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    Clinical Trial Results:
    A Double-blind, Placebo-controlled Study, Followed by an Open-label Extension Study Evaluating the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents with Irritability Associated with Autistic Disorder

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2015-001320-31
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    09 Oct 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    21 Jul 2016
    First version publication date
    03 Jun 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of FDS

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RIS-AUT-JPN-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01624675
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Pharmaceutical K.K
    Sponsor organisation address
    3-5-2 Nishi-kanda, Chiyoda-ku,, Tokyo, Japan, 101-0065
    Public contact
    Janssen Research and Development, Clinical Registry Group-JB BV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Janssen Research and Development, Clinical Registry Group-JB BV, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Oct 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the efficacy of risperidone compared with placebo in children and adolescents with irritability associated with autistic disorder.
    Protection of trial subjects
    Safety was evaluated based on the following variables: Adverse events; Clinical laboratory tests (hematology and serum chemistry); Vital sign measurements; Physical examinations; ECGs; Drug Induced Extrapyramidal Symptoms Scale questionnaire. Any clinically significant abnormalities persisting at the end of the study/early withdrawal were followed by the investigator until resolution or until a clinically stable endpoint was reached.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Aug 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 39
    Worldwide total number of subjects
    39
    EEA total number of subjects
    0
    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)
    28
    Adolescents (12-17 years)
    11
    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
    		 The study was conducted between 28 August 2012 and 9 October 2014 and recruited subjects from 18 study centers in Japan.

    Pre-assignment
    Screening details
    		 Thirty-nine subjects were enrolled and randomly assigned to the risperidone group or placebo group (n=18) in double blind period.

    Period 1
    Period 1 title
    Overall Study (Double Blind+Open label) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Risperidone
    Arm description
    		 Subjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing >= 45 kg was 3.0 mg. For subjects weighing >=45 kg, the maximum daily dose was 3.0 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Risperidone
    Investigational medicinal product code
    Other name
    Risperdal
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. For subjects weighing >=45 kg, the maximum daily dose was 3.0 mg.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo matching with risperidone from Day 1 up to Week 8.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo matching with risperidone from Day 1 up to Week 8.

    Arm title
    		 Open Label Risperidone
    Arm description
    		 Subjects who completed the period 1 (either Risperidone Arm or Placebo Arm) and subjects who were eligible as per Investigator’s discretion continued to open label period 2. Subjects < 20 kg received risperidone 0.25 mg/day up to Day 4. On Day 4, dose was increased to 0.5 mg/day. Dose was titrated in increments of 0.25 mg/day up to 1.0 mg/Day, at the regular study visit thereafter till Week 48. Subjects weighing >=20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was increased to 1.0 mg/day. Dose was titrated in increments of 0.5 mg/day up to 2.5 mg/Day, at the regular study visit thereafter till Week 48. The maximum daily dose for subject weighing >=45 kg was 3.0 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Risperidone
    Investigational medicinal product code
    Other name
    Risperdal
    Pharmaceutical forms
    Oral solution, Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject who completed the period 1 (either Risperidone Arm or Placebo Arm) and participants who were eligible as per Investigator’s discretion continued to open label period 2. Participants < 20 kg received risperidone 0.25 mg/day up to Day 4. On Day 4, dose was increased to 0.5 mg/day. Dose was titrated in increments of 0.25 mg/day up to 1.0 mg/Day, at the regular study visit thereafter till Week 48. Participants weighing >=20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was increased to 1.0 mg/day. Dose was titrated in increments of 0.5 mg/day up to 2.5 mg/Day, at the regular study visit thereafter till Week 48. The maximum daily dose for participant weighing >=45 kg was 3.0 mg.

    Number of subjects in period 1
    		Risperidone Placebo Open Label Risperidone
    Started
    21
    18
    35
    Completed
    18
    11
    26
    Not completed
    3
    7
    9
         Adverse event, non-fatal
    -
    -
    1
         Not Defined
    -
    -
    1
         non-compliance with the study drug
    -
    -
    3
         Violated Eligibility Criteria
    -
    -
    1
         Consent withdrawn by subject
    2
    -
    -
         Lack of efficacy
    1
    7
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study (Double Blind+Open label)
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study (Double Blind+Open label) Total
    Number of subjects
    		 39 39
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 28 28
        Adolescents (12-17 years)
    		 11 11
        Adults (18-64 years)
    		 0 0
        From 65 to 84 years
    		 0 0
        85 years and over
    		 0 0
    Title for Gender
    Units: subjects
        Female
    		 9 9
        Male
    		 30 30

    End points

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    End points reporting groups
    Reporting group title
    Risperidone
    Reporting group description
    		 Subjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing >= 45 kg was 3.0 mg. For subjects weighing >=45 kg, the maximum daily dose was 3.0 mg.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matching with risperidone from Day 1 up to Week 8.

    Reporting group title
    Open Label Risperidone
    Reporting group description
    		 Subjects who completed the period 1 (either Risperidone Arm or Placebo Arm) and subjects who were eligible as per Investigator’s discretion continued to open label period 2. Subjects < 20 kg received risperidone 0.25 mg/day up to Day 4. On Day 4, dose was increased to 0.5 mg/day. Dose was titrated in increments of 0.25 mg/day up to 1.0 mg/Day, at the regular study visit thereafter till Week 48. Subjects weighing >=20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was increased to 1.0 mg/day. Dose was titrated in increments of 0.5 mg/day up to 2.5 mg/Day, at the regular study visit thereafter till Week 48. The maximum daily dose for subject weighing >=45 kg was 3.0 mg.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set (FAS) included all participants who were randomized and received study drug and have efficacy data at baseline and at least 1 post-baseline time point.

