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    Clinical Trial Results:
    A 52-Week, Open-label, Multicenter Study of the Safety and Tolerability of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents with Autistic Disorder

    Summary
    EudraCT number
    2017-000175-86
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    05 Jun 2009

    Results information
    Results version number
    v1(current)
    This version publication date
    25 Feb 2018
    First version publication date
    25 Feb 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CN138-180
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00365859
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Otsuka America Pharmaceutical Inc
    Sponsor organisation address
    2440 Research Blvd, Rockville, MD 20850, United States,
    Public contact
    Angela Smith, Otsuka Pharmaceutical Development & Commercialization,, +1 860920-2209, angela.smith@otsuka-us.com
    Scientific contact
    Angela Smith, Otsuka Pharmaceutical Development & Commercialization,, +1 860920-2209, angela.smith@otsuka-us.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Nov 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jun 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jun 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial was to evaluate long-term safety and tolerability of aripiprazole flexibly dosed in the treatment of serious behavioral problems in children and adolescents with a diagnosis of autistic disorder.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki. The rights, safety, and well-being of the study patients were the most important consideration and prevailed over the interests of science and society.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Sep 2006
    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
    United States: 330
    Worldwide total number of subjects
    330
    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)
    244
    Adolescents (12-17 years)
    86
    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
    A total of 353 patients (109 de novo & 244 (placebo 70 + aripiprazole 174) rollover patients) were enrolled. Of 109 de novo patients, 23 had baseline failures & only 86 entered the treatment phase. Totally 330 patients ( 86 de novo + 70 placebo + 174 aripiprazole) entered the treatment (single oral dose of Aripiprazole [2 to 15 mg/day] tablet)

    Pre-assignment
    Screening details
    De novo patients had screening Phase of up to 42 days consisting of visit 1 (screening), visit 1a (washout period & interim screening) and visit 2 (baseline). Rollover patients had screening phase at visit 2 (screening & baseline, ). For rollover patients, screening and procedures were not repeated at visit 1 and 1a.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    This was an open label trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    De Novo
    Arm description
    Patients who did not participate in studies CN138178 or CN138179 were included, provided that they met the entry criteria specified in the protocol. Patients with history of serious behavioral problems with a diagnosis of autistic disorders and were currently treated orally with aripiprazole 2gm/day .
    Arm type
    Active comparator

    Investigational medicinal product name
    Aripiprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients were assigned to aripiprazole (tablet) once daily oral treatment, which was flexibly dosed (2 to 15 mg/day) on the basis of treatment response and medication tolerability. All patients received 2 mg/day aripiprazole on Day 1 of this open-label, long-term study.

    Arm title
    Placebo Rollover
    Arm description
    Rollover patients who were treated orally with placebo in CN138178 or CN138179 at a dose of 2 mg/day on Day 1 of the study.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    On Day 1 (the day after week 8 visit of the antecedent double-blind study), aripiprazole matching placebo was administered at 2 mg/day

    Arm title
    Aripiprazole Rollover
    Arm description
    Rollover patients who were treated orally with aripiprazole in CN138178 or CN138179 at a dose of 2 mg/day on Day 1 of the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Aripiprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients were assigned to aripiprazole (tablet) oral once daily treatment, which was flexibly dosed (2 to 15 mg/day) on the basis of treatment response and medication tolerability. Rollover patients received their first dose of study medication on Day 1 (the day after their Week 8 visit of the antecedent double-blind study). All rollover patients involved in the antecedent double-blind protocols (CN138178 or CN138179) had study medication re-titrated starting at 2 mg/day.

