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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and safety of Pramipexole IR (0.0625-0.5 mg/day) versus placebo for 6 weeks in children and adolescents (age 6-17 inclusive) diagnosed with Tourette Disorder according to DSM-IV criteria

    Summary
    EudraCT number
    		 2008-004460-39
    Trial protocol
    		 DE   Outside EU/EEA  
    Global end of trial date
    23 Jun 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2016
    First version publication date
    17 May 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    248.644
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00558467
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim Pharma GmbH & Co. KG
    Sponsor organisation address
    Binger Strasse 173 , Ingelheim am Rhein , Germany, 55216
    Public contact
    Boehringer Ingelheim Pharma GmbH & Co KG, QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, 001 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    Boehringer Ingelheim Pharma GmbH & Co KG, QRPE Processes and Systems Coordination Clinical Trial Information Disclosure , 001 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000041-PIP01-07
    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
    27 Jul 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jun 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to evaluate the safety and efficacy of the non ergot dopamine agonist pramipexole for the treatment of tics in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Disorder according to DSM-IV criteria. The primary efficacy measure will be the Total Tic Score (TTS) of the YGTSS at 6 weeks.
    Protection of trial subjects
    Only subjects who were considered eligible by investigators based on the protocol-specified inclusion and exclusion criteria were entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jan 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    United States: 60
    Worldwide total number of subjects
    68
    EEA total number of subjects
    8
    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)
    32
    Adolescents (12-17 years)
    36
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subject) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    All study medication was double-blind, so that the treatments were indistinguishable. The Clinical Monitor, the Investigator and the patient were not aware of which treatment group the patient was randomised.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pramipexole
    Arm description
    		 Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) was administered orally. Starting dose 0.0625 mg bid (twice daily), with possible down titration after one week to 0.0625 mg qd (once daily) or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid (three times daily), after the third week optional up titration to 0.25 mg bid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sifrol®, Mirapex®, Mirapexin®, Pexola®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) was orally administered having duration of 6 weeks. Starting dose 0.0625 mg bid, after 7 days patient who tolerated dose 0.0625 mg bid were permitted to up titrate to a dose 0.125 mg bid and increase the dose subsequently. Patients who did not tolerate were permitted to down titrate to a dose of 0.0625 mg qd and continue on this dose for the remainder of the trial.

    Arm title
    		 Placebo
    Arm description
    		 Placebo tablets matching the Pramipexole tablets was administered orally.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo matching the Pramipexole tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be orally administered having duration of 6 weeks. Starting dose of 0.0625 mg bid matching placebo , after 7 days patient who tolerated dose 0.0625mg bid were permitted to up titrate to a dose 0.125 mg bid matcing placebo and increase the dose subsequently. Patients who did not tolerate were permitted to down titrate to a dose of 0.0625 mg qd matching placebo and continue on this dose for the remainder of the trial.

    Number of subjects in period 1 [1]
    		Pramipexole Placebo
    Started
    43
    20
    Completed
    39
    19
    Not completed
    4
    1
         Adverse event, non-fatal
    2
    1
         Other
    1
    -
         Lack of efficacy
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics are based on the patients who were randomised after successfully completing the screening period and received at least one of the trial medication.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pramipexole
    Reporting group description
    		 Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) was administered orally. Starting dose 0.0625 mg bid (twice daily), with possible down titration after one week to 0.0625 mg qd (once daily) or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid (three times daily), after the third week optional up titration to 0.25 mg bid.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo tablets matching the Pramipexole tablets was administered orally.