    Primary: Change From Baseline in the Aberrant Behavior Checklist−Japanese Version (ABC-J) Irritability Subscale Scores at Week 8

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    End point title
    		 Change From Baseline in the Aberrant Behavior Checklist−Japanese Version (ABC-J) Irritability Subscale Scores at Week 8 [1]
    End point description
    The ABC-J consists of 58 items divided into 5 subscales: Irritability, Lethargy and Social withdrawal, Stereotypic behavior, Hyperactivity/Noncompliance, and Inappropriate speech. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition. Missing data was calculated by last observation carried forward (LOCF) method.
    End point type
    Primary
    End point timeframe
    Baseline and Endpoint (=Week 8)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specific arms only
    End point values
    		 Risperidone Placebo
    Number of subjects analysed
    21 [2]
    18 [3]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline
    28.2 ( 6.36 )
    27.5 ( 5.26 )
        Change at Endpoint
    -9.7 ( 7.29 )
    -2.8 ( 6.62 )
    Notes
    [2] - FAS population
    [3] - FAS population
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Risperidone v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.6
         upper limit
    		 -2.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.23
    Notes
    [4] - p-value is analysed by using analysis of covariance (ANCOVA) model including treatment group as a fixed factor and baseline score as a covariate.

    Secondary: Change From Baseline in the Aberrant Behavior Checklist−Japanese Version (ABC-J) Irritability Subscale Scores at Week 2, 4 and 6 of Double Blind Phase

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    End point title
    		 Change From Baseline in the Aberrant Behavior Checklist−Japanese Version (ABC-J) Irritability Subscale Scores at Week 2, 4 and 6 of Double Blind Phase [5]
    End point description
    The ABC-J consists of 58 items divided into 5 subscales: Irritability, Lethargy and Social withdrawal, Stereotypic behavior, Hyperactivity/Noncompliance, and Inappropriate speech. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition. Missing data was calculated by LOCF method.
    End point type
    Secondary
    End point timeframe
    Week 2, 4 and 6 of Double-blind Phase
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specific arms only
    End point values
    		 Risperidone Placebo
    Number of subjects analysed
    21 [6]
    18 [7]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Change at Week 2
    -7.7 ( 8.33 )
    -1.4 ( 4.07 )
        Change at Week 4
    -9.5 ( 8.42 )
    -1.2 ( 5.92 )
        Change at Week 6
    -9 ( 7.18 )
    -2.1 ( 6.51 )
    Notes
    [6] - FAS population
    [7] - FAS population
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Aberrant Behavior Checklist−Japanese Version (ABC-J) Irritability Subscale Scores at Week 2, 4, 8, 16, 24, 32, 40 and 48 of Open label Phase

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    End point title
    		 Change From Baseline in the Aberrant Behavior Checklist−Japanese Version (ABC-J) Irritability Subscale Scores at Week 2, 4, 8, 16, 24, 32, 40 and 48 of Open label Phase [8]
    End point description
    The ABC-J consists of 58 items divided into 5 subscales: Irritability, Lethargy and Social withdrawal, Stereotypic behavior, Hyperactivity/Noncompliance, and Inappropriate speech. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition. Missing data was calculated by LOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 16, 24, 32, 40 and 48 of Open Label Phase
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specific arms only
    End point values
    		 Open Label Risperidone
    Number of subjects analysed
    35 [9]
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline
    26.3 ( 8.4 )
        Change at Week 2
    -9.5 ( 8.32 )
        Change at Week 4
    -11.7 ( 8.93 )
        Change at Week 8
    -12.5 ( 9.44 )
        Change at Week 16
    -12.5 ( 9.9 )
        Change at Week 24
    -12.6 ( 9.64 )
        Change at Week 32
    -12.2 ( 9.7 )
        Change at Week 40
    -13.2 ( 10.19 )
        Change at Endpoint (Week 48)
    -13.3 ( 10.27 )
    Notes
    [9] - FAS population
    No statistical analyses for this end point

    Secondary: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3, 4, 6 and 8 of Double Blind Phase

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    End point title
    		 Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3, 4, 6 and 8 of Double Blind Phase [10]
    End point description
    The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening. Missing data was calculated by LOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 3, 4, 6 and 8 of Double Blind Phase
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specific arms only
    End point values
    		 Risperidone Placebo
    Number of subjects analysed
    21 [11]
    18 [12]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline
    4.6 ( 0.81 )
    4.2 ( 0.55 )
        Change at Week 1
    0 ( 0.22 )
    0 ( 0 )
        Change at Week 2
    -0.1 ( 0.36 )
    0 ( 0.34 )
        Change at Week 3
    -0.2 ( 0.4 )
    0.1 ( 0.58 )
        Change at Week 4
    -0.2 ( 0.4 )
    0.1 ( 0.68 )
        Change at Week 6
    -0.1 ( 0.48 )
    0.2 ( 0.71 )
        Change at Endpoint (Week 8)
    -0.1 ( 0.48 )
    0.2 ( 0.71 )
    Notes
    [11] - FAS population
    [12] - FAS population
    No statistical analyses for this end point

    Secondary: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3, 4, 8, 16, 24, 32, 40 and 48 of Open-label-Phase

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    End point title
    		 Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3, 4, 8, 16, 24, 32, 40 and 48 of Open-label-Phase [13]
    End point description
    The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening. Missing data was calculated by LOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 3, 4, 8, 16, 24, 32, 40 and 48 of Open-Label Phase
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specific arms only
    End point values
    		 Open Label Risperidone
    Number of subjects analysed
    35 [14]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline
    4.5 ( 0.85 )
        Change at Week 1
    -0.3 ( 0.67 )
        Change at Week 2
    -0.3 ( 0.68 )
        Change at Week 3
    -0.5 ( 0.78 )
        Change at Week 4
    -0.7 ( 0.84 )
        Change at Week 8
    -0.7 ( 0.87 )
        Change at Week 16
    -0.7 ( 0.87 )
        Change at Week 24
    -0.7 ( 0.93 )
        Change at Week 32
    -0.7 ( 0.93 )
        Change at Week 40
    -0.7 ( 1 )
        Change at Endpoint (Week 48)
    -0.7 ( 1.04 )
    Notes
    [14] - FAS population
    No statistical analyses for this end point