    Number of subjects in period 1
    De Novo Placebo Rollover Aripiprazole Rollover
    Started
    86
    70
    174
    Completed
    55
    37
    107
    Not completed
    31
    33
    67
         Administrative reason
    1
    1
    2
         Other
    1
    2
    4
         Patient no longer met study criteria
    1
    -
    1
         Lack of efficacy
    8
    5
    7
         Poor/noncompliance
    2
    1
    2
         Adverse event, non-fatal
    9
    11
    15
         Consent withdrawn by subject
    7
    5
    15
         Lost to follow-up
    2
    8
    21

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    De Novo
    Reporting group description
    Patients who did not participate in studies CN138178 or CN138179 were included, provided that they met the entry criteria specified in the protocol. Patients with history of serious behavioral problems with a diagnosis of autistic disorders and were currently treated orally with aripiprazole 2gm/day .

    Reporting group title
    Placebo Rollover
    Reporting group description
    Rollover patients who were treated orally with placebo in CN138178 or CN138179 at a dose of 2 mg/day on Day 1 of the study.

    Reporting group title
    Aripiprazole Rollover
    Reporting group description
    Rollover patients who were treated orally with aripiprazole in CN138178 or CN138179 at a dose of 2 mg/day on Day 1 of the study.

    Reporting group values
    De Novo Placebo Rollover Aripiprazole Rollover Total
    Number of subjects
    86 70 174 330
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    68 52 124 244
        Adolescents (12-17 years)
    18 18 50 86
        Adults (18-64 years)
    0 0 0 0
        From 65-84 years
    0 0 0 0
        85 years and over
    0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    9.7 ± 3.2 9.8 ± 3 9.7 ± 3 -
    Gender categorical
    Units: Subjects
        Female
    16 8 19 43
        Male
    70 62 155 287

    End points

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    End points reporting groups
    Reporting group title
    De Novo
    Reporting group description
    Patients who did not participate in studies CN138178 or CN138179 were included, provided that they met the entry criteria specified in the protocol. Patients with history of serious behavioral problems with a diagnosis of autistic disorders and were currently treated orally with aripiprazole 2gm/day .

    Reporting group title
    Placebo Rollover
    Reporting group description
    Rollover patients who were treated orally with placebo in CN138178 or CN138179 at a dose of 2 mg/day on Day 1 of the study.

    Reporting group title
    Aripiprazole Rollover
    Reporting group description
    Rollover patients who were treated orally with aripiprazole in CN138178 or CN138179 at a dose of 2 mg/day on Day 1 of the study.

    Primary: Safety and tolerability by assessment of the number of adverse events following oral teatment of Aripiprazole

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    End point title
    Safety and tolerability by assessment of the number of adverse events following oral teatment of Aripiprazole [1]
    End point description
    To assess the safety and tolerability of oral treatment of Aripiprazole. Safety outcome measures included the incidence of death, serious adverse events (SAEs), treatment-emergent AEs and AEs leading to discontinuation. An AE is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. Safety and tolerability were assessed by vital sign measurements; body weight/BMI; ECGs; clinical laboratory evaluations; physical examinations; adverse events; and treatment discontinuations.
    End point type
    Primary
    End point timeframe
    Adverse events (AEs) were collected from the screening visit to week 52
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics were presented. Frequencies and percentages are presented for categorical data. No formal statistical tests were planned.
    End point values
    De Novo Placebo Rollover Aripiprazole Rollover
    Number of subjects analysed
    85
    70
    171
    Units: Numbers
        All Treatment-Emergent Adverse Events (TEAEs)
    75
    63
    148
        Treatment-Emergent Serious AEs
    3
    1
    5
        Serious Related TEAEs
    0
    1
    0
        TEAEs led to discontinuation
    9
    10
    14
    No statistical analyses for this end point

