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    Clinical Trial Results:
    NEUPRO DB, efficacy profile of Neurexan in an experimental acute stress setting – an explorative double blind study in healthy probands

    Summary
    EudraCT number
    		 2012-002358-22
    Trial protocol
    		 DE  
    Global end of trial date
    02 Apr 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Oct 2017
    First version publication date
    28 Oct 2017
    Other versions
    Summary report(s)
    		 C1201 NEUPRO double blind study (Neurexan)

    Trial information

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    Trial identification
    Sponsor protocol code
    C1201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01703819
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biologische Heilmittel Heel GmbH
    Sponsor organisation address
    Dr.-Reckeweg-Str. 2-4, Baden-Baden, Germany, 76532
    Public contact
    Biologische Heilmittel Heel GmbH, Biologische Heilmittel Heel GmbH, +49 7221-501-0, info@heel.com
    Scientific contact
    Biologische Heilmittel Heel GmbH, Biologische Heilmittel Heel GmbH, +49 7221-501-0, info@heel.com
    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
    02 Apr 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Apr 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Apr 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is the efficacy of Neurexan® on tension and nervousness perception using visual analogue scales (VAS) when study participants undergo an emotional stressful condition as compared to Placebo. The test method for this study is the TSST protocol.
    Protection of trial subjects
    Routine monitoring was performed to verify that rights and well being of participants were protected.
    Background therapy
    		 6 subjects took contraceptives (2 in the Neurexan Group, 4 in the Placebo Group)
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Oct 2012
    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: 66
    Worldwide total number of subjects
    66
    EEA total number of subjects
    66
    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)
    66
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was carried out in 2 outpatient clinics in Germany (Marburg and Essen). 35 subjects were enrolled in Marburg and 31 in Essen.

    Pre-assignment
    Screening details
    		 Telephone pre-screening was carried out and individuals received gross Information about the study. If they were suited for study participation an appointment for the medical and psychological screening was made. Interested volunteers were invited to the study site for the 1st visit and received oral and written Information about study and ICF.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Participants were randomly allocated to either treatment group in a 1:1 randomisation. Randomisation was stratified by site and by gender.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Neurexan group
    Arm description
    		 34 participants were randomized to Neurexan. All randomized participants in this Group formed the full analysis set for analysis of efficacy and safety. Subjects took 6 Neurexan tablets over a period of 2.5 hours (one tablet every 30 minutes).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Neurexan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One Neurexan tablet contains: 0.6 mg Avena sativa (dil. D2), 0.6 mg Coffea arabica (dil. D12), 0.6 mg Passiflora incarnata (dil. D2), 0.6 mg Zincum isovalerianum (dil. D4), lactose monohydrate and magnesium stearate Route of administration: oral Total administered: 6 tablets (over a period of 2.5 hours - one tablet every 30 minutes)

    Arm title
    		 Placebo group
    Arm description
    		 32 participants were randomized to placebo. Two premature terminators could not be evaluated for primary efficacy, so only 30 participants in this group formed the full analysis set for analysis of efficacy. All randomised participants (32) were included in the safety analysis. Subjects took 6 placebo tablets over a period of 2.5 hours (one tablet every 30 minutes)
    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
    Each placebo tablet contains: lactose monohydrate and magnesium stearate Route of administration: oral Total administered: 6 tablets (over a period of 2.5 hours - one tablet every 30 minutes)

    Number of subjects in period 1
    		Neurexan group Placebo group
    Started
    34
    32
    Completed
    34
    30
    Not completed
    0
    2
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Neurexan group
    Reporting group description
    		 34 participants were randomized to Neurexan. All randomized participants in this Group formed the full analysis set for analysis of efficacy and safety. Subjects took 6 Neurexan tablets over a period of 2.5 hours (one tablet every 30 minutes).