    Secondary: Change From Baseline in Children's Global Assessment Scale (C-GAS) Score at Week 4 and 8 of Double Blind Phase

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    End point title
    		 Change From Baseline in Children's Global Assessment Scale (C-GAS) Score at Week 4 and 8 of Double Blind Phase [15]
    End point description
    The C-GAS rates the patient's general psychological and social functioning on scores ranging from 1 through 100. Lower scores (range 1-10) mean that the patient needs constant supervision; higher scores (range 91-100) mean that the patient has a superior functioning in all areas. Missing data was calculated by LOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4 and 8 of Double Blind Phase
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specific arms only
    End point values
    		 Risperidone Placebo
    Number of subjects analysed
    21 [16]
    18 [17]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline
    41.9 ( 14.69 )
    45.4 ( 12.82 )
        Change at Week 4
    3.8 ( 7.74 )
    -1.2 ( 6.98 )
        Change at endpoint (Week 8)
    5.8 ( 7.67 )
    -1.9 ( 7.22 )
    Notes
    [16] - FAS population
    [17] - FAS population
    No statistical analyses for this end point

    Secondary: Change From Baseline in Children's Global Assessment Scale (C-GAS) at Week 4, 8, 16, 24, 32, 40 and 48 of Open Label Phase

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    End point title
    		 Change From Baseline in Children's Global Assessment Scale (C-GAS) at Week 4, 8, 16, 24, 32, 40 and 48 of Open Label Phase [18]
    End point description
    The C-GAS rates the patient's general psychological and social functioning on scores ranging from 1 through 100. Lower scores (range 1-10) mean that the patient needs constant supervision; higher scores (range 91-100) mean that the patient has a superior functioning in all areas. Missing data was calculated by LOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 8, 16, 24, 32, 40 and 48 of Open label Phase
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specific arms only
    End point values
    		 Open Label Risperidone
    Number of subjects analysed
    35 [19]
    Units: Units on a Scale
    arithmetic mean (standard deviation)
        Baseline
    42.1 ( 13.88 )
        Change at Week 4
    7.9 ( 9.19 )
        Change at Week 8
    9.3 ( 9.67 )
        Change at Week 16
    10.5 ( 10.78 )
        Change at Week 24
    10.4 ( 11.17 )
        Change at Week 32
    10.6 ( 11.94 )
        Change at Week 40
    10.5 ( 13.69 )
        Change at Endpoint (Week 48)
    10.6 ( 13.61 )
    Notes
    [19] - FAS population
    No statistical analyses for this end point

    Secondary: Clinical Global Impression−Change (CGI-C) Score at Week 1, 2, 3, 4, 6 and 8 of Double Blind Phase

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    End point title
    		 Clinical Global Impression−Change (CGI-C) Score at Week 1, 2, 3, 4, 6 and 8 of Double Blind Phase [20]
    End point description
    The CGI-C assesses the patient's condition on the basis of the rater's impression, on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse). Missing data was calculated by LOCF method.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 3, 4, 6 and 8 of double blind Phase
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specific arms only
    End point values
    		 Risperidone Placebo
    Number of subjects analysed
    21 [21]
    18 [22]
    Units: Number of Subjects
        Week 1: Very much improved
    0
    0
        Week 1: Much improved
    1
    0
        Week 1: Minimally improved
    8
    1
        Week 1: No change
    12
    15
        Week 1: Minimally worse
    0
    1
        Week 1: Much worse
    0
    1
        Week 1: Very much worse
    0
    0
        Week 2: Very much improved
    0
    0
        Week 2: Much improved
    6
    0
        Week 2: Minimally improved
    8
    2
        Week 2: No change
    7
    11
        Week 2: Minimally worse
    0
    3
        Week 2: Much worse
    0
    2
        Week 2: Very much worse
    0
    0
        Week 3: Very much improved
    0
    0
        Week 3: Much improved
    5
    1
        Week 3: Minimally improved
    8
    3
        Week 3: No change
    5
    7
        Week 3: Minimally worse
    2
    0
        Week 3: Much worse
    1
    7
        Week 3: Very much worse
    0
    0
        Week 4: Very much improved
    0
    0
        Week 4: Much improved
    6
    0
        Week 4: Minimally improved
    9
    3
        Week 4: No change
    5
    6
        Week 4: Minimally worse
    0
    2
        Week 4: Much worse
    1
    7
        Week 4: Very much worse
    0
    0
        Week 6: Very much improved
    1
    0
        Week 6: Much improved
    4
    0
        Week 6: Minimally improved
    9
    4
        Week 6: No change
    5
    5
        Week 6: Minimally worse
    1
    1
        Week 6: Much worse
    1
    8
        Week 6: Very much worse
    0
    0
        Endpoint (Week 8): Very much improved
    1
    0
        Endpoint (Week 8): Much improved
    2
    0
        Endpoint (Week 8): Minimally improved
    11
    5
        Endpoint (Week 8): No change
    5
    3
        Endpoint (Week 8): Minimally worse
    1
    2
        Endpoint (Week 8): Much worse
    1
    8
        Endpoint (Week 8): Very much worse
    0
    0
    Notes
    [21] - FAS population
    [22] - FAS population
    No statistical analyses for this end point

    Secondary: Clinical Global Impression−Change (CGI-C) at Week 1, 2, 3, 4, 8, 16, 24, 32, 40 and 48 of Open-Label Phase

