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    Clinical Trial Results:
    A 6-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lurasidone (SM-13496) in Acutely Psychotic Subjects with Schizophrenia

    Summary
    EudraCT number
    		 2016-000060-42
    Trial protocol
    		 SK   PL  
    Global end of trial date
    06 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2019
    First version publication date
    27 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D1001066
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sunovion Pharmaceuticals Inc.
    Sponsor organisation address
    84 Waterford Drive, Marlborough, United States, 01752
    Public contact
    CNS Medical Director, Sunovion Pharmaceuticals Inc., +1 866-503-6351, clinicaltrialdisclosure@sunovion.com
    Scientific contact
    CNS Medical Director, Sunovion Pharmaceuticals Inc., +1 866-503-6351, clinicaltrialdisclosure@sunovion.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
    06 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of lurasidone (SM-13496) 40 mg/day compared with placebo in acutely psychotic subjects with schizophrenia as measured by change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 6.
    Protection of trial subjects
    THE STUDY WAS CONDUCTED ACCORDING TO THE PROTOCOL, INTERNATIONAL COUNCIL FOR HARMONISATION (ICH) GOOD CLINICAL PRACTICE (GCP), ICH GUIDELINES, AND THE ETHICAL PRINCIPLES THAT HAVE THEIR ORIGIN IN THE DECLARATION OF HELSINKI.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 May 2016
    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
    Poland: 9
    Country: Number of subjects enrolled
    Romania: 23
    Country: Number of subjects enrolled
    Japan: 107
    Country: Number of subjects enrolled
    Russian Federation: 147
    Country: Number of subjects enrolled
    Ukraine: 196
    Worldwide total number of subjects
    482
    EEA total number of subjects
    32
    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)
    472
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The Screening phase for each subject will begin at the time that the subject provides written informed consent. Subjects will be evaluated for eligibility during a screening period of up to 14 days, during which they will be tapered off all psychotropic medications(except as noted in this protocol)in a manner consistent with labeling recommendation

    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
    		 Investigator, Carer, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 lurasidone
    Arm description
    		 Lurasidone 40 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    lurasidone
    Investigational medicinal product code
    Other name
    Latuda
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    lurasidone 40mg dosed once daily

    Arm title
    		 Placebo
    Arm description
    		 placebo
    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
    placebo once daily

    Investigational medicinal product name
    lurasidone
    Investigational medicinal product code
    Other name
    Latuda
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    lurasidone 40mg dosed once daily

    Number of subjects in period 1
    		lurasidone Placebo
    Started
    247
    235
    Completed
    199
    175
    Not completed
    48
    60
         Consent withdrawn by subject
    23
    20
         Adverse event, non-fatal
    14
    15
         Lack of efficacy
    10
    24
         need reason
    1
    -
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    lurasidone
    Reporting group description
    		 Lurasidone 40 mg

    Reporting group title
    Placebo
    Reporting group description
    		 placebo

    Reporting group values
    		 lurasidone Placebo Total
    Number of subjects
    		 247 235 482
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 241 231 472
        From 65-84 years
    		 6 4 10
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.0 ( 11.0 ) 39.3 ( 11.44 ) -
    Gender categorical
    Units: Subjects
        Female
    		 127 114 241
        Male
    		 120 121 241

    End points

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    End points reporting groups
    Reporting group title
    lurasidone
    Reporting group description
    		 Lurasidone 40 mg

    Reporting group title
    Placebo
    Reporting group description
    		 placebo

    Primary: Change from Baseline in PANSS total score

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    End point title
    		 Change from Baseline in PANSS total score
    End point description
    End point type
    Primary
    End point timeframe
    week 6
    End point values
    		 lurasidone Placebo
    Number of subjects analysed
    245 [1]
    233 [2]
    Units: units on a scale
        least squares mean (standard error)
    -19.3 ( 1.10 )
    -12.7 ( 1.15 )
    Notes
    [1] - ITT population
    [2] - ITT population
    Statistical analysis title
    		 primary endpoint
    Comparison groups
    lurasidone v Placebo
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (net)
    Point estimate
    -6.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.7
         upper limit
    		 -3.5
    Notes
    [3] - the Kenward-Roger’s approximation will be used to calculate the denominator degree of freedom.