    Reporting group title
    Placebo group
    Reporting group description
    		 32 participants were randomized to placebo. Two premature terminators could not be evaluated for primary efficacy, so only 30 participants in this group formed the full analysis set for analysis of efficacy. All randomised participants (32) were included in the safety analysis. Subjects took 6 placebo tablets over a period of 2.5 hours (one tablet every 30 minutes)

    Reporting group values
    		 Neurexan group Placebo group Total
    Number of subjects
    		 34 32 66
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 34 32 66
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.1 ( 7 ) 40.7 ( 8.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 16 16 32
        Male
    		 18 16 34
    Ethnic origin
    Units: Subjects
        white
    		 34 32 66
    Body mass index (BMI)
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 24.31 ( 2.94 ) 24.68 ( 2.85 ) -
    Trier Inventory for Chronic Stress - screening scale of chronic stress (SCSS)
    includes scores from five scales (chronic worrying, work and social overload, excessive demands and lack of acceptance).
    Units: score points
        median (full range (min-max))
    		 8 (0 to 17) 10 (0 to 26) -
    Global Severity Index (GSI) of psychological distress
    Derived from Symptom Checklist 90.
    Units: score points
        median (full range (min-max))
    		 0.122 (0.01 to 0.46) 0.144 (0 to 0.38) -
    Screening height
    Units: cm
        arithmetic mean (standard deviation)
    		 173.5 ( 8.8 ) 174.1 ( 9.3 ) -
    Screening weight
    Units: kg
        arithmetic mean (standard deviation)
    		 73.43 ( 11.76 ) 75.11 ( 12.56 ) -
    Subject analysis sets

    Subject analysis set title
    Neurexan Essen group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The secondary endpoint "Change in natural killer (NK) cells" was analysed in the Essen subgroup only.

    Subject analysis set title
    Placebo Essen group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The secondary endpoint "Change in natural killer (NK) cells" was analysed in the Essen subgroup only.

    Subject analysis sets values
    		 Neurexan Essen group Placebo Essen group
    Number of subjects
    15
    16
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    15
    16
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male
    Ethnic origin
    Units: Subjects
        white
    Body mass index (BMI)
    Units: kg/m2
        arithmetic mean (standard deviation)
    ( )
    ( )
    Trier Inventory for Chronic Stress - screening scale of chronic stress (SCSS)
    includes scores from five scales (chronic worrying, work and social overload, excessive demands and lack of acceptance).
    Units: score points
        median (full range (min-max))
    Global Severity Index (GSI) of psychological distress
    Derived from Symptom Checklist 90.
    Units: score points
        median (full range (min-max))
    Screening height
    Units: cm
        arithmetic mean (standard deviation)
    ( )
    ( )
    Screening weight
    Units: kg
        arithmetic mean (standard deviation)
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    Neurexan group
    Reporting group description
    		 34 participants were randomized to Neurexan. All randomized participants in this Group formed the full analysis set for analysis of efficacy and safety. Subjects took 6 Neurexan tablets over a period of 2.5 hours (one tablet every 30 minutes).

    Reporting group title
    Placebo group
    Reporting group description
    		 32 participants were randomized to placebo. Two premature terminators could not be evaluated for primary efficacy, so only 30 participants in this group formed the full analysis set for analysis of efficacy. All randomised participants (32) were included in the safety analysis. Subjects took 6 placebo tablets over a period of 2.5 hours (one tablet every 30 minutes)

    Subject analysis set title
    Neurexan Essen group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The secondary endpoint "Change in natural killer (NK) cells" was analysed in the Essen subgroup only.

    Subject analysis set title
    Placebo Essen group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The secondary endpoint "Change in natural killer (NK) cells" was analysed in the Essen subgroup only.

    Primary: Tension

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    End point title
    		 Tension
    End point description
    Tension was self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), ranging from 0="not at all" to 100="higly", before and after a stress test. The measurements started with first intake of Neurexan or Placebo and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method. AUC of VAS Tension value was measured from -210 min to +100 min.
    End point type
    Primary
    End point timeframe
    From first intake of Neurexan or Placebo until 100 minutes after end of the stress test, i.e.: -210 min, -180 min, -150 min, -120 min, -90 min, -60 min, -30 min, -15 min, 0 min, +15 min, +30 min, +45 min, +60 min, +75 min, +100 min
    End point values
    		 Neurexan group Placebo group
    Number of subjects analysed
    34
    30
    Units: mm* min
        median (full range (min-max))
    3335.7 (345 to 16411)
    3360.3 (0 to 21115)
    Statistical analysis title
    		 Descriptive statistics
    Statistical analysis description
    Standard descriptive statistics were calculated for continuous variables. All analyses were performed using Version 9.1.3 or later of SAS Software.
    Comparison groups
    Neurexan group v Placebo group
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 = 0.7726
    Method
    		 ANCOVA
    Parameter type
    		 LS-Mean difference
    Point estimate
    186.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1099.1
         upper limit
    		 1472.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    642.5
    Notes
    [1] - Null-hypotheses of no Treatment differences were tested by the two-sided-t-tests from the respective ANCOVAs.