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    End point title
    		 Clinical Global Impression−Change (CGI-C) at Week 1, 2, 3, 4, 8, 16, 24, 32, 40 and 48 of Open-Label Phase [23]
    End point description
    The CGI-C assesses the patient's condition on the basis of the rater's impression, on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse). Missing data was calculated by LOCF method.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 3, 4, 8, 16, 24, 32, 40 and 48 of Open-Label Phase
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specific arms only
    End point values
    		 Open Label Risperidone
    Number of subjects analysed
    35 [24]
    Units: Number of Subjects
        Week 1: Very much improved
    2
        Week 1: Much improved
    2
        Week 1: Minimally improved
    18
        Week 1: No change
    9
        Week 1: Minimally worse
    2
        Week 1: Much worse
    2
        Week 1: Very much worse
    0
        Week 2: Very much improved
    2
        Week 2: Much improved
    5
        Week 2: Minimally improved
    19
        Week 2: No change
    7
        Week 2: Minimally worse
    2
        Week 2: Much worse
    0
        Week 2: Very much worse
    0
        Week 3: Very much improved
    2
        Week 3: Much improved
    9
        Week 3: Minimally improved
    17
        Week 3: No change
    6
        Week 3: Minimally worse
    1
        Week 3: Much worse
    0
        Week 3: Very much worse
    0
        Week 4: Very much improved
    2
        Week 4: Much improved
    11
        Week 4: Minimally improved
    15
        Week 4: No change
    6
        Week 4: Minimally worse
    1
        Week 4: Much worse
    0
        Week 4: Very much worse
    0
        Week 8: Very much improved
    1
        Week 8: Much improved
    14
        Week 8: Minimally improved
    13
        Week 8: No change
    5
        Week 8: Minimally worse
    2
        Week 8: Much worse
    0
        Week 8: Very much worse
    0
        Week 16: Very much improved
    1
        Week 16: Much improved
    12
        Week 16: Minimally improved
    16
        Week 16: No change
    4
        Week 16: Minimally worse
    2
        Week 16: Much worse
    0
        Week 16: Very much worse
    0
        Week 24: Very much improved
    1
        Week 24: Much improved
    12
        Week 24: Minimally improved
    13
        Week 24: No change
    6
        Week 24: Minimally worse
    3
        Week 24: Much worse
    0
        Week 24: Very much worse
    0
        Week 32: Very much improved
    0
        Week 32: Much improved
    13
        Week 32: Minimally improved
    14
        Week 32: No change
    4
        Week 32: Minimally worse
    4
        Week 32: Much worse
    0
        Week 32: Very much worse
    0
        Week 40: Very much improved
    2
        Week 40: Much improved
    11
        Week 40: Minimally improved
    12
        Week 40: No change
    5
        Week 40: Minimally worse
    5
        Week 40: Much worse
    0
        Week 40: Very much worse
    0
        Endpoint (Week 48): Very much improved
    1
        Endpoint (Week 48): Much improved
    11
        Endpoint (Week 48): Minimally improved
    13
        Endpoint (Week 48): No change
    4
        Endpoint (Week 48): Minimally worse
    6
        Endpoint (Week 48): Much worse
    0
        Endpoint (Week 48): Very much worse
    0
    Notes
    [24] - FAS population
    No statistical analyses for this end point

    Secondary: Parent Satisfaction Questionnaire (PSQ): Question 1 at Week 1, 2, 3, 4, 6 and 8 of Double Blind Period

    		 Close Top of page
    End point title
    		 Parent Satisfaction Questionnaire (PSQ): Question 1 at Week 1, 2, 3, 4, 6 and 8 of Double Blind Period [25]
    End point description
    The PSQ evaluates the caregiver's satisfaction with the study drug. Caregivers were requested to answer question (Ques) 1: Overall, how pleased have you been with the current study medication for your child’s autistic disorder symptoms. Number of participants at each category for each question were reported. Missing data was calculated by LOCF method.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 3, 4, 6 and 8 of Double-blind Phase
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specific arms only
    End point values
    		 Risperidone Placebo
    Number of subjects analysed
    21 [26]
    18 [27]
    Units: Number of subjects
        Week 1: Ques 1: Extremely displeased
    0
    0
        Week 1: Ques 1: Very displeased
    2
    2
        Week 1: Ques 1: A bit displeased
    3
    9
        Week 1: Ques 1: Pleased
    13
    6
        Week 1: Ques 1: Very pleased
    3
    1
        Week 1: Ques 1: Extremely pleased
    0
    0
        Week 2: Ques 1: Extremely displeased
    0
    1
        Week 2: Ques 1: Very displeased
    2
    3
        Week 2: Ques 1: A bit displeased
    4
    9
        Week 2: Ques 1: Pleased
    12
    5
        Week 2: Ques 1: Very pleased
    2
    0
        Week 2: Ques 1: Extremely pleased
    1
    0
        Week 3: Ques 1: Extremely displeased
    1
    1
        Week 3: Ques 1: Very displeased
    0
    7
        Week 3: Ques 1: A bit displeased
    3
    3
        Week 3: Ques 1: Pleased (n=28)
    12
    5
        Week 3: Ques 1: Very pleased
    5
    2
        Week 3: Ques 1: Extremely pleased
    0
    0
        Week 4: Ques 1: Extremely displeased
    1
    3
        Week 4: Ques 1: Very displeased
    0
    2
        Week 4: Ques 1: A bit displeased
    5
    5
        Week 4: Ques 1: Pleased
    10
    7
        Week 4: Ques 1: Very pleased
    5
    1
        Week 4: Ques 1: Extremely pleased
    0
    0
        Week 6: Ques 1: Extremely displeased
    0
    3
        Week 6: Ques 1: Very displeased
    1
    1
        Week 6: Ques 1: A bit displeased
    8
    7
        Week 6: Ques 1: Pleased
    9
    5
        Week 6: Ques 1: Very pleased
    3
    2
        Week 6: Ques 1: Extremely pleased
    0
    0
        Endpoint (Week 8): Ques 1: Extremely displeased
    0
    3
        Endpoint (Week 8): Ques 1: Very displeased
    1
    4
        Endpoint (Week 8): Ques 1: A bit displeased
    8
    5
        Endpoint (Week 8): Ques 1: Pleased
    10
    3
        Endpoint (Week 8): Ques 1: Very pleased
    2
    3
        Endpoint (Week 8): Ques 1: Extremely pleased
    0
    0
    Notes
    [26] - FAS population
    [27] - FAS Population
    No statistical analyses for this end point

