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    Clinical Trial Results:
    Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-reference, Flexible-dose Study of Brexpiprazole in Patients With Acute Schizophrenia

    Summary
    EudraCT number
    		 2012-002252-17
    Trial protocol
    		 CZ   DE   EE   SK   PL   RO  
    Global end of trial date
    17 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jul 2016
    First version publication date
    14 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    14644A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01810380
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark, 2500
    Public contact
    Email contact via, H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com
    Scientific contact
    Email contact via, H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.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
    17 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2008) and ICH Good Clinical Practice (1996)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Mar 2013
    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
    Estonia: 11
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    Romania: 38
    Country: Number of subjects enrolled
    Russian Federation: 116
    Country: Number of subjects enrolled
    Serbia: 35
    Country: Number of subjects enrolled
    Slovakia: 3
    Country: Number of subjects enrolled
    Ukraine: 88
    Country: Number of subjects enrolled
    United States: 160
    Worldwide total number of subjects
    468
    EEA total number of subjects
    69
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    466
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who met each of the inclusion and none of the exclusion criteria were eligible to participate in the study

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    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
    Once daily as tablets and capsules, orally

    Arm title
    		 Brexpiprazole
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brexpiprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

    Arm title
    		 Quetiapine extended release
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Quetiapine Extended Release
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

    Number of subjects in period 1
    		Placebo Brexpiprazole Quetiapine extended release
    Started
    163
    151
    154
    Treated
    161
    150
    153
    Completed
    108
    113
    122
    Not completed
    55
    38
    32
         Consent withdrawn by subject
    6
    -
    6
         Randomised not treated
    2
    1
    1
         Administrative or other reasons
    11
    13
    9
         Adverse event, non-fatal
    11
    14
    4
         Lack of efficacy
    24
    10
    11
         Protocol deviation
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Brexpiprazole
    Reporting group description
    		 -

    Reporting group title
    Quetiapine extended release
    Reporting group description
    		 -

    Reporting group values
    		 Placebo Brexpiprazole Quetiapine extended release Total
    Number of subjects
    		 163 151 154 468
    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)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 163 150 153 466
        From 65-84 years
    		 0 1 1 2
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.59 ( 10.75 ) 39.81 ( 10.96 ) 41.07 ( 10.89 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 70 67 64 201
        Male
    		 93 84 90 267
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 0 1
        Asian
    		 2 1 0 3
        Native Hawaiian or Other Pacific Islander
    		 1 0 1 2
        Black or African American
    		 37 33 38 108
        White
    		 123 114 114 351
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 2 1 3

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Brexpiprazole
    Reporting group description
    		 -

    Reporting group title
    Quetiapine extended release
    Reporting group description
    		 -

    Primary: Change from baseline to Week 6 in PANSS total score

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    End point title
    		 Change from baseline to Week 6 in PANSS total score
    End point description
    The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Population Description: Full Analysis Set (FAS)
    End point type
    Primary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    159
    150
    150
    Units: units on a scale
        arithmetic mean (standard error)
    -15.9 ( 1.5 )
    -20 ( 1.5 )
    -24 ( 1.5 )
    Statistical analysis title
    		 Placebo vs. Brexpiprazole
    Statistical analysis description
    The overall significance level was 0.05. The primary and the key secondary endpoints were tested hierarchically. Only if the primary endpoint was statistically significant would confirmatory testing continue with the key secondary endpoint.
    Comparison groups
    Placebo v Brexpiprazole
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.056 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Least square mean difference
    Point estimate
    -4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.2
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.1
    Notes
    [1] - For all efficacy analyses the primary comparison is the difference between brexpiprazole 2 to 4 mg/day and placebo at Week 6.
    Statistical analysis title
    		 Placebo vs. Quetiapine Extended Release
    Comparison groups
    Placebo v Quetiapine extended release
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0002
    Method
    		 Mixed models analysis
    Parameter type
    		 Least square mean difference
    Point estimate
    -8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.2
         upper limit
    		 -3.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.1

    Secondary: Change from baseline to Week 6 in CGI-S score

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    End point title
    		 Change from baseline to Week 6 in CGI-S score
    End point description
    The Clinical Global Impression – Severity of Illness (CGI-S) provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Population Description: FAS
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    159
    150
    150
    Units: units on a scale
        arithmetic mean (standard error)
    -0.9 ( 0.1 )
    -1.2 ( 0.1 )
    -1.4 ( 0.1 )
    No statistical analyses for this end point

    Secondary: CGI-I score at Week 6

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    End point title
    		 CGI-I score at Week 6
    End point description
    The Clinical Global Impression – Global Improvement (CGI-I) provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. Population Description: FAS
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    159
    150
    150
    Units: units on a scale
        arithmetic mean (standard error)
    3 ( 0.1 )
    2.7 ( 0.1 )
    2.5 ( 0.1 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 6 in PANSS Positive Subscale score

