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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-weekly Oral Aripiprazole in Children and Adolescents with Tourette’s Disorder

    Summary
    EudraCT number
    		 2011-000468-83
    Trial protocol
    		 DE   BG  
    Global end of trial date
    12 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Mar 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    31-10-273
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Otsuka Pharmaceutical Development & Commercialization, Inc.
    Sponsor organisation address
    2440 Research Boulevard, Rockville, Maryland, United States, 20850
    Public contact
    Eva Kohegyi, MD, Otsuka Pharmaceutical Development & Commercialization, Inc., +1 609 524 6790, Eva.Kohegyi@otsuka-us.com
    Scientific contact
    Eva Kohegyi, MD, Otsuka Pharmaceutical Development & Commercialization, Inc., +1 609 524 6790, Eva.Kohegyi@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
    08 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Mar 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Primary objective was to compare the efficacy of aripiprazole with placebo in the suppression of tics in children and adolescents (7-17 years) with a diagnosis of Tourette’s Disorder. The primary efficacy measure is change from Baseline to endpoint (Week 8) on the Total Tic score (TTS) of the Yale Global Tic Severity Scale (YGTSS). Secondary efficacy measures included Clinical Global Impressions Scale for Tourette’s Syndrome (CGI-TS) and Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL). The secondary objective was to evaluate the safety and tolerability of aripiprazole once-weekly treatment with oral tablets in children and adolescents with Tourette's Disorder.
    Protection of trial subjects
    This trial was conducted in compliance with the protocol, International Conference on Harmonisation Good Clinical Practice (ICH GCP), and applicable local laws and regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Aug 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Romania: 15
    Country: Number of subjects enrolled
    Ukraine: 27
    Country: Number of subjects enrolled
    United States: 30
    Country: Number of subjects enrolled
    Bulgaria: 5
    Country: Number of subjects enrolled
    Germany: 6
    Worldwide total number of subjects
    83
    EEA total number of subjects
    26
    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)
    39
    Adolescents (12-17 years)
    44
    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
    		 This trial was conducted in 83 participants at 38 trial sites in the following 5 countries: Bulgaria, Germany, Romania, Ukraine, and the United States.

    Pre-assignment
    Screening details
    		 This trial consisted of 2 distinct phases: a pre-treatment phase and a treatment phase. The pre-treatment phase consisted of a screening period, a washout period, and a Baseline visit. This was followed by an 8-week treatment phase. There was a follow-up period (30 ± 3 days) for those participants who did not roll-over into the open-label trial.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The blind was not broken for any participants before database lock.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Aripiprazole 52.5 mg
    Arm description
    		 Participants were administered aripiprazole orally with a dose of 52.5 milligram (mg) weekly for the 8-week treatment phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aripiprazole enteric-coated extended-release (ECER) Tablets 52.5 mg
    Investigational medicinal product code
    Other name
    Aripiprazole, OPC-14597
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were administered a dosage of 52.5 mg aripiprazole tablets orally weekly

    Arm title
    		 Aripiprazole 77.5 mg
    Arm description
    		 Participants were administered 77.5 mg of aripiprazole oral tablets weekly for the 8-week treatment phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aripiprazole ECER Tablets 77.5 mg
    Investigational medicinal product code
    Other name
    Aripiprazole, OPC-14597
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were administered a dosage of 77.5 mg aripiprazole tablets orally weekly

    Arm title
    		 Aripiprazole 110 mg
    Arm description
    		 Participants were administered 110 mg of aripiprazole oral tablets weekly for the 8-week treatment phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aripiprazole ECER Tablets 110 mg
    Investigational medicinal product code
    Other name
    Aripiprazole, OPC-14597
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were administered a dosage of 110 mg aripiprazole tablets orally weekly

    Arm title
    		 Placebo
    Arm description
    		 Participants were administered matching placebo tablets weekly
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were administered matching placebo tablets in the same way as aripiprazole

    Number of subjects in period 1
    		Aripiprazole 52.5 mg Aripiprazole 77.5 mg Aripiprazole 110 mg Placebo
    Started
    20
    21
    21
    21
    Completed
    17
    17
    16
    18
    Not completed
    3
    4
    5
    3
         Consent withdrawn by subject
    -
    1
    2
    1
         Adverse Event
    -
    1
    -
    -
         Lost to follow-up
    2
    -
    -
    -
         Sponsor Discontinued Trial
    -
    2
    2
    2
         Lack of efficacy
    1
    -
    -
    -
         Protocol deviation
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Aripiprazole 52.5 mg
    Reporting group description
    		 Participants were administered aripiprazole orally with a dose of 52.5 milligram (mg) weekly for the 8-week treatment phase.