    Secondary: Parent Satisfaction Questionnaire (PSQ): Question 2 at Week 1, 2, 3, 4, 6 and 8 of Double Blind Period

    		 Close Top of page
    End point title
    		 Parent Satisfaction Questionnaire (PSQ): Question 2 at Week 1, 2, 3, 4, 6 and 8 of Double Blind Period [28]
    End point description
    The PSQ evaluates the caregiver's satisfaction with the study drug. Caregivers were requested to answer question (Ques) 2: How much has your child benefited from the current study medication for his/her autistic disorder symptoms. Number of participants at each category for each question were reported. Missing data was calculated by LOCF method.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 3, 4, 6 and 8 of Double-blind Phase
    Notes
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specific arms only
    End point values
    		 Risperidone Placebo
    Number of subjects analysed
    21 [29]
    18 [30]
    Units: Number of subjects
        Week 1: Ques 2: A little bit
    1
    10
        Week 1: Ques 2: Not at all
    12
    7
        Week 1: Ques 2: Some
    3
    1
        Week 1: Ques 2: A lot
    0
    0
        Week 2: Ques 2: Not at all
    3
    11
        Week 2: Ques 2: A little bit
    13
    6
        Week 2: Ques 2: Some
    4
    1
        Week 2: Ques 2: A lot
    1
    0
        Week 3: Ques 2: Not at all
    2
    10
        Week 3: Ques 2: A little bit
    15
    6
        Week 3: Ques 2: Some
    4
    2
        Week 3: Ques 2: A lot
    0
    0
        Week 4: Ques 2: Not at all
    3
    10
        Week 4: Ques 2: A little bit
    13
    6
        Week 4: Ques 2: Some
    5
    2
        Week 4: Ques 2: A lot
    0
    0
        Week 6: Ques 2: Not at all
    2
    10
        Week 6: Ques 2: A little bit
    15
    5
        Week 6: Ques 2: Some
    4
    3
        Week 6: Ques 2: A lot
    0
    0
        Endpoint (Week 8): Ques 2: Not at all
    2
    11
        Endpoint (Week 8): Ques 2: A little bit
    16
    5
        Endpoint (Week 8): Ques 2: Some
    3
    2
        Endpoint (Week 8): Ques 2: A lot
    0
    0
    Notes
    [29] - FAS population
    [30] - FAS population
    No statistical analyses for this end point

    Secondary: Parent Satisfaction Questionnaire (PSQ): Question 3 at Week 1, 2, 3, 4, 6 and 8 of Double Blind Period

    		 Close Top of page
    End point title
    		 Parent Satisfaction Questionnaire (PSQ): Question 3 at Week 1, 2, 3, 4, 6 and 8 of Double Blind Period [31]
    End point description
    The PSQ evaluates the caregiver's satisfaction with the study drug. Caregivers were requested to answer question (Ques) 3: Would you recommend the current study medication for your child’s symptoms to someone else with same condition. Number of participants at each category for each question were reported. Missing data was calculated by LOCF method.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 3, 4, 6 and 8 of Double-blind Phase
    Notes
    [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specific arms only
    End point values
    		 Risperidone Placebo
    Number of subjects analysed
    21 [32]
    18 [33]
    Units: Number of subjects
        Week 1: Ques 3: No
    1
    3
        Week 1: Ques 3: Unsure
    17
    14
        Week 1: Ques 3: Yes
    3
    1
        Week 2: Ques 3: No
    1
    3
        Week 2: Ques 3: Unsure
    17
    14
        Week 2: Ques 3: Yes
    3
    1
        Week 3: Ques 3: No
    1
    5
        Week 3: Ques 3: Unsure
    15
    10
        Week 3: Ques 3: Yes
    5
    3
        Week 4: Ques 3: No
    1
    4
        Week 4: Ques 3: Unsure
    16
    9
        Week 4: Ques 3: Yes
    4
    5
        Week 6: Ques 3: No
    1
    5
        Week 6: Ques 3: Unsure
    16
    9
        Week 6: Ques 3: Yes
    4
    4
        Endpoint (Week 8): Ques 3: No
    1
    5
        Endpoint (Week 8): Ques 3: Unsure
    16
    8
        Endpoint (Week 8): Ques 3: Yes
    4
    5
    Notes
    [32] - FAS population
    [33] - FAS population
    No statistical analyses for this end point

    Secondary: Parent Satisfaction Questionnaire (PSQ): Question 1 at Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 40 and 42 of Open-label Phase

