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    Clinical Trial Results:
    Effects of EGCG (Epigallocatechin Gallate) in Chorea Huntington

    Summary
    EudraCT number
    		 2010-023941-31
    Trial protocol
    		 DE  
    Global end of trial date
    09 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions
    Summary report(s)
    		 ETON Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    ETON
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01357681
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité - University Medicine Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Charité - University Medicine Berlin Dep. of Psychiatry and Psychotherapy Prof. Dr. J. Priller, Charité - University Medicine Berlin Dep. of Psychiatry and Psychotherapy Prof. Dr. J. Priller, 0049 30450617236, eike.spruth@charite.de
    Scientific contact
    Charité - University Medicine Berlin Dep. of Psychiatry and Psychotherapy Prof. Dr. J. Priller, Charité - University Medicine Berlin Dep. of Psychiatry and Psychotherapy Prof. Dr. J. Priller, 0049 30450617236, eike.spruth@charite.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
    09 Apr 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess efficacy of Sunphenon EGCG in patients with Huntington´s Disease
    Protection of trial subjects
    Safety laboratory tests, data safety concept, insurance. Treatet in routine care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2011
    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: 54
    Worldwide total number of subjects
    54
    EEA total number of subjects
    54
    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)
    49
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment from 26/SEP/2011 (first participant in) till 31/MAR/2014 (last participant in), 4 sites (Berlin, Bochum, Ulm, Muenster)

    Pre-assignment
    Screening details
    		 Screening period started on 26/SEP/2011 and endet on 27/MAR/2014.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EGCG
    Arm description
    		 Epigallocatechin-gallate 1200 mg per day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Epigallocatechin-gallate
    Investigational medicinal product code
    Other name
    Sunphenon EGCG
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    After confirmation of stability EGCG was encapsulated by the trial pharmacy (200 mg per hard gelatin capsule). Participants received 200 mg Sunphenon EGCG orally, b.i.d. for the first month, 400 mg b.i.d for the second month and 600 mg b.i.d. until month twelve (1200 mg/d). Study medication was administered in the fasting state, i.e. until 60 minutes prior or 60 minutes after breakfast or dinner.

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Administered twice daily for 12 months

    Number of subjects in period 1
    		EGCG Placebo
    Started
    30
    24
    Completed
    26
    20
    Not completed
    4
    4
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    3
    1
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EGCG
    Reporting group description
    		 Epigallocatechin-gallate 1200 mg per day

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 EGCG Placebo Total
    Number of subjects
    		 30 24 54
    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)
    		 49.5 ( 10.8 ) 47.8 ( 12.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 13 31
        Male
    		 12 11 23

    End points

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    End points reporting groups
    Reporting group title
    EGCG
    Reporting group description
    		 Epigallocatechin-gallate 1200 mg per day

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Cognitive total Score (UHDRS-COG)

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    End point title
    		 Cognitive total Score (UHDRS-COG)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    25 [1]
    20 [2]
    Units: Points
        arithmetic mean (standard deviation)
    -1.52 ( 18.590 )
    -1.30 ( 22.005 )
    Attachments
    		 Untitled (Filename: Clinical Outcome Measures After 12 Months.pdf)
    Notes
    [1] - missing values + drop outs excluded (ITT)
    [2] - missing values + drop outs excluded (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.661
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 mean rank difference
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Primary: Stroop total Score (STRP_T)

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    End point title
    		 Stroop total Score (STRP_T)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    26 [3]
    20 [4]
    Units: Points
        arithmetic mean (standard deviation)
    -3.04 ( 13.48 )
    1.20 ( 14.66 )
    Notes
    [3] - drop outs excluded (ITT)
    [4] - drop outs excluded (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.584
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 mean rank difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Primary: Symbol Digit Modalities Test (SDMT)

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    End point title
    		 Symbol Digit Modalities Test (SDMT)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    25 [5]
    20 [6]
    Units: Points
        arithmetic mean (standard deviation)
    -1.20 ( 4.40 )
    -2.15 ( 6.00 )
    Notes
    [5] - missing values + drop outs excluded (ITT)
    [6] - drop outs excluded (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.506
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 mean rank difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Primary: Verbal Fluency total Score (VF_T)

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    End point title
    		 Verbal Fluency total Score (VF_T)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    26 [7]
    20 [8]
    Units: Points
        arithmetic mean (standard deviation)
    2.00 ( 7.05 )
    -0.35 ( 5.10 )
    Notes
    [7] - drop outs excluded (ITT)
    [8] - drop outs excluded (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.123
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 mean rank difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Unified Huntington’s Disease Rating Scale (UHDRS) Motor Score (MS)

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    End point title
    		 Unified Huntington’s Disease Rating Scale (UHDRS) Motor Score (MS)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    26 [9]
    20 [10]
    Units: Points
        arithmetic mean (standard deviation)
    1.31 ( 5.050 )
    3.85 ( 5.687 )
    Notes
    [9] - after excluding drop outs (ITT)
    [10] - after excluding drop outs (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.192
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Cllinical Global Impression (CGI)