    Reporting group values
    		 Pramipexole Placebo Total
    Number of subjects
    		 43 20 63
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.2 ± 2.4 11.1 ± 3.2 -
    Gender categorical
    Units: Subjects
        Female
    		 8 2 10
        Male
    		 35 18 53
    Attention Deficit Hyperactive Disorder
    Diagnosis of disorder was performed using National Institute of Mental Health Diagnostic Interview Schedule for Children (NIMH DISC IV) and resulted in patients being classified as negative diagnosis, intermediate diagnosis and positive diagnosis for disorder.
    Units: Subjects
        Intermediate
    		 6 3 9
        Negative
    		 22 9 31
        Positive
    		 15 8 23
    Duration of Tourettes syndrome
    Units: Subjects
         1-5 years
    		 19 10 29
        Less than 1 year
    		 12 6 18
        More than 5 years
    		 12 4 16
    Ethnicity, Customized
    Units: Subjects
        Hispanic/Latino
    		 5 2 7
        Not Hispanic/Latino
    		 38 18 56
    Obsessive Compulsive Disorder
    Diagnosis of disorder was performed using National Institute of Mental Health Diagnostic Interview Schedule for Children (NIMH DISC IV) and resulted in patients being classified as negative, intermediate and positive for disorder.
    Units: Subjects
        Intermediate
    		 3 1 4
        Negative
    		 37 16 53
        Positive
    		 3 3 6
    Race, Customized
    Units: Subjects
        Black/African American
    		 4 2 6
        White
    		 39 18 57
    Body Mass Index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 22.575 ± 5.656 20.085 ± 5.324 -
    Height
    Units: Centimeters
        arithmetic mean (standard deviation)
    		 155.3 ± 16.2 150.7 ± 21.6 -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 55.87 ± 20.64 47.48 ± 21.29 -

    End points

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    End points reporting groups
    Reporting group title
    Pramipexole
    Reporting group description
    		 Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) was administered orally. Starting dose 0.0625 mg bid (twice daily), with possible down titration after one week to 0.0625 mg qd (once daily) or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid (three times daily), after the third week optional up titration to 0.25 mg bid.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo tablets matching the Pramipexole tablets was administered orally.

    Primary: Mean change from baseline in Total Tic Score of the Yale Global Tic Severity Scale after 6 weeks of treatment

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    End point title
    		 Mean change from baseline in Total Tic Score of the Yale Global Tic Severity Scale after 6 weeks of treatment
    End point description
    Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. Analysis was adjusted for baseline total tic score and age as linear covariates. The Full Analysis Set (FAS) included all patients who were randomised and have both a baseline and at least one post-baseline TTS value. This data set, used for the primary analysis for the primary endpoint, included 62 patients.
    End point type
    Primary
    End point timeframe
    baseline and week 6
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [1]
    20 [2]
    Units: score on a scale
        least squares mean (standard error)
    -7.16 ± 1.38
    -7.17 ± 2.02
    Notes
    [1] - FAS Set
    [2] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    The analysis of covariance (ANCOVA) model with treatment and pooled center fixed classification effects and the baseline TTS score and age as linear covariates was used for comparing treatment effects on Mean change from baseline to end of treatment visit in Total Tic Score (TTS) of the Yale Global Tic Severity Scale. The Last Observation Carried Forward (LOCF) method was used to handle missing data. Least square mean difference to placebo is calculated.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.996
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.95
         upper limit
    		 4.97

    Secondary: Mean change from baseline in Total Tic Score of the Yale Global Tic Severity Scale at week 1

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    End point title
    		 Mean change from baseline in Total Tic Score of the Yale Global Tic Severity Scale at week 1
    End point description
    Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50
    End point type
    Secondary
    End point timeframe
    baseline and week 1
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [3]
    20 [4]
    Units: score on a scale
        arithmetic mean (standard deviation)
    -4.1 ± 5.4
    -3.7 ± 4.1
    Notes
    [3] - FAS Set
    [4] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    Analysis comparing treatment effects on Mean change from baseline to end of treatment visit in Total Tic Score (TTS) of the Yale Global Tic Severity Scale at week 1. The least square mean differences to placebo group was calculated.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Repeated Measures
    Parameter type
    		 Least square means difference
    Point estimate
    -3.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.81
         upper limit
    		 -2.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.95

    Secondary: Mean change from baseline in Total Tic Score of the Yale Global Tic Severity Scale at week 2