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    End point title
    		 Change from baseline to Week 6 in PANSS Positive Subscale score
    End point description
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Positive Subscale score is calculated from 7 items (for example: delusions, conceptual disorganization and hallucinatory behaviour). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms Population Description: FAS
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    159
    150
    150
    Units: units on a scale
        arithmetic mean (standard error)
    -5.4 ( 0.5 )
    -7 ( 0.5 )
    -8.1 ( 0.5 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 6 in PANSS Negative Subscale score

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    End point title
    		 Change from baseline to Week 6 in PANSS Negative Subscale score
    End point description
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Negative Subscale score is calculated from 7 items (for example: blunted affect, emotional withdrawal and poor rapport). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms Population Description: FAS
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    159
    150
    150
    Units: units on a scale
        arithmetic mean (standard error)
    -3.1 ( 0.4 )
    -3.7 ( 0.4 )
    -4.5 ( 0.4 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 6 in PANSS General Psychopathology Subscale score

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    End point title
    		 Change from baseline to Week 6 in PANSS General Psychopathology Subscale score
    End point description
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS General Psychopathology Subscale score is calculated from 16 items (for example: somatic concern, anxiety and guilt feelings). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms Population Description: FAS
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    159
    150
    150
    Units: units on a scale
        arithmetic mean (standard error)
    -8.2 ( 0.7 )
    -9.9 ( 0.7 )
    -11.6 ( 0.7 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 6 in PANSS Excited Component score

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    End point title
    		 Change from baseline to Week 6 in PANSS Excited Component score
    End point description
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Excited Component score is calculated from 5 items (for example: poor impulse control, tension and hostility). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms Population Description: FAS
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    159
    150
    150
    Units: units on a scale
        arithmetic mean (standard error)
    -2.5 ( 0.3 )
    -3.3 ( 0.3 )
    -3.9 ( 0.3 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 6 in PANSS Marder Factor scores: negative symptoms

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    End point title
    		 Change from baseline to Week 6 in PANSS Marder Factor scores: negative symptoms
    End point description
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: negative symptoms is calculated from 7 items (for example: blunted affect, emotional withdrawal and motor retardation). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms Population Description: FAS
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    159
    150
    150
    Units: units on a scale
        arithmetic mean (standard error)
    -3.6 ( 0.4 )
    -4.3 ( 0.4 )
    -4.8 ( 0.4 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 6 in PANSS Marder Factor scores: positive symptoms

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    End point title
    		 Change from baseline to Week 6 in PANSS Marder Factor scores: positive symptoms
    End point description
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: positive symptoms is calculated from 8 items (for example: delusions, conceptual disorganization and stereotype thinking). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms Population Description: FAS
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    159
    150
    150
    Units: units on a scale
        arithmetic mean (standard error)
    -5.7 ( 0.5 )
    -7.1 ( 0.5 )
    -8.4 ( 0.5 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 6 in PANSS Marder Factor scores: disorganized thoughts

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    End point title
    		 Change from baseline to Week 6 in PANSS Marder Factor scores: disorganized thoughts
    End point description
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: disorganized thoughts is calculated from 7 items (for example: conceptual disorganization, difficulty in abstract thinking and mannerisms and posturing). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms Population Description: FAS
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    159
    150
    150
    Units: units on a scale
        arithmetic mean (standard error)
    -3.2 ( 0.4 )
    -4 ( 0.4 )
    -4.8 ( 0.3 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 6 in PANSS Marder Factor scores: uncontrolled hostility/excitement

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    End point title
    		 Change from baseline to Week 6 in PANSS Marder Factor scores: uncontrolled hostility/excitement
    End point description
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: uncontrolled hostility/excitement is calculated from 4 items (for example: excitement, hostility, and uncooperativeness).Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms Population Description: FAS
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    159
    150
    150
    Units: units on a scale
        arithmetic mean (standard error)
    -1.8 ( 0.3 )
    -2.5 ( 0.3 )
    -2.8 ( 0.3 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 6 in PANSS Marder Factor scores: anxiety/depression

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    End point title
    		 Change from baseline to Week 6 in PANSS Marder Factor scores: anxiety/depression
    End point description
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: anxiety/depression is calculated from 4 items (for example: anxiety, guilt feelings, and tension). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms Population Description: FAS
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    159
    150
    150
    Units: units on a scale
        arithmetic mean (standard error)
    -2.9 ( 0.2 )
    -3.2 ( 0.2 )
    -3.6 ( 0.2 )
    No statistical analyses for this end point

    Secondary: Discontinuation due to lack of efficacy during the study

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    End point title
    		 Discontinuation due to lack of efficacy during the study
    End point description
    Discontinuation due to lack of efficacy was based on the primary reason for withdrawal, based on all patients treated set (APTS)
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    161
    150
    153
    Units: percentage of patients
        number (not applicable)
    14.91
    6.67
    7.19
    No statistical analyses for this end point

    Secondary: Response rate at Week 6

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    End point title
    		 Response rate at Week 6
    End point description
    The response rate was defined as a reduction of ≥30% from baseline in PANSS total score OR a CGI-I score of 1 or 2 Population Description: FAS (last assessment)
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    159
    150
    150
    Units: percentage of responders
        number (not applicable)
    32.1
    48.7
    62.7
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 6 in PSP total score