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    End point title
    		 Cllinical Global Impression (CGI)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    26 [11]
    20 [12]
    Units: Points
        arithmetic mean (standard deviation)
    0.27 ( 0.53 )
    0.00 ( 0.46 )
    Notes
    [11] - after excluding drop outs (ITT)
    [12] - after excluding drop outs (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.973
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Unified Huntington’s Disease Rating Scale (UHDRS) Functional Assessement (FA)

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    End point title
    		 Unified Huntington’s Disease Rating Scale (UHDRS) Functional Assessement (FA)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    26 [13]
    20 [14]
    Units: Points
        arithmetic mean (standard deviation)
    -0.50 ( 1.39 )
    -0.90 ( 2.13 )
    Notes
    [13] - after excluding drop outs (ITT)
    [14] - after excluding drop outs (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.906
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Unified Huntington’s Disease Rating Scale (UHDRS) Independance (IS)

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    End point title
    		 Unified Huntington’s Disease Rating Scale (UHDRS) Independance (IS)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    26 [15]
    20 [16]
    Units: Points
        arithmetic mean (standard deviation)
    -2.88 ( 5.32 )
    -1.00 ( 4.47 )
    Notes
    [15] - after excluding drop outs (ITT)
    [16] - after excluding drop outs (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.275
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Unified Huntington’s Disease Rating Scale (UHDRS) Behavioral Score (BA)

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    End point title
    		 Unified Huntington’s Disease Rating Scale (UHDRS) Behavioral Score (BA)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    26 [17]
    20 [18]
    Units: Points
        arithmetic mean (standard deviation)
    -2.42 ( 7.54 )
    1.15 ( 7.44 )
    Notes
    [17] - after excluding drop outs (ITT)
    [18] - after excluding drop outs (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.304
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Beck Depression Inventory (BDI)

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    End point title
    		 Beck Depression Inventory (BDI)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    26 [19]
    20 [20]
    Units: Points
        arithmetic mean (standard deviation)
    -0.73 ( 4.56 )
    -0.50 ( 4.97 )
    Notes
    [19] - drop outs excluded (ITT)
    [20] - drop outs excluded (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.987
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 mean rank difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Mini Mental State Examination (MMSE)

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    End point title
    		 Mini Mental State Examination (MMSE)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    26 [21]
    20 [22]
    Units: Points
        arithmetic mean (standard deviation)
    -0.31 ( 1.89 )
    -1.05 ( 2.33 )
    Notes
    [21] - drop outs excluded (ITT)
    [22] - drop outs excluded (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    Placebo v EGCG
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.397
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 mean rank difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Positive and Negative Affect Schedule (PANAS) - Negative Score

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    End point title
    		 Positive and Negative Affect Schedule (PANAS) - Negative Score
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    26 [23]
    20 [24]
    Units: Points
        arithmetic mean (standard deviation)
    -0.42 ( 4.51 )
    -1.40 ( 7.63 )
    Notes
    [23] - drop outs excluded (ITT)
    [24] - drop outs excluded (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    Placebo v EGCG
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.679
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 mean rank difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Positive and Negative Affect Schedule (PANAS) - Positive Score

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    End point title
    		 Positive and Negative Affect Schedule (PANAS) - Positive Score
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    26 [25]
    20 [26]
    Units: Points
        arithmetic mean (standard deviation)
    0.23 ( 6.52 )
    0.60 ( 7.72 )
    Notes
    [25] - drop outs excluded (ITT)
    [26] - drop outs excluded (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.591
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 mean rank difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Short Form (36) Health Survey (SF36) - Mental Health (Men)

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    End point title
    		 Short Form (36) Health Survey (SF36) - Mental Health (Men)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    24 [27]
    16 [28]
    Units: Points
        arithmetic mean (standard deviation)
    -2.10 ( 15.37 )
    -0.61 ( 14.32 )
    Notes
    [27] - missing values + drop outs excluded (ITT)
    [28] - missing values + drop outs excluded (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.618
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 mean rank difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Short Form (36) Health Survey (SF36) - Physical Functioning (Phy)

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    End point title
    		 Short Form (36) Health Survey (SF36) - Physical Functioning (Phy)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    24 [29]
    16 [30]
    Units: Points
        arithmetic mean (standard deviation)
    -2.44 ( 13.49 )
    -0.47 ( 6.16 )
    Notes
    [29] - missing values + drop outs excluded (ITT)
    [30] - missing values + drop outs excluded (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.953
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 mean rank difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Satisfaction with Life Scale (SWLS)

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    End point title
    		 Satisfaction with Life Scale (SWLS)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    26 [31]
    20 [32]
    Units: Points
        arithmetic mean (standard deviation)
    -1.00 ( 6.17 )
    -1.85 ( 7.40 )
    Notes
    [31] - drop outs excluded (ITT)
    [32] - drop outs excluded (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.996
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 mean rank difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Test of Attentional Performance (TAP) - Phasic Alertness (PA)