    Secondary: Change from Baseline in PANSS total score at Weeks 1, 2, 3, 4 and 5

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    End point title
    		 Change from Baseline in PANSS total score at Weeks 1, 2, 3, 4 and 5
    End point description
    End point type
    Secondary
    End point timeframe
    up to week 5
    End point values
    		 lurasidone Placebo
    Number of subjects analysed
    245
    233
    Units: units on a scale
    least squares mean (standard error)
        Week 1
    -5.5 ( 0.57 )
    -4.5 ( 0.59 )
        Week 2
    -10.2 ( 0.75 )
    -6.6 ( 0.77 )
        Week 3
    -13.1 ( 0.85 )
    -8.6 ( 0.89 )
        Week 4
    -16.3 ( 0.95 )
    -10.8 ( 0.99 )
        Week 5
    -18.0 ( 0.99 )
    -11.9 ( 1.04 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in PANSS Subscale Score - Positive Scale

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    End point title
    		 Change from Baseline in PANSS Subscale Score - Positive Scale
    End point description
    End point type
    Secondary
    End point timeframe
    up to week 6
    End point values
    		 lurasidone Placebo
    Number of subjects analysed
    245
    233
    Units: units on a scale
    least squares mean (standard error)
        Week 1
    -1.8 ( 0.19 )
    -1.4 ( 0.20 )
        Week 2
    -3.3 ( 0.24 )
    -2.2 ( 0.25 )
        Week 3
    -4.3 ( 0.28 )
    -2.7 ( 0.29 )
        Week 4
    -5.1 ( 0.32 )
    -3.5 ( 0.33 )
        Week 5
    -5.6 ( 0.32 )
    -3.8 ( 0.33 )
        Week 6
    -6.1 ( 0.35 )
    -3.9 ( 0.37 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in CGI-S Score at Weeks 1,2,3,4,5, and 6

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    End point title
    		 Change from Baseline in CGI-S Score at Weeks 1,2,3,4,5, and 6
    End point description
    End point type
    Secondary
    End point timeframe
    up to week 6
    End point values
    		 lurasidone Placebo
    Number of subjects analysed
    245
    233
    Units: units on a scale
    least squares mean (standard error)
        Week 1
    -0.21 ( 0.036 )
    -0.19 ( 0.037 )
        Week 2
    -0.49 ( 0.045 )
    -0.33 ( 0.047 )
        Week 3
    -0.67 ( 0.048 )
    -0.48 ( 0.050 )
        Week 4
    -0.84 ( 0.053 )
    -0.59 ( 0.056 )
        Week 5
    -0.91 ( 0.057 )
    -0.63 ( 0.060 )
        Week 6
    -1.03 ( 0.063 )
    -0.66 ( 0.066 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in PANSS Subscale Scores-Negative Scale

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    End point title
    		 Change from Baseline in PANSS Subscale Scores-Negative Scale
    End point description
    End point type
    Secondary
    End point timeframe
    up to week 6
    End point values
    		 lurasidone Placebo
    Number of subjects analysed
    245
    233
    Units: Units on a scale
    least squares mean (standard error)
        Week 1
    -0.8 ( 0.16 )
    -0.7 ( 0.16 )
        Week 2
    -1.4 ( 0.19 )
    -0.9 ( 0.20 )
        Week 3
    -2.2 ( 0.21 )
    -1.6 ( 0.22 )
        Week 4
    -2.8 ( 0.23 )
    -1.7 ( 0.24 )
        Week 5
    -2.9 ( 0.25 )
    -1.9 ( 0.26 )
        Week 6
    -3.3 ( 0.26 )
    -2.5 ( 0.27 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in PANSS Subscale Score -General Psychopathology Scale

