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    Clinical Trial Results:
    Effectiveness of CALMVALERA HEVERT as measured by quantitative EEG in 24 subjects during audio-visual cognitive and emotional challenges. A double-blind, randomized, placebo-controlled, 2-armed, Phase IV study in parallel design

    Summary
    EudraCT number
    		 2014-004840-36
    Trial protocol
    		 DE  
    Global end of trial date
    03 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Aug 2022
    First version publication date
    13 Aug 2022
    Other versions
    Summary report(s)
    		 CHDE-1 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    CHDE-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hevert-Arzneimittel GmbH & Co. KG
    Sponsor organisation address
    In der Weiherwiese 1, N, Germany, 55569
    Public contact
    Klinische Forschung Dr. Tausend, Hevert-Arzneimittel GmbH & Co. KG, 0049 6751910389, stausend@hevert.de
    Scientific contact
    Klinische Forschung Dr. Tausend, Hevert-Arzneimittel GmbH & Co. KG, 0049 6751910389, stausend@hevert.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
    30 Nov 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Anxiolytic effects of CALMVALERA HEVERT tablets 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) termed “EnkephaloVision”. Comparison of verum and placebo is performed on electric power in 17 different brain regions using six frequency ranges defined as target parameters in the presence of different stress inducing cognitive tests and emotional video scenes (i.e. quiz, memory test, Stroop test). With respect to cognition and emotion changes in frontal and temporal spectral beta power are evaluated.
    Protection of trial subjects
    No specific measures needed to be taken.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 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: 24
    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
    		 Healthy subjects aged 18-40 years, were recruited by NeuroCode AG, Sportparkstr. 9, D - 35578 Wetzlar, Germany

    Pre-assignment
    Screening details
    		 Subjects with an axiety test questionnaire “PAF” (for pre-selection of subjects) - values above T > 60 were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Calmvalera Hevert
    Arm description
    		 Single dose of Calmvalera Hevert
    Arm type
    		 Experimental

    Investigational medicinal product name
    Calmvalera Hevert
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject took a single dose of 6 tablets of Calmvalera Hevert

    Arm title
    		 Placebo
    Arm description
    		 Single dose of plabebo tablets
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects receive a single dose of 6 placebo tablets

    Number of subjects in period 1
    		Calmvalera Hevert Placebo
    Started
    12
    12
    Completed
    12
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 24 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 24.9 ( 4.21 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 10 10

    End points

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    End points reporting groups
    Reporting group title
    Calmvalera Hevert
    Reporting group description
    		 Single dose of Calmvalera Hevert

    Reporting group title
    Placebo
    Reporting group description
    		 Single dose of plabebo tablets

    Primary: Memory test

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    End point title
    		 Memory test [1]
    End point description
    The primary endpoint was the change in 17-channel EEG recording combined with eye-tracking after intake of Calmvalera in comparison to placebo. Method: Quantitative-topographical EEG by measurement of current source density during different cognitive and emotional challenges. Combination of Neurocode-Tracking (quantitative-topographic EEG with epoch length of 364 ms) with Eye-Tracking (following eye gazes) termed “EnkephaloVision. The results cannot be presented as numbers and units. A statistical significant increase of alpha1 and alpha2 activity was observed (see attached chart) after intake of Calmvalera, but not of delta-theta or beta electric activity nor psychometric performance.
    End point type
    Primary
    End point timeframe
    The memory test was a secondary endpoint, primary endpoint was the EEG evaluation, see description below.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical test was performed for the memory test.
    End point values
    		 Calmvalera Hevert Placebo
    Number of subjects analysed
    12
    12
    Units: Score points
        arithmetic mean (standard deviation)
    89.58 ( 16.71 )
    97.92 ( 7.22 )
    Attachments
    		 Effect of active and placebo
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From screening to final examination
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Calmvalera
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Calmvalera Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (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: 0%
    Non-serious adverse events
    		 Calmvalera Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No AEs were reported.

    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.
    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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