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    Clinical Trial Results:
    Proof of effectiveness of Pascoflair using qantitative measurement of electric brain activity during examination stress in 40 subjects suffering from test anxiety. A double-blind, randomized, placebo-controlled, 2-armed, Phase IV study in parallel design.

    Summary
    EudraCT number
    		 2014-003369-50
    Trial protocol
    		 DE  
    Global end of trial date
    20 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Apr 2022
    First version publication date
    28 Apr 2022
    Other versions
    Summary report(s)
    		 Dimpfel et al. 2016
    Summary for German Authorities

    Trial information

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    Trial identification
    Sponsor protocol code
    200S14PF
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pascoe pharmazeutische Präparate
    Sponsor organisation address
    Schiffenberger Weg 55, Giessen, Germany, 35394
    Public contact
    Klinische Forschung H. Michels, PASCOE pharmazeutische Präparate GmbH, 0049 641-796-0958, holger.michels@pascoe.de
    Scientific contact
    Klinische Forschung H. Michels, PASCOE pharmazeutische Präparate GmbH, 6417960963 641-7960-958, holger.michels@pascoe.de
    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
    18 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Anxiolytic effects of PASCOFLAIR® shall be tested in subjects suffering from test anxiety after single intake by aid of a newly developed, validated method consisting of a combination of eye tracking (following glances) with neurocode tracking (quantitative EEG with a time resolution of 364 ms).
    Protection of trial subjects
    The only measure in this trial with a potential risk for the participants was blood sampling, where e.g. pain, bruises, hematoma, injury of nerves or infections may occur. No adverse events due to the blood sampling occured. Further risks due to the trial design or trial measures were not expected.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 2015
    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
    Germany: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    40
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Germany: May 2015 - Aug 2015: 40 subjects were randomized and received treatment (20x verum and 20x placebo)

    Pre-assignment
    Screening details
    		 During recruitment 9 people dropped out before randomized: 7 people "were no longer interested in or had no time for participating in the study" and 2 people were excluded due to "taking medications (exclusion criterion)"

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum
    Arm description
    		 subject received 2 tbl once
    Arm type
    		 Experimental

    Investigational medicinal product name
    PASCOFLAIR®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    single dose of 2 tbl

    Arm title
    		 Placebo
    Arm description
    		 subject received 2 tbl once
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    single dose of 2 tbl

    Number of subjects in period 1
    		Verum Placebo
    Started
    20
    20
    Completed
    20
    20

    Baseline characteristics

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

    Reporting group values
    		 Treatment (overall period) Total
    Number of subjects
    		 40 40
    Age categorical
    Adults (18-64 years)
    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)
    		 40 40
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Age - total
    Units: years
        arithmetic mean (standard deviation)
    		 25.75 ( 5.94 ) -
    Gender categorical
    Units: Subjects
        Female
    		 23 23
        Male
    		 17 17

    End points

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    End points reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 subject received 2 tbl once

    Reporting group title
    Placebo
    Reporting group description
    		 subject received 2 tbl once

    Primary: Effect of Placebo or Verum on spectral beta1 power

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    End point title
    		 Effect of Placebo or Verum on spectral beta1 power
    End point description
    Effect of Placebo or Verum on spectral beta1 power averaged including either all or selected electrode positions given on the right upper side. Data are given as % of baseline (ref) before intake. Statistical significance (Wilcoxon-Test) in comparison to Placebo is documented by stars: *=p<0.10; **=p<0.05.
    End point type
    Primary
    End point timeframe
    About 45 minutes after intake of study medication
    End point values
    		 Verum Placebo
    Number of subjects analysed
    20
    20
    Units: percent
        number (not applicable)
    20
    20
    Attachments
    		 verum vs. placebo beta1
    Statistical analysis title
    		 Wilcoxon test
    Statistical analysis description
    For explorative statistical evaluation the nonparametric Wilcoxon test was used.
    Comparison groups
    Placebo v Verum
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05 [1]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - For statistical significance p<0.10 was also described.

    Primary: Effect of Placebo or Verum on spectral beta2 power

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    End point title
    		 Effect of Placebo or Verum on spectral beta2 power
    End point description
    Effect of Placebo or Verum (PASCOFLAIR®) on spectral beta2 power averaged including either all or selected electrode positions given on the right upper side. Data are given as % of baseline (ref) before intake. Statistical significance (Wilcoxon-Test) in comparison to Placebo is documented by stars: *=p<0.10; **=p<0.05.
    End point type
    Primary
    End point timeframe
    45 minutes after intake of study medication (verum or placebo)
    End point values
    		 Verum Placebo
    Number of subjects analysed
    20
    20
    Units: percent
        number (not applicable)
    20
    20
    Attachments
    		 verum vs. placebo beta2
    Statistical analysis title
    		 Wilcoxon test
    Statistical analysis description
    For explorative statistical evaluation the nonparametric Wilcoxon test was used.
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05 [2]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [2] - For statistical significance p<0.10 was also described.

    Secondary: Tolerability

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    End point title
    		 Tolerability
    End point description
    At the end of the measurements, the tolerability of verum or placebo was assessed: very good, good, moderately, poor.
    End point type
    Secondary
    End point timeframe
    One study day for each patient
    End point values
    		 Verum Placebo
    Number of subjects analysed
    20
    20
    Units: participants
    20
    20
    Attachments
    		 Tolerability
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Verum Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Verum Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    Investigations
    heart murmur
    Additional description: The volunteer has been informed about her heart murmur and was invited to a further visit.
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    increased GPT
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    increased GOT
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Apr 2015
    Changes in study protocol (version 2.0) Changes in ICF (version 3.0) Changes labeling study medication

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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