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    End point title
    		 Change from Baseline in PANSS Subscale Score -General Psychopathology Scale
    End point description
    End point type
    Secondary
    End point timeframe
    up to week 6
    End point values
    		 lurasidone Placebo
    Number of subjects analysed
    245
    233
    Units: Units on a scale
    least squares mean (standard error)
        Week 1
    -2.9 ( 0.33 )
    -2.4 ( 0.34 )
        Week 2
    -5.4 ( 0.41 )
    -3.6 ( 0.42 )
        Week 3
    -6.7 ( 0.45 )
    -4.5 ( 0.47 )
        Week 4
    -8.5 ( 0.49 )
    -5.8 ( 0.52 )
        Week 5
    -9.5 ( 0.53 )
    -6.5 ( 0.56 )
        Week 6
    -10.0 ( 0.53 )
    -6.8 ( 0.61 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in PANSS 5-factor models scores-negative symptoms

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    End point title
    		 Change from Baseline in PANSS 5-factor models scores-negative symptoms
    End point description
    The PANSS 5-factor model was defined as follows: - Negative symptoms: Blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of spontaneity and flow of conversation, and active social avoidance. The PANSS response defined as 20% or greater improvement from Baseline in PANSS total score.
    End point type
    Secondary
    End point timeframe
    up to week 6
    End point values
    		 lurasidone Placebo
    Number of subjects analysed
    245
    233
    Units: Units on a scale
    least squares mean (standard error)
        Week 1
    -0.8 ( 0.15 )
    -0.7 ( 0.15 )
        Week 2
    -1.6 ( 0.18 )
    -1.0 ( 0.18 )
        Week 3
    -2.3 ( 0.20 )
    -1.8 ( 0.21 )
        Week 4
    -2.8 ( 0.22 )
    -1.8 ( 0.23 )
        Week 5
    -3.0 ( 0.24 )
    -2.1 ( 0.25 )
        Week 6
    -3.4 ( 0.26 )
    -2.6 ( 0.27 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in PANSS 5-factor model scores-Excitement

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    End point title
    		 Change from Baseline in PANSS 5-factor model scores-Excitement
    End point description
    The PANSS 5-factor model was defined as follows: - Excitement: Excitement, hostility, tension, and poor impulse control.
    End point type
    Secondary
    End point timeframe
    up to week 6
    End point values
    		 lurasidone Placebo
    Number of subjects analysed
    245
    233
    Units: Units on a scale
    least squares mean (standard error)
        Week 1
    -0.8 ( 0.14 )
    -0.5 ( 0.14 )
        Week 2
    -1.5 ( 0.17 )
    -1.0 ( 0.17 )
        Week 3
    -1.7 ( 0.18 )
    -1.1 ( 0.19 )
        Week 4
    -2.1 ( 0.19 )
    -1.4 ( 0.20 )
        Week 5
    -2.4 ( 0.20 )
    -1.4 ( 0.21 )
        Week 6
    -2.5 ( 0.21 )
    -1.5 ( 0.22 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in PANSS 5-factor model scores-Cognitive Disorders

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    End point title
    		 Change from Baseline in PANSS 5-factor model scores-Cognitive Disorders
    End point description
    The PANSS 5-factor model was defined as follows: - Cognitive disorders: Conceptual disorganization, difficulty in abstract thinking, mannerisms and posturing, disorientation, and poor attention.
    End point type
    Secondary
    End point timeframe
    up to Week 6
    End point values
    		 lurasidone Placebo
    Number of subjects analysed
    245
    233
    Units: Units on a scale
    least squares mean (standard error)
        Week 1
    -0.5 ( 0.11 )
    -0.5 ( 0.11 )
        Week 2
    -1.1 ( 0.13 )
    -0.7 ( 0.14 )
        Week 3
    -1.5 ( 0.15 )
    -0.9 ( 0.16 )
        Week 4
    -2.0 ( 0.16 )
    -1.3 ( 0.16 )
        Week 5
    -2.2 ( 0.16 )
    -1.5 ( 0.17 )
        Week 6
    -2.4 ( 0.17 )
    -1.6 ( 0.18 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in PANSS 5-factor model scores-Positive Symptoms