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    End point title
    		 Mean change from baseline in Total Tic Score of the Yale Global Tic Severity Scale at week 2
    End point description
    Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50
    End point type
    Secondary
    End point timeframe
    baseline and week 2
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    41 [5]
    19 [6]
    Units: score on a scale
        arithmetic mean (standard deviation)
    -5 ± 7.4
    -5.3 ± 7.9
    Notes
    [5] - FAS Set 41 patients data were available for this enpoint, so 41 patients were analysed.
    [6] - FAS Set 19 patients data were available for this enpoint, so 19 patients were analysed.
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    Analysis comparing treatment effects on Mean change from baseline to end of treatment visit in Total Tic Score (TTS) of the Yale Global Tic Severity Scale at week 2. The least square mean differences to placebo group was calculated.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Repeated measures
    Parameter type
    		 Least square means difference
    Point estimate
    -5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.21
         upper limit
    		 -3.39
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.97

    Secondary: Mean change from baseline in Total Tic Score of the Yale Global Tic Severity Scale at week 3

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    End point title
    		 Mean change from baseline in Total Tic Score of the Yale Global Tic Severity Scale at week 3
    End point description
    Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50
    End point type
    Secondary
    End point timeframe
    baseline and week 3
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    41 [7]
    19 [8]
    Units: score on a scale
        arithmetic mean (standard deviation)
    -5.4 ± 6.3
    -6.2 ± 6.3
    Notes
    [7] - FAS Set 41 patients data were available for this enpoint, so 41 patients were analysed.
    [8] - FAS Set 19 patients data were available for this enpoint, so 19 patients were analysed.
    Statistical analysis title
    		 Placebo Vs Pramipexole
    Statistical analysis description
    Analysis comparing treatment effects on Mean change from baseline to end of treatment visit in Total Tic Score (TTS) of the Yale Global Tic Severity Scale at week 3. The least square mean differences to placebo group was calculated.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Repeated Measures
    Parameter type
    		 Least square means difference
    Point estimate
    -5.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.88
         upper limit
    		 -4.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.97

    Secondary: Mean change from baseline in Total Tic Score of the Yale Global Tic Severity Scale at week 4

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    End point title
    		 Mean change from baseline in Total Tic Score of the Yale Global Tic Severity Scale at week 4
    End point description
    Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50
    End point type
    Secondary
    End point timeframe
    baseline and week 4
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    40 [9]
    19 [10]
    Units: score on a scale
        arithmetic mean (standard deviation)
    -6.4 ± 7.3
    -6 ± 7.9
    Notes
    [9] - FAS Set 40 patients data were available for this enpoint, so 40 patients were analysed.
    [10] - FAS Set 19 patients data were available for this enpoint, so 19 patients were analysed .
    Statistical analysis title
    		 Placebo Vs Pramipexole
    Statistical analysis description
    This Repeated measure mixed effect model included effects accounting for the following sources of variation: “treatment” and ”center” as fixed effects, “time” as repeated effect, the interaction effect ”treatment-by time” and the respective baseline as covariates. The covariance structure was ”Compound symmetry”. The least square mean differences to placebo group was calculated.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Repeated measures
    Parameter type
    		 Least square means difference
    Point estimate
    -6.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.31
         upper limit
    		 -4.47
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.97

    Secondary: Mean change from baseline in Total Score of the Yale Global Tic Severity Scale due to motor and phonic tics at week 6

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    End point title
    		 Mean change from baseline in Total Score of the Yale Global Tic Severity Scale due to motor and phonic tics at week 6
    End point description
    Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
    End point type
    Secondary
    End point timeframe
    baseline and week 6
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [11]
    20 [12]
    Units: score on a scale
        arithmetic mean (standard deviation)
    -16.7 ± 16.8
    -15.8 ± 24.2
    Notes
    [11] - FAS Set
    [12] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    The analysis of covariance (ANCOVA) model with treatment and pooled center fixed classification effects and the baseline Total score and age as linear covariates was used for comparing treatment effects on Mean change from baseline to end of treatment visit in Total Score of the Yale Global Tic Severity Scale due to motor and phonic tics at week 6. The Last Observation Carried Forward (LOCF) method was used to handle missing data. Least square mean difference to placebo is calculated.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.978
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean differnce
    Point estimate
    -0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.05
         upper limit
    		 10.75