    		 Close Top of page
    End point title
    		 Parent Satisfaction Questionnaire (PSQ): Question 1 at Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 40 and 42 of Open-label Phase [34]
    End point description
    The PSQ evaluates the caregiver's satisfaction with the study drug. Caregivers were requested to answer question (Ques) 1: Overall, how pleased have you been with the current study medication for your child’s autistic disorder symptoms. Missing data was calculated by LOCF method.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 40 and 42 of Open-label Phase
    Notes
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specific arms only
    End point values
    		 Open Label Risperidone
    Number of subjects analysed
    35 [35]
    Units: Number of subjects
        Week 1: Ques 1: Extremely displeased
    2
        Week 1: Ques 1: Very displeased
    1
        Week 1: Ques 1: A bit displeased
    8
        Week 1: Ques 1: Pleased (n=34)
    15
        Week 1: Ques 1: Very pleased (n=34)
    8
        Week 1: Ques 1: Extremely pleased
    1
        Week 2: Ques 1: Extremely displeased
    0
        Week 2: Ques 1: Very displeased
    2
        Week 2: Ques 1: A bit displeased
    9
        Week 2: Ques 1: Pleased
    16
        Week 2: Ques 1: Very pleased
    7
        Week 2: Ques 1: Extremely pleased
    1
        Week 3: Ques 1: Extremely displeased
    0
        Week 3: Ques 1: Very displeased
    2
        Week 3: Ques 1: A bit displeased
    4
        Week 3: Ques 1: Pleased
    15
        Week 3: Ques 1: Very pleased
    12
        Week 3: Ques 1: Extremely pleased
    2
        Week 4: Ques 1: Extremely displeased
    0
        Week 4: Ques 1: Very displeased
    0
        Week 4: Ques 1: A bit displeased
    7
        Week 4: Ques 1: Pleased
    16
        Week 4: Ques 1: Very pleased
    10
        Week 4: Ques 1: Extremely pleased
    2
        Week 8: Ques 1: Extremely displeased
    0
        Week 8: Ques 1: Very displeased
    1
        Week 8: Ques 1: A bit displeased
    5
        Week 8: Ques 1: Pleased
    15
        Week 8: Ques 1: Very pleased
    10
        Week 8: Ques 1: Extremely pleased
    4
        Week 12: Ques 1: Extremely displeased
    0
        Week 12: Ques 1: Very displeased
    1
        Week 12: Ques 1: A bit displeased
    6
        Week 12: Ques 1: Pleased
    16
        Week 12: Ques 1: Very pleased
    8
        Week 12: Ques 1: Extremely pleased
    4
        Week 16: Ques 1: Extremely displeased
    0
        Week 16: Ques 1: Very displeased
    1
        Week 16: Ques 1: A bit displeased
    5
        Week 16: Ques 1: Pleased
    19
        Week 16: Ques 1: Very pleased
    7
        Week 16: Ques 1: Extremely pleased
    3
        Week 20: Ques 1: Extremely displeased
    0
        Week 20: Ques 1: Very displeased
    1
        Week 20: Ques 1: A bit displeased
    7
        Week 20: Ques 1: Pleased
    14
        Week 20: Ques 1: Very pleased
    10
        Week 20: Ques 1: Extremely pleased
    3
        Week 24: Ques 1: Extremely displeased
    0
        Week 24: Ques 1: Very displeased
    2
        Week 24: Ques 1: A bit displeased
    8
        Week 24: Ques 1: Pleased
    13
        Week 24: Ques 1: Very pleased
    8
        Week 24: Ques 1: Extremely pleased
    4
        Week 28: Ques 1: Extremely displeased
    0
        Week 28: Ques 1: Very displeased
    1
        Week 28: Ques 1: A bit displeased
    8
        Week 28: Ques 1: Pleased
    12
        Week 28: Ques 1: Very pleased
    11
        Week 28: Ques 1: Extremely pleased
    3
        Week 32: Ques 1: Extremely displeased
    0
        Week 32: Ques 1: Very displeased
    2
        Week 32: Ques 1: A bit displeased
    6
        Week 32: Ques 1: Pleased
    16
        Week 32: Ques 1: Very pleased
    8
        Week 32: Ques 1: Extremely pleased
    3
        Week 36: Ques 1: Extremely displeased
    0
        Week 36: Ques 1: Very displeased
    1
        Week 36: Ques 1: A bit displeased
    7
        Week 36: Ques 1: Pleased
    17
        Week 36: Ques 1: Very pleased
    8
        Week 36: Ques 1: Extremely pleased
    2
        Week 40: Ques 1: Extremely displeased
    0
        Week 40: Ques 1: Very displeased
    1
        Week 40: Ques 1: A bit displeased
    7
        Week 40: Ques 1: Pleased
    14
        Week 40: Ques 1: Very pleased
    10
        Week 40: Ques 1: Extremely pleased
    3
        Week 44: Ques 1: Extremely displeased
    1
        Week 44: Ques 1: Very displeased
    1
        Week 44: Ques 1: A bit displeased
    5
        Week 44: Ques 1: Pleased
    20
        Week 44: Ques 1: Very pleased
    6
        Week 44: Ques 1: Extremely pleased
    2
        Endpoint (Week 48): Ques 1: Extremely displeased
    0
        Endpoint (Week 48: Ques 1: Very displeased)
    2
        Endpoint (Week 48: Ques 1: A bit displeased)
    6
        Endpoint (Week 48): Ques 1: Pleased (n=26)
    15
        Endpoint (Week 48): Ques 1: Very pleased
    9
        Endpoint (Week 48: Ques 1): Extremely pleased
    3
    Notes
    [35] - FAS population
    No statistical analyses for this end point

    Secondary: Parent Satisfaction Questionnaire (PSQ): Question 2 at Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 40 and 42 of Open-label Phase