    Primary: Extrapyramidal symptoms (EPS)-related adverse events

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    End point title
    Extrapyramidal symptoms (EPS)-related adverse events [2]
    End point description
    To assess the safety and tolerability of oral treatment of Aripiprazole by evaluating extrapyramidal symptoms (EPS) related AEs (including the change from baseline in the Simpson-Angus Rating Scale or Statistical Analysis Software (SAS) score, the abnormal involuntary movement scale (AIMS) score, and the Barnes Akathisia Scale).
    End point type
    Primary
    End point timeframe
    At week 0, week 8, week 26 and week 52
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics are presented. Frequencies and percentages are presented for categorical data. No formal statistical tests were planned.
    End point values
    De Novo Placebo Rollover Aripiprazole Rollover
    Number of subjects analysed
    86
    70
    174
    Units: Number of participants
        Any EPS-Related Adverse Event (overall count)
    16
    6
    26
        Parkinsonism Events (Total count)
    5
    4
    10
        Tremor
    4
    3
    3
        Extrapyramidal Disorder
    1
    0
    4
        Cogwheel Rigidity
    1
    0
    2
        Asterixis
    0
    0
    1
        Masked Facies
    0
    1
    0
        Akathisia Events (Total count)
    3
    1
    12
        Psychomotor Hyperactivity
    1
    0
    8
        Akathisia
    3
    1
    4
        Dyskinetic Events (Total count)
    6
    0
    3
        Dyskinesia
    5
    0
    3
        Choreoathetosis
    1
    0
    0
        Dystonic Events (Total count)
    0
    1
    1
        Muscle Rigidity
    0
    1
    0
        Muscle Spasms
    0
    0
    1
        Residual Events (Total count)
    2
    0
    0
        Muscle Twitching
    2
    0
    0
    No statistical analyses for this end point

    Secondary: Aberrant Behavior Checklist (ABC) Subscale Score

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    End point title
    Aberrant Behavior Checklist (ABC) Subscale Score
    End point description
    To evaluate the mean change from baseline in each of the 5 ABC (Aberrant Behavior Checklist) subscale score. ABC subscale score was used to assess and classify problem behaviors of children and adolescents with mental retardation. It is a 4-point scale with scores ranging from 0 (not al all a problem) to 3 (the problem is severe in degree) with 5 subscales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactivity, and Inappropriate Speech). A negative change score signified improvement.
    End point type
    Secondary
    End point timeframe
    At screening, week 0, week 4, week 8 and once every 6 weeks until week 52
    End point values
    De Novo Placebo Rollover Aripiprazole Rollover
    Number of subjects analysed
    84
    69
    169
    Units: Mean
    arithmetic mean (standard deviation)
        ABC Irritability Subscale Score ( 0 to 45)
    -6.5 ± 11.12
    -6.1 ± 11.25
    0.7 ± 9.72
        ABC Hyperactivity Subscale Score (0 to 48)
    -10 ± 10.55
    -8.3 ± 10.85
    0.3 ± 11.18
        ABC Stereotypy Subscale Score (0 to 21)
    -2.5 ± 4.67
    -1.9 ± 4.46
    0.1 ± 4.58
        ABC Social Withdrawal Subscale Score (0 to 48)
    -5.4 ± 9.07
    -3 ± 6.96
    -1.8 ± 6.09
        ABC Inappropriate Speech Subscale Score (0 to 12)
    -1.9 ± 2.66
    -1.8 ± 2.94
    -0.3 ± 2.5
    No statistical analyses for this end point

    Secondary: Clinical Global Impression (CGI) score

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    End point title
    Clinical Global Impression (CGI) score
    End point description
    The CGI rating scale was used to evaluate participant's improvement over time. A baseline, CGI-s assessment was performed to rate the severity of the participant's condition on a 7-point scale ranging from 1 (no symptoms) to 7 ( very severe symptoms). At subsequent visits, the participant’s improvement relative to the symptoms at baseline was assessed on a 7-point CGI-Improvement (CGI-I) scale ranging from 1 (very much improved) to 7 (very much worse). Since, the target symptoms for the medication was specifically for irritability, the CGI focused specifically on severity of irritability secondary to autistic disorder.
    End point type
    Secondary
    End point timeframe
    At screening and from week 0 to week 52 (for severity); from week 1 to week 52 (for improvement)
    End point values
    De Novo Placebo Rollover Aripiprazole Rollover
    Number of subjects analysed
    84
    69
    169
    Units: Mean
    arithmetic mean (standard deviation)
        CGI-Severity (CGI-S) Score
    -0.8 ± 0.85
    -0.4 ± 1.06
    0 ± 1.01
        CGI-Improvement (CGI-I) Score
    2.7 ± 1.3
    2.4 ± 1.24
    2.5 ± 1.2
    No statistical analyses for this end point