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    End point title
    		 Change from baseline to Week 6 in PSP total score
    End point description
    The Personal and Social Performance Scale (PSP) is a clinician-rated scale designed and validated to measure a patient’s current level of social functioning. The PSP scale consists of a 100-point single-item rating scale, subdivided into 10 equal intervals. Scores of 1 to 10 indicate lack of autonomy in basic functioning, whereas scores of 91 to 100 reflect excellent functioning. The total score is and is based on 4 primary domains of PSP (socially useful activities (including work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours). The 4 domains are assessed on a 6-point scale, from absent to very severe. A higher score indicates a better performance. Population Description: only patients with PSP assessments between Days 15 to 27 and after Day 35 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses using LOCF
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    139
    133
    138
    Units: units on a scale
        arithmetic mean (standard error)
    9.4 ( 1 )
    13 ( 1 )
    15.3 ( 1 )
    No statistical analyses for this end point

    Secondary: PSP functional remission rate at Week 6

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    End point title
    		 PSP functional remission rate at Week 6
    End point description
    The PSP functional remission rate was defined as a PSP total score ≥71 FAS (last assessment). Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analyzed is therefore smaller than the defined FAS.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    157
    146
    146
    Units: percentage of remitters
        number (not applicable)
    5.7
    9.6
    14.4
    No statistical analyses for this end point

    Secondary: PSP functional response rate at Week 6

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    End point title
    		 PSP functional response rate at Week 6
    End point description
    The PSP functional response rate was defined as ≥10 point improvement from Baseline on the PSP total score Population Description : Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analyzed is therefore smaller than the defined FAS.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    157
    146
    146
    Units: percentage of responders
        number (not applicable)
    36.3
    53.4
    64.4
    No statistical analyses for this end point

    Secondary: PSP domain D: disturbing and aggressive behaviours at Week 6

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    End point title
    		 PSP domain D: disturbing and aggressive behaviours at Week 6
    End point description
    PSP domain D: disturbing and aggressive behaviours were categorised as “aggressive” (corresponding to mild, manifest, marked, severe, or very severe) or “nonaggressive” (corresponding to absent) Population Description: only patients who have PSP assessment at Week 6 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses where last assessment carried forward was used
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Placebo Brexpiprazole Quetiapine extended release
    Number of subjects analysed
    112
    114
    126
    Units: percentage of aggressive patients
        number (not applicable)
    30.4
    27.2
    22.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose to follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Quetiapine Extended Release
    Reporting group description
    		 -

    Reporting group title
    Brexpiprazole
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Quetiapine Extended Release Brexpiprazole
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 161 (3.73%)
    2 / 153 (1.31%)
    7 / 150 (4.67%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Grand mal convulsion
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 153 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 153 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 153 (0.00%)
    0 / 150 (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
    Psychotic disorder
         subjects affected / exposed
    1 / 161 (0.62%)
    1 / 153 (0.65%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    4 / 161 (2.48%)
    1 / 153 (0.65%)
    3 / 150 (2.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia, paranoid type
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 153 (0.00%)
    0 / 150 (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
    Suicide attempt
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 153 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 153 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 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
    		 Placebo Quetiapine Extended Release Brexpiprazole
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 161 (27.33%)
    73 / 153 (47.71%)
    48 / 150 (32.00%)
    Investigations
    Weight increased
         subjects affected / exposed
    6 / 161 (3.73%)
    20 / 153 (13.07%)
    8 / 150 (5.33%)
         occurrences all number
    6
    21
    8
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    4 / 161 (2.48%)
    6 / 153 (3.92%)
    9 / 150 (6.00%)
         occurrences all number
    5
    8
    9
    Dizziness
         subjects affected / exposed
    1 / 161 (0.62%)
    18 / 153 (11.76%)
    4 / 150 (2.67%)
         occurrences all number
    1
    21
    4
    Headache
         subjects affected / exposed
    11 / 161 (6.83%)
    9 / 153 (5.88%)
    8 / 150 (5.33%)
         occurrences all number
    12
    9
    10
    Sedation
         subjects affected / exposed
    5 / 161 (3.11%)
    8 / 153 (5.23%)
    4 / 150 (2.67%)
         occurrences all number
    5
    8
    4
    Somnolence
         subjects affected / exposed
    8 / 161 (4.97%)
    34 / 153 (22.22%)
    7 / 150 (4.67%)
         occurrences all number
    8
    45
    8
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    2 / 161 (1.24%)
    13 / 153 (8.50%)
    2 / 150 (1.33%)
         occurrences all number
    2
    14
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    10 / 161 (6.21%)
    4 / 153 (2.61%)
    13 / 150 (8.67%)
         occurrences all number
    11
    5
    18
    Schizophrenia
         subjects affected / exposed
    11 / 161 (6.83%)
    4 / 153 (2.61%)
    6 / 150 (4.00%)
         occurrences all number
    11
    6
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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