    Primary: Nervousness

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    End point title
    		 Nervousness
    End point description
    Nervousness was self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), ranging from 0="not at all" to 100="higly", before and after a stress test. The measurements started with first intake of Neurexan or Placebo and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method. AUC of VAS Nervousness value was measured from -210 min to +100 min.
    End point type
    Primary
    End point timeframe
    From first intake of Neurexan or Placebo until 100 minutes after end of the stress test, i.e.: -210 min, -180 min, -150 min, -120 min, -90 min, -60 min, -30 min, -15 min, 0 min, +15 min, +30 min, +45 min, +60 min, +75 min, +100 min
    End point values
    		 Neurexan group Placebo group
    Number of subjects analysed
    34
    30
    Units: mm* min
        median (full range (min-max))
    3147.4 (247 to 17050)
    3022.5 (0 to 21409)
    Statistical analysis title
    		 Descriptive statistics
    Statistical analysis description
    Standard descriptive statistics were calculated for continuous variables. All analyses were performed using Version 9.1.3 or later of SAS Software.
    Comparison groups
    Neurexan group v Placebo group
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    P-value
    		 = 0.5702
    Method
    		 ANCOVA
    Parameter type
    		 LS-Mean difference
    Point estimate
    335.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -839.3
         upper limit
    		 1509.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    586.9
    Notes
    [2] - Null-hypotheses of no Treatment differences were tested by the two-sided-t-tests from the respective ANCOVAs.

    Secondary: Salivary alpha amylase

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    End point title
    		 Salivary alpha amylase
    End point description
    The stress biomarker salivary alpha amylase was measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    60 minutes before until 100 minutes after stress test, i.e.: -60 min, +15 min, +45 min, +100 min
    End point values
    		 Neurexan group Placebo group
    Number of subjects analysed
    34
    30
    Units: IU/ml
    median (full range (min-max))
        -60 min
    112.9 (19.65 to 353.65)
    133.3 (23.73 to 421.05)
        +15 min
    201.9 (78.41 to 729.7)
    216 (49.3 to 670.89)
        +45 min
    140.8 (25.55 to 420.4)
    142.1 (37.1 to 484.75)
        +100 min
    149.9 (29.19 to 465.07)
    140.6 (35.11 to 417.27)
    No statistical analyses for this end point

    Secondary: Saliva cortisol

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    End point title
    		 Saliva cortisol
    End point description
    The stress biomarker saliva cortisol was measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    60 minutes before until 100 minutes after stress test, i.e.: -60 min, +15 min, +45 min, +100 min
    End point values
    		 Neurexan group Placebo group
    Number of subjects analysed
    34
    30
    Units: nmol/l
    median (full range (min-max))
        -60 min
    7.1 (2.96 to 17.44)
    7.1 (2.73 to 32.43)
        +15 min
    19.4 (7.18 to 120.83)
    20 (6.14 to 86.62)
        +45 min
    15.3 (6.96 to 80.66)
    21.3 (3.93 to 81.35)
        +100 min
    6.4 (3.74 to 20.94)
    8.9 (3.61 to 21.24)
    No statistical analyses for this end point

    Secondary: Adrenocorticotropic Hormone (ACTH)

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    End point title
    		 Adrenocorticotropic Hormone (ACTH)
    End point description
    The stress biomarker Adrenocorticotropic Hormone was measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    60 minutes before until 100 minutes after stress test, i.e.: -60 min, +15 min, +45 min, +100 min
    End point values
    		 Neurexan group Placebo group
    Number of subjects analysed
    34
    30
    Units: ng/L
    median (full range (min-max))
        -60 min
    22.5 (9.17 to 330.41)
    19.1 (5.45 to 493.16)
        +15 min
    37.7 (13.87 to 124.21)
    37 (13.63 to 209.74)
        +45 min
    20.3 (7.49 to 42.29)
    20.7 (7.47 to 79.36)
        +100 min
    11.3 (3.18 to 24.44)
    10.7 (5.44 to 23.96)
    No statistical analyses for this end point