    Secondary: Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

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    End point title
    Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
    End point description
    The CY-BOCS, a 10-item clinician-rated scale designed to measure the severity of obsessive-compulsive symptoms in participants below the age of 18. The CY-BOCS contains 5 items pertaining to obsessions (which were not used in this trial) and 5 items pertaining to compulsions, which rated each symptom domain in terms of time spent, interference with functioning, distress, resistance, and control. Each item was rated on a 5-point scale, from 0 (no symptoms or minimum severity) to 4 (extreme symptoms or maximum severity). A negative change score signifies improvement. Administration was modified for the purposes of this trial to allow for assessment based on an interview with the participant’s parent or guardian. In this study, only compulsions were assessed due to communication difficulties in this patient population.
    End point type
    Secondary
    End point timeframe
    At week 0 and week 52
    End point values
    De Novo Placebo Rollover Aripiprazole Rollover
    Number of subjects analysed
    62
    49
    115
    Units: Mean
    arithmetic mean (standard deviation)
        CGI-Improvement Score
    -2 ± 3.68
    -2.4 ± 5.06
    0.2 ± 3.81
    No statistical analyses for this end point

    Secondary: Mean change from baseline in the Pediatric Quality of Life Questionnaire (PedsQL)

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    End point title
    Mean change from baseline in the Pediatric Quality of Life Questionnaire (PedsQL)
    End point description
    The PedsQL is a health-related quality-of-life instrument developed and validated for use with children and adolescents. The primary analysis was the combined scales total across the age groups (child age 5 - 7, child age 8 - 12, and teen age 13 - 18), with a secondary analysis for separate age groups (child age 5 - 7, child 8 - 12 and teen age 13 - 18) and each separate scale (emotional functioning (5 items), social functioning (5 items) and cognitive functioning (6 items) were the scales used in PedsQL. The instructions asked the parent how much of a problem each item had occurred during the past 1 month. A 5-point response scale was used to rate each item (0 = never a problem, 4 = almost always a problem). Items were reverse-scored and linearly transformed to a 0 to 100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0), so that higher scores indicated better health-related quality of life.
    End point type
    Secondary
    End point timeframe
    At week 0 and week 52
    End point values
    De Novo Placebo Rollover Aripiprazole Rollover
    Number of subjects analysed
    84
    69
    169
    Units: Response
    arithmetic mean (standard deviation)
        Combined Scales (Participant count = 65, 48 & 117
    12.2 ± 16.14
    2.9 ± 16.42
    1 ± 15.9
        Emotional (Participant count = 65, 48 & 118)
    12.7 ± 21.29
    4.9 ± 20.47
    -1.2 ± 19.28
        Social (Participant count = 65, 48 & 117)
    7.6 ± 23.83
    3.6 ± 25.92
    2.1 ± 22.49
        Cognitive Function (Participant count=65,48 & 116)
    16 ± 19.6
    0.6 ± 24.99
    1.6 ± 21.19
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From week 1 to week 52
    Adverse event reporting additional description
    For serious adverse events - From screening to week 52. Four patients entered treatment phase, but were not treated. hence, they were not included in the safety (AEs) analysis. One patient in de novo arm was discontinued from the study due to severe suicidal ideation. Thereby, only 85 subjects were included in the safety analysis.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12
    Reporting groups
    Reporting group title
    De Novo
    Reporting group description
    Patients who did not participate in protocols CN138178 or CN138179. Patients with history of serious behavioral problems with a diagnosis of autistic disorders and were currently treated orally with aripiprazole 2gm/day . One participant was not dosed and thus was not included in the safety analysis analysis.