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    End point title
    		 Test of Attentional Performance (TAP) - Phasic Alertness (PA)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    23 [33]
    16 [34]
    Units: Points
        arithmetic mean (standard deviation)
    36.91 ( 129.91 )
    6.31 ( 62.81 )
    Notes
    [33] - missing values + drop outs excluded (ITT)
    [34] - missing values + drop outs excluded (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.928
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 mean rank difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Test of Attentional Performance (TAP) - Tonic Alertness (TA)

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    End point title
    		 Test of Attentional Performance (TAP) - Tonic Alertness (TA)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    23 [35]
    16 [36]
    Units: Points
        arithmetic mean (standard deviation)
    40.65 ( 131.06 )
    -21.69 ( 52.31 )
    Notes
    [35] - missing values + drop outs excluded (ITT)
    [36] - missing values + drop outs excluded (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    Placebo v EGCG
    Number of subjects included in analysis
    39
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.152
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 mean rank difference
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Unified Huntington’s Disease Rating Scale (UHDRS) Total Functional Capacity (TFC)

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    End point title
    		 Unified Huntington’s Disease Rating Scale (UHDRS) Total Functional Capacity (TFC)
    End point description
    Differences of baseline vs V14 (after 12 months) are reported
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 EGCG Placebo
    Number of subjects analysed
    26 [37]
    20 [38]
    Units: Points
        arithmetic mean (standard deviation)
    -0.04 ( 1.46 )
    -0.75 ( 1.68 )
    Notes
    [37] - drop outs excluded (ITT)
    [38] - drop outs excluded (ITT)
    Statistical analysis title
    		 Test of differences
    Statistical analysis description
    non-parametric Mann–Whitney U test
    Comparison groups
    EGCG v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.296
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 mean rank difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 self defined
    Dictionary version
    1
    Reporting groups
    Reporting group title
    EGCG
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 EGCG Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 30 (26.67%)
    8 / 24 (33.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Arrhythmia
    Additional description: Hospitalization
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Inguinal hernia
    Additional description: Hospitalization
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Removal of internal fixation
    Additional description: Hospitalization
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Investigation
    Additional description: Hospitalization
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Rehabilitation therapy
    Additional description: Hospitalization
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal tear
    Additional description: Hospitalization
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Breast cancer
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Liver disorder
    Additional description: Elevated aminotransferase concentrations
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Prurigo
    Additional description: Hospitalization
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Panic attack
    Additional description: Hospitalization
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
    Additional description: Hospitalization
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fracture treatment
    Additional description: Hospitalization
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Antibiotic therapy
    Additional description: Hospitalization
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 EGCG Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 30 (50.00%)
    14 / 24 (58.33%)
    Investigations
    Creatine kinase elevation
         subjects affected / exposed
    4 / 30 (13.33%)
    1 / 24 (4.17%)
         occurrences all number
    4
    7
    Cardiac disorders
    Cardiac disorder
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 24 (4.17%)
         occurrences all number
    2
    1
    Nervous system disorders
    Neurological symptom
         subjects affected / exposed
    6 / 30 (20.00%)
    4 / 24 (16.67%)
         occurrences all number
    6
    4
    Headache
         subjects affected / exposed
    2 / 30 (6.67%)
    4 / 24 (16.67%)
         occurrences all number
    2
    4
    General disorders and administration site conditions
    Fall
         subjects affected / exposed
    7 / 30 (23.33%)
    5 / 24 (20.83%)
         occurrences all number
    7
    5
    Eye disorders
    Eye disorder
         subjects affected / exposed
    4 / 30 (13.33%)
    1 / 24 (4.17%)
         occurrences all number
    4
    1
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    10 / 30 (33.33%)
    6 / 24 (25.00%)
         occurrences all number
    10
    6
    Respiratory, thoracic and mediastinal disorders
    Flu-like and respiratory symptoms
         subjects affected / exposed
    12 / 30 (40.00%)
    8 / 24 (33.33%)
         occurrences all number
    12
    8
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    6 / 30 (20.00%)
    0 / 24 (0.00%)
         occurrences all number
    6
    0
    Skin and subcutaneous tissue disorders
    Skin disorder
         subjects affected / exposed
    1 / 30 (3.33%)
    4 / 24 (16.67%)
         occurrences all number
    1
    4
    Psychiatric disorders
    Psychiatric symptom
         subjects affected / exposed
    8 / 30 (26.67%)
    6 / 24 (25.00%)
         occurrences all number
    8
    6
    Renal and urinary disorders
    Urinary tract disorder
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 24 (8.33%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    Musculoskeletal injury
         subjects affected / exposed
    4 / 30 (13.33%)
    7 / 24 (29.17%)
         occurrences all number
    4
    7

    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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