.5

    Secondary: Psychological tests - TAP phasic alertness

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    End point title
    		 Psychological tests - TAP phasic alertness
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to after 8 weeks of treatment
    End point values
    		 All participants All participants
    Number of subjects analysed
    13
    12
    Units: T-value
        arithmetic mean (standard deviation)
    45.77 ( 9.27 )
    45.92 ( 5.48 )
    Statistical analysis title
    		 TAP comparison
    Comparison groups
    All participants v All participants
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other [21]
    P-value
    		 = 0.9531 [22]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.17
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -14.42
         upper limit
    		 14.09
    Variability estimate
    Standard deviation
    Dispersion value
    8.67
    Notes
    [21] - comparison of baseline to after 8 weeks of treatment
    [22] - signed rank=38

    Secondary: Psychological tests - FPZ

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    End point title
    		 Psychological tests - FPZ
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to after 8 weeks of treatment.
    End point values
    		 All participants All participants
    Number of subjects analysed
    13
    12
    Units: score
        arithmetic mean (standard deviation)
    220.98 ( 37.89 )
    219.98 ( 34.24 )
    Statistical analysis title
    		 FPZ pre- to post treatment comparison
    Comparison groups
    All participants v All participants
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other [23]
    P-value
    		 = 0.6904 [24]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.8367
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -31.67
         upper limit
    		 39.35
    Variability estimate
    Standard deviation
    Dispersion value
    21.586
    Notes
    [23] - pre- to post treatment comparison
    [24] - signed rank=44.5

    Secondary: Psychological tests - HADS depression

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    End point title
    		 Psychological tests - HADS depression
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to after 8 weeks of treatment
    End point values
    		 All participants All participants
    Number of subjects analysed
    13
    11
    Units: T-value
        arithmetic mean (standard deviation)
    49.75 ( 9.17 )
    49.74 ( 12.63 )
    Statistical analysis title
    		 HADS depression comparison
    Statistical analysis description
    Pre- to post treatment comparison of depression scores
    Comparison groups
    All participants v All participants
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6563 [25]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -7.67
         upper limit
    		 8.07
    Variability estimate
    Standard deviation
    Dispersion value
    4.78
    Notes
    [25] - signed rank =17

    Secondary: Psychological tests - HADS anxiety

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    End point title
    		 Psychological tests - HADS anxiety
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to after 8 weeks of treatment
    End point values
    		 All participants All participants
    Number of subjects analysed
    13
    11
    Units: T-value
        arithmetic mean (standard deviation)
    47.26 ( 12.87 )
    44.65 ( 12.22 )
    Statistical analysis title
    		 HADS anxiety comparison
    Comparison groups
    All participants v All participants
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other [26]
    P-value
    		 = 0.5781 [27]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.68
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -12.08
         upper limit
    		 15.45
    Variability estimate
    Standard deviation
    Dispersion value
    8.37
    Notes
    [26] - comparison of baseline to after 8 weeks of treatment
    [27] - signed rank=22.5

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Begin of trial until end of trial.
    Adverse event reporting additional description
    Participants were informed upon inclusion to immediately inform the medical doctor or the study team about adverse events.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 There was only one arm in the study.

    Serious adverse events
    		 All participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 13 (7.69%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    General disorders and administration site conditions
    Agitation
    Additional description: SOC: Behavioral disorders
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1

    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.
    Because recruitment was rather difficult, even after extending the trial two years resulted in a low number of subjects (12 instead of the aim of N=24). The analysis is thus likely underpowered.
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