    		 Close Top of page
    End point title
    		 Parent Satisfaction Questionnaire (PSQ): Question 2 at Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 40 and 42 of Open-label Phase [36]
    End point description
    The PSQ evaluates the caregiver's satisfaction with the study drug. Caregivers were requested to answer question (Ques) 2: How much has your child benefited from the current study medication for his/her autistic disorder symptoms. Missing data was calculated by LOCF method.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 40 and 42 of Open-label Phase
    Notes
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specific arms only
    End point values
    		 Open Label Risperidone
    Number of subjects analysed
    35 [37]
    Units: Number of subject
        Week 1: Ques 2: Not at all
    5
        Week 1: Ques 2: A little bit
    19
        Week 1: Ques 2: Some
    9
        Week 1: Ques 2: A lot
    2
        Week 2: Ques 2: Not at all
    4
        Week 2: Ques 2: A little bit
    19
        Week 2: Ques 2: Some
    10
        Week 2: Ques 2: A lot
    2
        Week 3: Ques 2: Not at all
    5
        Week 3: Ques 2: A little bit
    13
        Week 3: Ques 2: Some
    13
        Week 3: Ques 2: A lot
    4
        Week 4: Ques 2: Not at all
    4
        Week 4: Ques 2: A little bit
    14
        Week 4: Ques 2: Some
    13
        Week 4: Ques 2: A lot
    4
        Week 8: Ques 2: Not at all
    4
        Week 8: Ques 2: A little bit
    12
        Week 8: Ques 2: Some
    14
        Week 8: Ques 2: A lot
    5
        Week 12: Ques 2: Not at all
    4
        Week 12: Ques 2: A little bit
    6
        Week 12: Ques 2: Some
    11
        Week 12: Ques 2: A lot
    4
        Week 16: Ques 2: Not at all
    3
        Week 16: Ques 2: A little bit
    16
        Week 16: Ques 2: Some
    14
        Week 16: Ques 2: A lot
    2
        Week 20: Ques 2: Not at all
    3
        Week 20: Ques 2: A little bit
    14
        Week 20: Ques 2: Some
    15
        Week 20: Ques 2: A lot
    3
        Week 24: Ques 2: Not at all
    4
        Week 24: Ques 2: A little bit
    16
        Week 24: Ques 2: Some
    12
        Week 24: Ques 2: A lot
    3
        Week 28: Ques 2: Not at all
    4
        Week 28: Ques 2: A little bit
    12
        Week 28: Ques 2: Some
    15
        Week 28: Ques 2: A lot
    4
        Week 32: Ques 2: Not at all
    3
        Week 32: Ques 2: A little bit
    18
        Week 32: Ques 2: Some
    11
        Week 32: Ques 2: A lot
    3
        Week 36: Ques 2: Not at all
    2
        Week 36: Ques 2: A little bit
    17
        Week 36: Ques 2: Some
    13
        Week 36: Ques 2: A lot
    3
        Week 40: Ques 2: Not at all
    2
        Week 40: Ques 2: A little bit
    18
        Week 40: Ques 2: Some
    12
        Week 40: Ques 2: A lot
    3
        Week 44: Ques 2: Not at all
    4
        Week 44: Ques 2: A little bit
    17
        Week 44: Ques 2: Some
    11
        Week 44: Ques 2: A lot
    3
        Endpoint (Week 48): Ques 2: Not at all
    3
        Endpoint (Week 48): Ques 2: A little bit
    16
        Endpoint (Week 48): Ques 2: Some
    13
        Endpoint (Week 48): Ques 2: A lot (n=26)
    3
    Notes
    [37] - FAS population
    No statistical analyses for this end point

    Secondary: Parent Satisfaction Questionnaire (PSQ): Question 3 at Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 40 and 42 of Open-label Phase

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    End point title
    		 Parent Satisfaction Questionnaire (PSQ): Question 3 at Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 40 and 42 of Open-label Phase [38]
    End point description
    The PSQ evaluates the caregiver's satisfaction with the study drug. Caregivers were requested to answer question (Ques) 3: Would you recommend the current study medication for your child’s symptoms to someone else with same condition. Number of participants at each category for each question were reported. Missing value was calculated by LOCF method.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 40 and 42 of Open-label Phase
    Notes
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specific arms only
    End point values
    		 Open Label Risperidone
    Number of subjects analysed
    35 [39]
    Units: Number of subjects
        Week 1: Ques 3: No
    2
        Week 1: Ques 3: Unsure
    22
        Week 1: Ques 3: Less
    11
        Week 2: Ques 3: No
    0
        Week 2: Ques 3: Unsure
    22
        Week 2: Ques 3: Less
    13
        Week 3: Ques 3: No
    0
        Week 3: Ques 3: Unsure
    20
        Week 3: Ques 3: Less
    15
        Week 4: Ques 3: No
    0
        Week 4: Ques 3: Unsure
    21
        Week 4: Ques 3: Less
    14
        Week 8: Ques 3: No
    1
        Week 8: Ques 3: Unsure
    17
        Week 8: Ques 3: Less
    17
        Week 12: Ques 3: No
    0
        Week 12: Ques 3: Unsure
    18
        Week 12: Ques 3: Less
    17
        Week 16: Ques 3: No
    1
        Week 16: Ques 3: Unsure
    18
        Week 16: Ques 3: Less
    16
        Week 20: Ques 3: No
    1
        Week 20: Ques 3: Unsure
    18
        Week 20: Ques 3: Less
    16
        Week 24: Ques 3: No
    1
        Week 24: Ques 3: Unsure
    18
        Week 24: Ques 3: Less
    16
        Week 28: Ques 3: No
    2
        Week 28: Ques 3: Unsure
    17
        Week 28: Ques 3: Less
    16
        Week 32: Ques 3: No
    1
        Week 32: Ques 3: Unsure
    19
        Week 32: Ques 3: Less
    15
        Week 36: Ques 3: No
    1
        Week 36: Ques 3: Unsure
    20
        Week 36: Ques 3: Less
    14
        Week 40: Ques 3: No
    1
        Week 40: Ques 3: Unsure
    20
        Week 40: Ques 3: Less
    14
        Week 44: Ques 3: No
    1
        Week 44: Ques 3: Unsure
    19
        Week 44: Ques 3: Less
    15
        Endpoint (Week 48): Ques 3: No
    1
        Endpoint (Week 48): Ques 3: Unsure
    17
        Endpoint (Week 48): Ques 3: Less
    17
    Notes
    [39] - FAS population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to Week 52
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Risperidone
    Reporting group description
    		 Subjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (>=) received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8.