    Reporting group title
    Aripiprazole 77.5 mg
    Reporting group description
    		 Participants were administered 77.5 mg of aripiprazole oral tablets weekly for the 8-week treatment phase.

    Reporting group title
    Aripiprazole 110 mg
    Reporting group description
    		 Participants were administered 110 mg of aripiprazole oral tablets weekly for the 8-week treatment phase.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were administered matching placebo tablets weekly

    Reporting group values
    		 Aripiprazole 52.5 mg Aripiprazole 77.5 mg Aripiprazole 110 mg Placebo Total
    Number of subjects
    		 20 21 21 21 83
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 11.5 ( 3.4 ) 11.7 ( 2.8 ) 12.5 ( 2.7 ) 11.8 ( 2.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 8 3 6 20
        Male
    		 17 13 18 15 63

    End points

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    End points reporting groups
    Reporting group title
    Aripiprazole 52.5 mg
    Reporting group description
    		 Participants were administered aripiprazole orally with a dose of 52.5 milligram (mg) weekly for the 8-week treatment phase.

    Reporting group title
    Aripiprazole 77.5 mg
    Reporting group description
    		 Participants were administered 77.5 mg of aripiprazole oral tablets weekly for the 8-week treatment phase.

    Reporting group title
    Aripiprazole 110 mg
    Reporting group description
    		 Participants were administered 110 mg of aripiprazole oral tablets weekly for the 8-week treatment phase.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were administered matching placebo tablets weekly

    Primary: Mean change from Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) total tic score

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    End point title
    		 Mean change from Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) total tic score [1]
    End point description
    The YGTSS is a semi-structured clinical interview designed to measure current tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics, each including number, frequency, intensity, complexity, and interference. The total tic score (TTS) ranged from 0 (none) to 50 (severe) with higher score for more severe symptoms (greater reduction from baseline for greater improvement). The YGTSS ranking of impairment, with a maximum of 50 points, is based on the impact of the tic disorder on areas of self esteem, family life, social acceptance and school scores. This is a fully validated scale in adults and has become a standard instrument for the evaluation of the severity of Tourette’s Disorder in children. In an Intent-to-Treat (ITT) population, participants were randomly assigned to the double-blind treatment.
    End point type
    Primary
    End point timeframe
    Baseline to Week 8
    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: No statistical analyses were defined for this endpoint because the trial was discontinued by the sponsor with a much smaller sample size than originally planned.
    End point values
    		 Aripiprazole 52.5 mg Aripiprazole 77.5 mg Aripiprazole 110 mg Placebo
    Number of subjects analysed
    17
    17
    16
    18
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -8.2 ( 4.8 )
    -9.9 ( 6.7 )
    -14.5 ( 7.7 )
    -9.6 ( 7.5 )
    No statistical analyses for this end point

    Secondary: Clinical Global Impressions Scale for Tourette’s Syndrome (CGI-TS) change score at Week 8

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    End point title
    		 Clinical Global Impressions Scale for Tourette’s Syndrome (CGI-TS) change score at Week 8
    End point description
    The severity of illness and efficacy of study medication for each participant were rated using the CGI-TS scale. The study physician were to rate the participants total improvement whether or not it is due to study treatment. All responses were compared to the participants condition at Baseline (Day 0). Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Aripiprazole 52.5 mg Aripiprazole 77.5 mg Aripiprazole 110 mg Placebo
    Number of subjects analysed
    17
    16
    16
    18
    Units: Units on a scale
        arithmetic mean (standard deviation)
    2.7 ( 1 )
    2.8 ( 0.8 )
    2.3 ( 1.1 )
    2.6 ( 0.9 )
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) at Week 8