    Secondary: Mean change from baseline in Total Score of the Yale Global Tic Severity Scale due to motor and phonic tics at week 1

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    End point title
    		 Mean change from baseline in Total Score of the Yale Global Tic Severity Scale due to motor and phonic tics at week 1
    End point description
    Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
    End point type
    Secondary
    End point timeframe
    baseline and week 1
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [13]
    20 [14]
    Units: score on a scale
        arithmetic mean (standard deviation)
    -8.8 ± 11.1
    -6.2 ± 13.3
    Notes
    [13] - FAS Set
    [14] - FAS Set
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Total Score of the Yale Global Tic Severity Scale due to motor and phonic tics at week 2

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    End point title
    		 Mean change from baseline in Total Score of the Yale Global Tic Severity Scale due to motor and phonic tics at week 2
    End point description
    Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
    End point type
    Secondary
    End point timeframe
    baseline and week 2
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    41 [15]
    19 [16]
    Units: score on a scale
        arithmetic mean (standard deviation)
    -10.6 ± 17.5
    -9.5 ± 16.1
    Notes
    [15] - FAS Set 41 patients data were available for this enpoint, so 41 patients were analysed.
    [16] - FAS Set 19 patients data were available for this enpoint, so 19 patients were analysed.
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Total Score of the Yale Global Tic Severity Scale due to motor and phonic tics at week 3

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    End point title
    		 Mean change from baseline in Total Score of the Yale Global Tic Severity Scale due to motor and phonic tics at week 3
    End point description
    Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
    End point type
    Secondary
    End point timeframe
    baseline and week 3
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    41 [17]
    19 [18]
    Units: score on a scale
        arithmetic mean (standard deviation)
    -12.2 ± 15.7
    -14.1 ± 17.2
    Notes
    [17] - FAS Set 41 patients data were available for this enpoint, so 41 patients were analysed.
    [18] - FAS Set 19 patients data were available for this enpoint, so 19 patients were analysed.
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Total Score of the Yale Global Tic Severity Scale due to motor and phonic tics at week 4

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    End point title
    		 Mean change from baseline in Total Score of the Yale Global Tic Severity Scale due to motor and phonic tics at week 4
    End point description
    Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
    End point type
    Secondary
    End point timeframe
    baseline and week 4
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    40 [19]
    19 [20]
    Units: score on a scale
        arithmetic mean (standard deviation)
    -13.9 ± 15.7
    -15.5 ± 18.2
    Notes
    [19] - FAS Set 40 patients data were available for this enpoint, so 40 patients were analysed.
    [20] - FAS Set 19 patients data were available for this enpoint, so 19 patients were analysed.
    No statistical analyses for this end point

    Secondary: Clinical Global Impressions - Improvement at week 1

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    End point title
    		 Clinical Global Impressions - Improvement at week 1
    End point description
    Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
    End point type
    Secondary
    End point timeframe
    baseline and week 1
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [21]
    20 [22]
    Units: Number of Patients
        Responder
    5
    0
        Not Responder
    37
    20
    Notes
    [21] - FAS Set
    [22] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test with age group (6-9, 10-13, 14-17 years) stratification was performed. The Last Observation Carried Forward (LOCF) method was used to handle missing data.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1052
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Clinical Global Impressions - Improvement at week 2

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    End point title
    		 Clinical Global Impressions - Improvement at week 2
    End point description
    Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
    End point type
    Secondary
    End point timeframe
    baseline and week 2
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [23]
    20 [24]
    Units: Number of Patients
        Responder
    6
    1
        Not Responder
    36
    19
    Notes
    [23] - FAS Set
    [24] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test with age group (6-9, 10-13, 14-17 years) stratification was performed. The Last Observation Carried Forward (LOCF) method was used to handle missing data.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2274
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Clinical Global Impressions - Improvement at week 3