    Reporting group title
    Open Label Risperidone
    Reporting group description
    		 Subjects who completed the period 1 (either Risperidone Arm or Placebo Arm) and subjects who were eligible as per Investigator’s discretion continued to open label period 2. Subjects < 20 kg received risperidone 0.25 mg/day up to Day 4. On Day 4, dose was increased to 0.5 mg/day. Dose was titrated in increments of 0.25 mg/day at the regular study visit thereafter till Week 48. Subjects weighing >=20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was increased to 1.0 mg/day. Dose was titrated in increments of 0.5 mg/day at the regular study visit thereafter till Week 48. The maximum daily dose for subject weighing >=45 kg was 3.0 mg.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matching with risperidone from Day 1 up to Week 8.

    Serious adverse events
    		 Risperidone Open Label Risperidone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 35 (5.71%)
    1 / 18 (5.56%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Inguinal Hernia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 35 (2.86%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 35 (2.86%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Tracheobronchitis Mycoplasmal
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 35 (2.86%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 35 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Risperidone Open Label Risperidone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 21 (90.48%)
    34 / 35 (97.14%)
    16 / 18 (88.89%)
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 35 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 35 (2.86%)
    2 / 18 (11.11%)
         occurrences all number
    0
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 35 (8.57%)
    1 / 18 (5.56%)
         occurrences all number
    1
    6
    1
    Epistaxis
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 35 (5.71%)
    0 / 18 (0.00%)
         occurrences all number
    0
    3
    0
    Rhinitis Allergic
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 35 (5.71%)
    0 / 18 (0.00%)
         occurrences all number
    0
    3
    0
    Upper Respiratory Tract Inflammation
         subjects affected / exposed
    0 / 21 (0.00%)
    5 / 35 (14.29%)
    0 / 18 (0.00%)
         occurrences all number
    0
    6
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 35 (2.86%)
    0 / 18 (0.00%)
         occurrences all number
    2
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 35 (8.57%)
    1 / 18 (5.56%)
         occurrences all number
    0
    3
    2
    Sleep Disorder
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 35 (5.71%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    0
    Investigations
    Electrocardiogram QT Prolonged
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 35 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Weight Increased
         subjects affected / exposed
    4 / 21 (19.05%)
    12 / 35 (34.29%)
    0 / 18 (0.00%)
         occurrences all number
    4
    13
    0
    Injury, poisoning and procedural complications
    Arthropod Sting
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 35 (5.71%)
    0 / 18 (0.00%)
         occurrences all number
    1
    2
    0
    Joint Dislocation
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 35 (5.71%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    0
    Contusion
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 35 (5.71%)
    1 / 18 (5.56%)
         occurrences all number
    0
    3
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 35 (2.86%)
    0 / 18 (0.00%)
         occurrences all number
    2
    1
    0
    Drooling
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 35 (5.71%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    0
    Epilepsy
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 35 (5.71%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    0
    Headache
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 35 (8.57%)
    0 / 18 (0.00%)
         occurrences all number
    1
    3
    0
    Somnolence
         subjects affected / exposed
    11 / 21 (52.38%)
    17 / 35 (48.57%)
    2 / 18 (11.11%)
         occurrences all number
    13
    19
    2
    Eye disorders
    Conjunctivitis Allergic
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 35 (8.57%)
    0 / 18 (0.00%)
         occurrences all number
    1
    3
    0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 35 (5.71%)
    0 / 18 (0.00%)
         occurrences all number
    1
    3
    0
    Constipation
         subjects affected / exposed
    0 / 21 (0.00%)
    5 / 35 (14.29%)
    0 / 18 (0.00%)
         occurrences all number
    0
    5
    0
    Diarrhoea
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 35 (5.71%)
    2 / 18 (11.11%)
         occurrences all number
    2
    2
    3
    Dental Caries
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 35 (2.86%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Nausea
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 35 (2.86%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Vomiting
         subjects affected / exposed
    3 / 21 (14.29%)
    6 / 35 (17.14%)
    0 / 18 (0.00%)
         occurrences all number
    4
    9
    0
    Stomatitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 35 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Hepatobiliary disorders
    Hepatic Function Abnormal
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 35 (2.86%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 35 (5.71%)
    0 / 18 (0.00%)
         occurrences all number
    1
    3
    0
    Renal and urinary disorders
    Enuresis
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 35 (5.71%)
    2 / 18 (11.11%)
         occurrences all number
    1
    3
    2
    Endocrine disorders
    Hyperprolactinaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    4 / 35 (11.43%)
    0 / 18 (0.00%)
         occurrences all number
    0
    4
    0
    Infections and infestations
    Adenovirus Infection
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 35 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Bronchitis
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 35 (8.57%)
    1 / 18 (5.56%)
         occurrences all number
    0
    9
    2
    Conjunctivitis
         subjects affected / exposed
    0 / 21 (0.00%)
    4 / 35 (11.43%)
    0 / 18 (0.00%)
         occurrences all number
    0
    4
    0
    Cystitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 35 (2.86%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Influenza
         subjects affected / exposed
    1 / 21 (4.76%)
    7 / 35 (20.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    9
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 21 (4.76%)
    5 / 35 (14.29%)
    1 / 18 (5.56%)
         occurrences all number
    1
    6
    1
    Pharyngitis
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 35 (8.57%)
    1 / 18 (5.56%)
         occurrences all number
    1
    7
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 21 (9.52%)
    10 / 35 (28.57%)
    1 / 18 (5.56%)
         occurrences all number
    6
    18
    1
    Streptococcal Infection
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 35 (5.71%)
    1 / 18 (5.56%)
         occurrences all number
    0
    2
    1
    Tonsillitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 35 (2.86%)
    1 / 18 (5.56%)
         occurrences all number
    0
    2
    1
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 35 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Increased Appetite
         subjects affected / exposed
    5 / 21 (23.81%)
    10 / 35 (28.57%)
    0 / 18 (0.00%)
         occurrences all number
    6
    11
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 May 2012
    The original protocol dated 16 May 2012 was amended one time on 25 May 2012, for removal to avoid sampling bias, and addition to the safety analysis section to tabulate the suicide-related adverse events.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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