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    End point title
    		 Mean change from Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) at Week 8
    End point description
    The GTS-QOL is a disease-specific patient-reported scale for the measurement of health-related quality of life in participants with Tourette’s Disorder, taking into account the complexity of the clinical picture of the disease. The questionnaire consists of a 27-item Tourette’s Disorder-specific scale with 4 subscales (psychological, physical, obsessional, and cognitive). The GTS-QOL total score ranged from 0 (extremely dissatisfied with life) and 100 (extremely satisfied with life).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    End point values
    		 Aripiprazole 52.5 mg Aripiprazole 77.5 mg Aripiprazole 110 mg Placebo
    Number of subjects analysed
    17
    17
    16
    18
    Units: Units on a scale
        arithmetic mean (standard deviation)
    8.8 ( 14.1 )
    3.8 ( 24.4 )
    13.1 ( 20.9 )
    13.4 ( 15.9 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the signing of the informed consent until the follow-up visit 30 (± 3) days.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Aripiprazole 52.5 mg
    Reporting group description
    		 Participants were administered aripiprazole orally with a dose of 52.5 mg weekly for the 8-week treatment phase.

    Reporting group title
    Aripiprazole 77.5 mg
    Reporting group description
    		 Participants were administered 77.5 mg of aripiprazole oral tablets weekly for the 8-week treatment phase.

    Reporting group title
    Aripiprazole 110 mg
    Reporting group description
    		 Participants were administered 110 mg of aripiprazole oral tablets weekly for the 8-week treatment phase.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were administered matching placebo tablets weekly

    Serious adverse events
    		 Aripiprazole 52.5 mg Aripiprazole 77.5 mg Aripiprazole 110 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Aripiprazole 52.5 mg Aripiprazole 77.5 mg Aripiprazole 110 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 20 (40.00%)
    8 / 21 (38.10%)
    17 / 21 (80.95%)
    7 / 21 (33.33%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    4 / 21 (19.05%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    5
    1
    Influenza like illness
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hiccups
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    1 / 21 (4.76%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    1
    Pharyngeal erythema
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Anxiety
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Apathy
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hallucination, auditory
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Restlessness
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Blood prolactin decreased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Weight increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Hand fracture
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    1
    Wound
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Palpitations
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tachycardia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    1
    Disturbance in attention
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Dizziness
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    2 / 21 (9.52%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Headache
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 21 (9.52%)
    8 / 21 (38.10%)
    2 / 21 (9.52%)
         occurrences all number
    2
    3
    10
    2
    Hypotonia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sedation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    0
    1
    Slow response to stimuli
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Somnolence
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 21 (14.29%)
    6 / 21 (28.57%)
    0 / 21 (0.00%)
         occurrences all number
    1
    11
    9
    0
    Tremor
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye disorders
    Ocular hyperaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    2 / 21 (9.52%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Diarrhoea
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    2 / 21 (9.52%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Lip dry
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    3 / 21 (14.29%)
    1 / 21 (4.76%)
         occurrences all number
    2
    0
    3
    1
    Vomiting
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    2 / 21 (9.52%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    3
    0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Back pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pain in jaw
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    2 / 21 (9.52%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    2
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    2 / 21 (9.52%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Increased appetite
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Feb 2013
    In protocol amendment 1, substantial revisions were made such as; To remove the option of allowing subjects to roll over into Study 31-10-274 if they terminated early due to lack of efficacy at Week 5 or later in the previous trial; To clarify the criteria for the exclusion of subjects based on QTc values; To increase the expected duration of the entire trial;To update the statistical methods; To clarify the process of breaking the blind; To update the sample handling for blood for metabolic profiling; To update the protocol with new OPDC standard sections on reporting of product quality complaints.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    03 Sep 2013
    The trial was terminated early based on the review of the recent data from placebo-controlled Trial 31-10-272 (aripiprazole QW) relative to the results of the placebo-controlled Trial 31-12-293 (aripiprazole once daily [QD]) in subjects with TD. The aripiprazole QW formulation was found to be statistically superior to placebo in Trial 31-10-272, but the demonstrated efficacy was not as robust as that observed with the QD formulation. Therefore, OPDC discontinued trial 31-10-273 because the aripiprazole QW formulation will not be pursued for the treatment of TD. Importantly, the trial closure was unrelated to any safety issues (no signals or items of concern have been identified).
    -

    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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