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    End point title
    		 Clinical Global Impressions - Improvement at week 3
    End point description
    Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
    End point type
    Secondary
    End point timeframe
    baseline and week 3
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [25]
    20 [26]
    Units: Number of Patients
        Responder
    5
    2
        Not Responder
    37
    18
    Notes
    [25] - FAS Set
    [26] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test with age group (6-9, 10-13, 14-17 years) stratification was performed. The Last Observation Carried Forward (LOCF) method was used to handle missing data.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7691
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Clinical Global Impressions - Improvement at week 4

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    End point title
    		 Clinical Global Impressions - Improvement at week 4
    End point description
    Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
    End point type
    Secondary
    End point timeframe
    baseline and week 4
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [27]
    20 [28]
    Units: Number of Patients
        Responder
    6
    7
        Not Responder
    36
    13
    Notes
    [27] - FAS Set
    [28] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Palcebo
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test with age group (6-9, 10-13, 14-17 years) stratification was performed. The Last Observation Carried Forward (LOCF) method was used to handle missing data.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0674
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Clinical Global Impressions - Improvement at week 6

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    End point title
    		 Clinical Global Impressions - Improvement at week 6
    End point description
    Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
    End point type
    Secondary
    End point timeframe
    baseline and week 6
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [29]
    20 [30]
    Units: Number of Patients
        Responder
    11
    7
        Not Responder
    31
    13
    Notes
    [29] - FAS Set
    [30] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test with age group (6-9, 10-13, 14-17 years) stratification was performed. The Last Observation Carried Forward (LOCF) method was used to handle missing data.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4944
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Clinical Global Impressions - Severity of Illness at week 1

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    End point title
    		 Clinical Global Impressions - Severity of Illness at week 1
    End point description
    Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.
    End point type
    Secondary
    End point timeframe
    baseline and week 1
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [31]
    20 [32]
    Units: Number of Patients
        Improved
    4
    0
        Unchanged
    38
    20
        Worsened
    0
    0
    Notes
    [31] - FAS Set
    [32] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test with age group (6-9, 10-13, 14-17 years) stratification was performed. The Last Observation Carried Forward (LOCF) method was used to handle missing data.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.162
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Clinical Global Impressions - Severity of Illness at week 2

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    End point title
    		 Clinical Global Impressions - Severity of Illness at week 2
    End point description
    Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.
    End point type
    Secondary
    End point timeframe
    baseline and week 2
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [33]
    20 [34]
    Units: Number of Patients
        Improved
    4
    1
        Unchanged
    37
    19
        Worsened
    1
    0
    Notes
    [33] - FAS Set
    [34] - FAS Set
    Statistical analysis title
    		 Placebo Vs Pramipexole
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test with age group (6-9, 10-13, 14-17 years) stratification was performed. The Last Observation Carried Forward (LOCF) method was used to handle missing data.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6375
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Clinical Global Impressions - Severity of Illness at week 3

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    End point title
    		 Clinical Global Impressions - Severity of Illness at week 3
    End point description
    Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.
    End point type
    Secondary
    End point timeframe
    baseline and week 3
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [35]
    20 [36]
    Units: Number of Patients
        Improved
    4
    3
        Unchanged
    37
    17
        Worsened
    1
    0
    Notes
    [35] - FAS Set
    [36] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test with age group (6-9, 10-13, 14-17 years) stratification was performed. The Last Observation Carried Forward (LOCF) method was used to handle missing data.
    Comparison groups
    Placebo v Pramipexole
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6625
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Clinical Global Impressions - Severity of Illness at week 4

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    End point title
    		 Clinical Global Impressions - Severity of Illness at week 4
    End point description
    Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.
    End point type
    Secondary
    End point timeframe
    baseline and week 4
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [37]
    20 [38]
    Units: Number of Patients
        Improved
    4
    4
        Unchanged
    38
    16
        Worsened
    0
    0
    Notes
    [37] - FAS Set
    [38] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test with age group (6-9, 10-13, 14-17 years) stratification was performed. The Last Observation Carried Forward (LOCF) method was used to handle missing data.
    Comparison groups
    Placebo v Pramipexole
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2664
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Clinical Global Impressions - Severity of Illness at week 6