    Secondary: Epinephrine

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    End point title
    		 Epinephrine
    End point description
    The stress biomarker epinephrine (adrenaline) measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    60 minutes before until 100 minutes after stress test, i.e.: -60 min, +15 min, +45 min, +100 min
    End point values
    		 Neurexan group Placebo group
    Number of subjects analysed
    34
    30
    Units: ng/l
    median (full range (min-max))
        -60 min
    42.6 (10 to 98)
    35.6 (8.1 to 146)
        +15 min
    32.9 (10 to 116)
    47.4 (10 to 126)
        +45 min
    41.4 (10 to 152)
    26.4 (10 to 101)
        +100 min
    31.9 (0 to 91.3)
    41.1 (11.3 to 89.9)
    No statistical analyses for this end point

    Secondary: Norepineprhine

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    End point title
    		 Norepineprhine
    End point description
    The stress biomarker norepinephrine was measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    60 minutes before until 100 minutes after stress test, i.e.: -60 min, +15 min, +45 min, +100 min
    End point values
    		 Neurexan group Placebo group
    Number of subjects analysed
    34
    30
    Units: ng/l
    median (full range (min-max))
        -60 min
    463 (99 to 990)
    457 (253 to 1329)
        +15 min
    584 (150 to 1352)
    591.5 (316 to 1856)
        +45 min
    481 (231 to 1530)
    476 (168 to 1189)
        +100 min
    451.5 (215 to 1318)
    482.5 (230 to 815)
    No statistical analyses for this end point

    Secondary: Plasma Cortisol

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    End point title
    		 Plasma Cortisol
    End point description
    The stress biomarker plasma cortisol was measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    60 minutes before until 100 minutes after stress test, i.e.: -60 min, +15 min, +45 min, +100 min
    End point values
    		 Neurexan group Placebo group
    Number of subjects analysed
    34
    30
    Units: nmol/l
    median (full range (min-max))
        -60 min
    331.6 (97.61 to 614.82)
    325.5 (54.18 to 1006.68)
        +15 min
    441.1 (281.35 to 987.1)
    569.8 (174.14 to 1048.65)
        +45 min
    403.1 (223.67 to 1259.65)
    535.4 (142.47 to 841.16)
        +100 min
    228.4 (94.57 to 671.77)
    273.3 (108.54 to 658.03)
    No statistical analyses for this end point

    Secondary: Change in natural killer cells

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    End point title
    		 Change in natural killer cells
    End point description
    The Natural Killer (NK) Cells as immune cells and stress biomarkers were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    60 minutes before until 100 minutes after stress test, i.e.: -60 min, +15 min, +45 min, +100 min
    End point values
    		 Neurexan Essen group Placebo Essen group
    Number of subjects analysed
    15
    16
    Units: % of lymphocytes
    median (full range (min-max))
        -60 min
    13.5 (5.5 to 23.2)
    11.65 (6.3 to 21)
        +15 min
    21 (9.1 to 36.2)
    20.4 (8 to 37.3)
        +45 min
    10.3 (3.3 to 20.4)
    9.1 (5.4 to 18.6)
        +100 min
    13.1 (4.3 to 20.9)
    8.65 (5.5 to 21.5)
    No statistical analyses for this end point

    Secondary: Systolic blood pressure

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    End point title
    		 Systolic blood pressure
    End point description
    Systolic blood pressure was measured before and after a stress test by continuous cardiovascular recording. The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    30 minutes before until 45 minutes after stress test, i.e.: -15 min, 0 min, +15 min, +45 min
    End point values
    		 Neurexan group Placebo group
    Number of subjects analysed
    34
    30
    Units: mmHg
    median (full range (min-max))
        -15 min
    122 (96 to 153)
    123.5 (102 to 147)
        0 min
    132 (106 to 201)
    142 (110 to 168)
        +15 min
    125 (99 to 164)
    133.5 (105 to 153)
        +45 min
    121.5 (96 to 163)
    125 (101 to 182)
    No statistical analyses for this end point

    Secondary: Diastolic blood pressure

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    End point title
    		 Diastolic blood pressure
    End point description
    Diastoblic blood pressure was measured before and after a stress test by continuous cardiovascular recording. The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    30 minutes before until 45 minutes after stress test, i.e.: -15 min, 0 min, +15 min, +45 min
    End point values
    		 Neurexan group Placebo group
    Number of subjects analysed
    34
    30
    Units: mmHg
    median (full range (min-max))
        -15 min
    79.5 (58 to 109)
    81.5 (61 to 98)
        0 min
    81 (66 to 117)
    91 (63 to 107)
        +15 min
    83.5 (65 to 115)
    89 (63 to 109)
        +45 min
    81 (34 to 113)
    83 (63 to 113)
    No statistical analyses for this end point