    Reporting group title
    Placebo Rollover
    Reporting group description
    Rollover patients who were treated orally with placebo in CN138178 or CN138179 at a dose of 2 mg/day on Day 1 of the study.

    Reporting group title
    Aripiprazole Rollover
    Reporting group description
    Rollover patients who were treated orally with aripiprazole in CN138178 or CN138179 at a dose of 2 mg/day on Day 1 of the study. Three participants did not receive medication and were not included in the safety analysis.

    Serious adverse events
    De Novo Placebo Rollover Aripiprazole Rollover
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 85 (3.53%)
    1 / 70 (1.43%)
    5 / 171 (2.92%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 70 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 70 (1.43%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 70 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 70 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impulsive Behaviour
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 70 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 70 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 70 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 70 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Otitis Media Acute
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 70 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 70 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 70 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin Infection
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 70 (0.00%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         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
    De Novo Placebo Rollover Aripiprazole Rollover
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    75 / 85 (88.24%)
    63 / 70 (90.00%)
    148 / 171 (86.55%)
    Investigations
    Weight Increased
         subjects affected / exposed
    20 / 85 (23.53%)
    16 / 70 (22.86%)
    40 / 171 (23.39%)
         occurrences all number
    30
    20
    75
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 85 (11.76%)
    6 / 70 (8.57%)
    15 / 171 (8.77%)
         occurrences all number
    15
    7
    27
    Epistaxis
         subjects affected / exposed
    8 / 85 (9.41%)
    3 / 70 (4.29%)
    10 / 171 (5.85%)
         occurrences all number
    22
    12
    24
    Nasal Congestion
         subjects affected / exposed
    10 / 85 (11.76%)
    0 / 70 (0.00%)
    11 / 171 (6.43%)
         occurrences all number
    17
    0
    14
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 85 (8.24%)
    7 / 70 (10.00%)
    18 / 171 (10.53%)
         occurrences all number
    13
    11
    32
    Sedation
         subjects affected / exposed
    8 / 85 (9.41%)
    10 / 70 (14.29%)
    9 / 171 (5.26%)
         occurrences all number
    16
    17
    12
    Drooling
         subjects affected / exposed
    3 / 85 (3.53%)
    3 / 70 (4.29%)
    15 / 171 (8.77%)
         occurrences all number
    5
    5
    23
    Somnolence
         subjects affected / exposed
    4 / 85 (4.71%)
    6 / 70 (8.57%)
    3 / 171 (1.75%)
         occurrences all number
    8
    12
    11
    Lethargy
         subjects affected / exposed
    7 / 85 (8.24%)
    1 / 70 (1.43%)
    2 / 171 (1.17%)
         occurrences all number
    10
    1
    2
    Dyskinesia
         subjects affected / exposed
    5 / 85 (5.88%)
    0 / 70 (0.00%)
    3 / 171 (1.75%)
         occurrences all number
    8
    0
    5
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    6 / 85 (7.06%)
    10 / 70 (14.29%)
    23 / 171 (13.45%)
         occurrences all number
    7
    12
    24
    Fatigue
         subjects affected / exposed
    7 / 85 (8.24%)
    7 / 70 (10.00%)
    9 / 171 (5.26%)
         occurrences all number
    15
    14
    13
    Irritability
         subjects affected / exposed
    4 / 85 (4.71%)
    1 / 70 (1.43%)
    11 / 171 (6.43%)
         occurrences all number
    12
    3
    28