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    End point title
    		 Clinical Global Impressions - Severity of Illness at week 6
    End point description
    Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.
    End point type
    Secondary
    End point timeframe
    baseline and week 6
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [39]
    20 [40]
    Units: Number of Patients
        Improved
    10
    4
        Unchanged
    32
    16
        Worsened
    0
    0
    Notes
    [39] - FAS Set
    [40] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test with age group (6-9, 10-13, 14-17 years) stratification was performed. The Last Observation Carried Forward (LOCF) method was used to handle missing data.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7302
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Patient Global Impression response at week 1

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    End point title
    		 Patient Global Impression response at week 1
    End point description
    Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
    End point type
    Secondary
    End point timeframe
    baseline and week 1
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [41]
    20 [42]
    Units: Number of Patients
        Responder
    7
    4
        Not Responder
    35
    16
    Notes
    [41] - FAS Set
    [42] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test with age group (6-9, 10-13, 14-17 years) stratification was performed. The Last Observation Carried Forward (LOCF) method was used to handle missing data.
    Comparison groups
    Placebo v Pramipexole
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7723
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Patient Global Impression response at week 2

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    End point title
    		 Patient Global Impression response at week 2
    End point description
    Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
    End point type
    Secondary
    End point timeframe
    baseline and week 2
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [43]
    20 [44]
    Units: Number of Patients
        Responder
    9
    6
        Not Responder
    33
    14
    Notes
    [43] - FAS Set
    [44] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test with age group (6-9, 10-13, 14-17 years) stratification was performed. The Last Observation Carried Forward (LOCF) method was used to handle missing data.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4852
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Patient Global Impression response at week 3

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    End point title
    		 Patient Global Impression response at week 3
    End point description
    Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
    End point type
    Secondary
    End point timeframe
    baseline and week 3
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [45]
    20 [46]
    Units: Number of Patients
        Responder
    7
    5
        Not Responder
    35
    15
    Notes
    [45] - FAS Set
    [46] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test with age group (6-9, 10-13, 14-17 years) stratification was performed. The Last Observation Carried Forward (LOCF) method was used to handle missing data.
    Comparison groups
    Placebo v Pramipexole
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4607
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Patient Global Impression response at week 4

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    End point title
    		 Patient Global Impression response at week 4
    End point description
    Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
    End point type
    Secondary
    End point timeframe
    baseline and week 4
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [47]
    20 [48]
    Units: Number of Patients
        Responder
    7
    4
        Not Responder
    35
    16
    Notes
    [47] - FAS Set
    [48] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test with age group (6-9, 10-13, 14-17 years) stratification was performed. The Last Observation Carried Forward (LOCF) method was used to handle missing data.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7723
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Patient Global Impression response at week 6

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    End point title
    		 Patient Global Impression response at week 6
    End point description
    Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
    End point type
    Secondary
    End point timeframe
    baseline and week 6
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    42 [49]
    20 [50]
    Units: Number of Patients
        Responder
    12
    6
        Not Responder
    30
    14
    Notes
    [49] - FAS Set
    [50] - FAS Set
    Statistical analysis title
    		 Pramipexole vs Placebo
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test with age group (6-9, 10-13, 14-17 years) stratification was performed. The Last Observation Carried Forward (LOCF) method was used to handle missing data.
    Comparison groups
    Pramipexole v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9389
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Clinically Significant Abnormalities