    Secondary: Heart rate

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    End point title
    		 Heart rate
    End point description
    Heart rate was measured before and after a stress test by continuous cardiovascular recording. The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    30 minutes before until 45 minutes after stress test, i.e.: -15 min, 0 min, +15 min, +45 min
    End point values
    		 Neurexan group Placebo group
    Number of subjects analysed
    34
    30
    Units: bpm
    median (full range (min-max))
        -15 min
    70 (55 to 96)
    69 (52 to 94)
        0 min
    88 (65 to 115)
    89.5 (65 to 131)
        +15 min
    69.5 (56 to 94)
    71 (53 to 119)
        +45 min
    71 (59 to 106)
    71 (55 to 91)
    No statistical analyses for this end point

    Secondary: Modified somatic SCL90

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    End point title
    		 Modified somatic SCL90
    End point description
    The SCL90 has 90 items and covers dimensions like depression, somatization, obsessive-compulsive disorder, social insecurity, anxiety, phobic anxiety, aggression/hostility, paranoid ideation, psychoticism. A new instrument covering potential somatic stress consequences was used in this study, the modified somatic SCL90 that uses the SCL90 somatization items, but instead of a 7 day timeframe asking for "now" (current state). The corresponding items from SCL90 were: 1, 4, 12, 27, 40, 42, 48, 49, 52, 53, 56, 58 and the introductory question had to be: “How much do you currently suffer from...” ("Wie sehr leiden Sie momentan unter:").
    End point type
    Secondary
    End point timeframe
    210 minutes before and 100 minutes after stress test, i.e: -210 min, +100 min
    End point values
    		 Neurexan group Placebo group
    Number of subjects analysed
    33
    30
    Units: score points
    median (full range (min-max))
        -210 min
    0 (0 to 10)
    0 (0 to 5)
        +100 min
    0 (0 to 9)
    0 (0 to 4)
    No statistical analyses for this end point

    Secondary: State anxiety and stress perception measured by State-Trait Anxiety Inventory X1

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    End point title
    		 State anxiety and stress perception measured by State-Trait Anxiety Inventory X1
    End point description
    State anxiety and stress perception were measured by State-Trait Anxiety Inventory X1 before and after a stress test. The measurements took place 90 minutes before stress test and were repeated 15 and 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    90 minutes before stress test and 15 and 100 minutes after the end of the stress test, i.e.: -90 min, +15 min, +100 min
    End point values
    		 Neurexan group Placebo group
    Number of subjects analysed
    34
    30
    Units: score points
    median (full range (min-max))
        -90 min
    31 (21 to 45)
    29.5 (22 to 50)
        +15 min
    54.5 (24 to 74)
    51.5 (23 to 68)
        +100 min
    33 (20 to 69)
    32.5 (20 to 69)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Randomization until individual study end, i.e.: -180 min, -150 min, -120 min, -90 min, -60 min, -30min, -15 min, 0 min, +15 min, +30 min, +45 min, +60 min, +75 min, +100 min
    Adverse event reporting additional description
    All adverse events that occurred after the participant has received at least one dose of the product under investigation were to be collected and reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Neurexan group
    Reporting group description
    		 34 participants were randomized to Neurexan. All randomized participants in this group formed the full analysis set for analysis of efficacy and safety.

    Reporting group title
    Placebo Group
    Reporting group description
    		 32 participants who were randomized to placebo were included in the safety Analysis.

    Serious adverse events
    		 Neurexan group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 32 (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
    		 Neurexan group Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 34 (11.76%)
    3 / 32 (9.38%)
    Investigations
    decreased blood pressure
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    3
    Nervous system disorders
    dizziness
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 32 (3.13%)
         occurrences all number
    2
    2
    headache
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    tremor (legs)
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    fatigue
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    feeling cold
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    nausea
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    2

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/17615391
    http://www.ncbi.nlm.nih.gov/pubmed/16952284
    http://www.ncbi.nlm.nih.gov/pubmed/8255414
    http://www.ncbi.nlm.nih.gov/pubmed/19837490
    http://www.ncbi.nlm.nih.gov/pubmed/4303377
    http://www.ncbi.nlm.nih.gov/pubmed/5535207
    http://www.ncbi.nlm.nih.gov/pubmed/10600217
    http://www.ncbi.nlm.nih.gov/pubmed/8598500
    http://www.ncbi.nlm.nih.gov/pubmed/9491439
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