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    17 / 85 (20.00%)
    12 / 70 (17.14%)
    34 / 171 (19.88%)
         occurrences all number
    19
    24
    65
    Diarrhoea
         subjects affected / exposed
    7 / 85 (8.24%)
    8 / 70 (11.43%)
    15 / 171 (8.77%)
         occurrences all number
    9
    10
    21
    Constipation
         subjects affected / exposed
    6 / 85 (7.06%)
    4 / 70 (5.71%)
    7 / 171 (4.09%)
         occurrences all number
    10
    5
    8
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    7 / 85 (8.24%)
    8 / 70 (11.43%)
    18 / 171 (10.53%)
         occurrences all number
    19
    12
    24
    Aggression
         subjects affected / exposed
    8 / 85 (9.41%)
    6 / 70 (8.57%)
    15 / 171 (8.77%)
         occurrences all number
    12
    8
    26
    Agitation
         subjects affected / exposed
    7 / 85 (8.24%)
    2 / 70 (2.86%)
    11 / 171 (6.43%)
         occurrences all number
    9
    3
    12
    Anxiety
         subjects affected / exposed
    3 / 85 (3.53%)
    0 / 70 (0.00%)
    9 / 171 (5.26%)
         occurrences all number
    6
    0
    13
    Tic
         subjects affected / exposed
    1 / 85 (1.18%)
    6 / 70 (8.57%)
    2 / 171 (1.17%)
         occurrences all number
    2
    8
    4
    Stereotypy
         subjects affected / exposed
    4 / 85 (4.71%)
    1 / 70 (1.43%)
    9 / 171 (5.26%)
         occurrences all number
    4
    2
    15
    Renal and urinary disorders
    Enuresis
         subjects affected / exposed
    5 / 85 (5.88%)
    4 / 70 (5.71%)
    6 / 171 (3.51%)
         occurrences all number
    10
    6
    17
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    5 / 85 (5.88%)
    3 / 70 (4.29%)
    7 / 171 (4.09%)
         occurrences all number
    7
    6
    8
    Metabolism and nutrition disorders
    Increased Appetite
         subjects affected / exposed
    16 / 85 (18.82%)
    8 / 70 (11.43%)
    19 / 171 (11.11%)
         occurrences all number
    20
    18
    35
    Decreased Appetite
         subjects affected / exposed
    6 / 85 (7.06%)
    2 / 70 (2.86%)
    7 / 171 (4.09%)
         occurrences all number
    9
    3
    15
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 85 (15.29%)
    10 / 70 (14.29%)
    21 / 171 (12.28%)
         occurrences all number
    21
    17
    34
    Upper Respiratory Tract Infection
         subjects affected / exposed
    11 / 85 (12.94%)
    12 / 70 (17.14%)
    16 / 171 (9.36%)
         occurrences all number
    29
    27
    23
    Ear Infection
         subjects affected / exposed
    3 / 85 (3.53%)
    2 / 70 (2.86%)
    15 / 171 (8.77%)
         occurrences all number
    5
    2
    21
    Sinusitis
         subjects affected / exposed
    8 / 85 (9.41%)
    2 / 70 (2.86%)
    10 / 171 (5.85%)
         occurrences all number
    14
    2
    17
    Gastroenteritis Viral
         subjects affected / exposed
    5 / 85 (5.88%)
    1 / 70 (1.43%)
    8 / 171 (4.68%)
         occurrences all number
    7
    2
    9

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Dec 2006
    Amendment 01: • Decrease of washout period • Removal of separate rater requirement • Increase of sample size • Addition of inclusion of de novo patients • Changes to PedsQL • Addition of CGSQ • Clarify requirements for mental age assessment • Withdrawl of CGI as safety objective • Administrative and typographical changes
    17 Jun 2007
    Amendment 02: • Clarification regarding de novo patients' entrance criteria • Decrease number of days that efficacy evaluations will be included for analysis • Mental age requirement specifications • Collection of insulin collection and evaluation • Window visits defined • Allowance of use of historical ADI-R • Extension of enrollment period • DSMB to receive efficacy data for review only • Addition of mental age assessment at baseline if not done at screening • Administrative and typographical changes

    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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