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    End point title
    		 Clinically Significant Abnormalities
    End point description
    Clinical significant abnormalities in vital signs (blood pressure, orthostatic reaction and pulse rate), height, weight, Tanner Staging, ECG, laboratory parameters, blood hematology and electrolyte assessments, serum chemistry and urine analyses. The Treated Set (TS) included all patients who were randomised, dispensed study medication and were documented to have taken at least one dose of study medication.
    End point type
    Secondary
    End point timeframe
    baseline and week 6
    End point values
    		 Pramipexole Placebo
    Number of subjects analysed
    40 [51]
    19 [52]
    Units: participants
        Phosphate - increase
    5
    2
        Bilirubin, total - increase
    1
    0
        Tachycardia
    1
    0
        Orthostatic hypotension
    4
    1
    Notes
    [51] - FAS Set 40 patients data were available, so 40 patients were analysed for this enpoint.
    [52] - FAS Set 19 patients data were available, so 19 patients were analysed for this enpoint.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All events with an onset after the first dose of study medication and up to a period of 48 hours after the last dose of study medication were assigned to the treatment period, upto 52 days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Pramipexole
    Reporting group description
    		 Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) was administered orally. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo tablets matching the Pramipexole tablets was administered orally.

    Serious adverse events
    		 Pramipexole Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pramipexole Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 43 (58.14%)
    13 / 20 (65.00%)
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 20 (5.00%)
         occurrences all number
    4
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 43 (27.91%)
    5 / 20 (25.00%)
         occurrences all number
    26
    7
    Dizziness
         subjects affected / exposed
    3 / 43 (6.98%)
    3 / 20 (15.00%)
         occurrences all number
    5
    3
    Somnolence
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 20 (5.00%)
         occurrences all number
    3
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 43 (9.30%)
    2 / 20 (10.00%)
         occurrences all number
    6
    2
    Pyrexia
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 20 (10.00%)
         occurrences all number
    2
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 43 (18.60%)
    2 / 20 (10.00%)
         occurrences all number
    10
    2
    Vomiting
         subjects affected / exposed
    5 / 43 (11.63%)
    0 / 20 (0.00%)
         occurrences all number
    7
    0
    Diarrhoea
         subjects affected / exposed
    3 / 43 (6.98%)
    2 / 20 (10.00%)
         occurrences all number
    3
    4
    Abdominal pain upper
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 20 (5.00%)
         occurrences all number
    5
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 43 (6.98%)
    3 / 20 (15.00%)
         occurrences all number
    3
    3
    Cough
         subjects affected / exposed
    3 / 43 (6.98%)
    2 / 20 (10.00%)
         occurrences all number
    3
    2
    Dyspnoea
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Psychiatric disorders
    Tic
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 20 (10.00%)
         occurrences all number
    1
    4
    Sleep disorder
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 20 (5.00%)
         occurrences all number
    4
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 20 (10.00%)
         occurrences all number
    2
    2
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 20 (5.00%)
         occurrences all number
    3
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Sep 2007
    • Provided a revised means to assess IQ of potential patients for entry into the study, updated the inclusion criteria accordingly. • Provided more specific instructions on the down titration process at the end of the treatment phase with study medication. • Expanded the list of restricted concomitant medications.
    06 Aug 2008
    • The trial duration was extended and centers in Germany were added in order to achieve full recruitment of planned sample size. • In order to optimize patient safety monitoring a Data Monitoring Committee was added and Visit 8 was required as a clinic visit for all patients. • Inclusion/exclusion criteria were modified. • Requirements, processes and other protocol activities were clarified: concomitant medications; dosing time; medication dispensing; PK samples; eye examination; YGTSS and CY-BOCS administration. • Logistical and/or administrative data were corrected: addition of EudraCT Number and trade name for pramipexole; change in personnel; total number of potential daily doses; typographical error on Day of Visit 8; logistical information for the trial medication supply; K-BIT2 for non-English speaking patients; Lab parameters; references.
    15 Apr 2009
    • Trial duration was extended due to an increase in sample size. • The number of study sites was revised to more accurately reflect the actual number of sites participating in the study. • Sample size was increased, as per the FDA’s Written Request to increase the power of the study to 85%. • Height was added as a safety parameter. • Inconsistencies in the protocol were corrected, and a clarification to the protocol was made. • Ethnicity was added to patient demographics to comply with FDA’s Written Request. • The restriction on the maximum number of patients enrolled per site was removed to improve patient recruitment. • Tanner Staging was added as an additional safety measure to be evaluated by the DMC. • Reference citations were added to the reference list.

    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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