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    End point title
    		 Change from Baseline in PANSS 5-factor model scores-Positive Symptoms
    End point description
    The PANSS 5-factor model was defined as follows: - Positive symptoms: Delusions, grandiosity, suspiciousness/persecution, and unusual thought content.
    End point type
    Secondary
    End point timeframe
    up to Week 6
    End point values
    		 lurasidone Placebo
    Number of subjects analysed
    245
    233
    Units: Units on a scale
    least squares mean (standard error)
        Week 1
    -1.0 ( 0.12 )
    -1.0 ( 0.12 )
        Week 2
    -1.9 ( 0.15 )
    -1.4 ( 0.16 )
        Week 3
    -2.5 ( 0.17 )
    -1.7 ( 0.18 )
        Week 4
    -3.0 ( 0.19 )
    -2.2 ( 0.20 )
        Week 5
    -3.4 ( 0.20 )
    -2.5 ( 0.21 )
        Week 6
    -3.7 ( 0.22 )
    -2.4 ( 0.23 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in PANSS 5-factor model scores - Anxiety/Depression

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    End point title
    		 Change from Baseline in PANSS 5-factor model scores - Anxiety/Depression
    End point description
    The PANSS 5-factor model was defined as follows: - Anxiety/depression: Somatic concern, anxiety, guilt feelings, depression, and preoccupation.
    End point type
    Secondary
    End point timeframe
    Up to week 6
    End point values
    		 lurasidone Placebo
    Number of subjects analysed
    245
    233
    Units: Units on a scale
    least squares mean (standard error)
        Week 1
    -1.5 ( 0.15 )
    -1.0 ( 0.16 )
        Week 2
    -2.2 ( 0.18 )
    -1.4 ( 0.19 )
        Week 3
    -2.7 ( 0.19 )
    -2.0 ( 0.20 )
        Week 4
    -3.4 ( 0.20 )
    -2.6 ( 0.21 )
        Week 5
    -3.7 ( 0.21 )
    -2.8 ( 0.22 )
        Week 6
    -4.0 ( 0.22 )
    -2.9 ( 0.23 )
    No statistical analyses for this end point

    Secondary: Proportion of subjects who achieved a PANSS response Week 6 (LOCF)

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    End point title
    		 Proportion of subjects who achieved a PANSS response Week 6 (LOCF)
    End point description
    Proportion of subjects who achieve a response, defined as 20% or greater improvement from Baseline in PANSS total score at Week 6 last observation carried forward (LOCF) endpoint;of
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 lurasidone Placebo
    Number of subjects analysed
    245
    233
    Units: percent of participants
        percentage
    60
    42
    No statistical analyses for this end point

    Secondary: Change from baseline in CDSS total score -Week 3

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    End point title
    		 Change from baseline in CDSS total score -Week 3
    End point description
    End point type
    Secondary
    End point timeframe
    Week 3
    End point values
    		 lurasidone Placebo
    Number of subjects analysed
    245
    233
    Units: Units on a scale
        least squares mean (standard error)
    -1.43 ( 0.165 )
    -1.17 ( 0.175 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    lurasidone
    Reporting group description
    		 Lurasidone 40 mg

    Reporting group title
    Placebo
    Reporting group description
    		 placebo

    Serious adverse events
    		 lurasidone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 247 (0.81%)
    4 / 235 (1.70%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Hand fracture
         subjects affected / exposed
    0 / 247 (0.00%)
    1 / 235 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    2 / 247 (0.81%)
    2 / 235 (0.85%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 247 (0.00%)
    1 / 235 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 lurasidone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    114 / 247 (46.15%)
    119 / 235 (50.64%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 247 (6.07%)
    11 / 235 (4.68%)
         occurrences all number
    17
    12
    Anxiety
         subjects affected / exposed
    8 / 247 (3.24%)
    16 / 235 (6.81%)
         occurrences all number
    12
    21
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    15 / 247 (6.07%)
    27 / 235 (11.49%)
         occurrences all number
    16
    32
    Schizophrenia
         subjects affected / exposed
    13 / 247 (5.26%)
    21 / 235 (8.94%)
         occurrences all number
    14
    22

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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