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    Clinical Trial Results:
    A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study

    Summary
    EudraCT number
    		 2011-000682-12
    Trial protocol
    		 SK   LT   CZ  
    Global end of trial date
    01 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Oct 2016
    First version publication date
    15 Oct 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D1050298
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01485640
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sunovion Pharmaceuticals Inc.
    Sponsor organisation address
    One Bridge Plaza North, Suite 510, Fort Lee, United States, 07024
    Public contact
    Medical Director, Sunovion Pharmaceuticals Inc., 001 1-866-503-6351 , clinicaltrialdisclosure@sunovion.com
    Scientific contact
    Medical Director, Sunovion Pharmaceuticals Inc., 001 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
    01 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.
    Protection of trial subjects
    The study was conducted according to the protocol, International Conference on 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
    01 Jun 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
    Serbia: 6
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Czech Republic: 25
    Country: Number of subjects enrolled
    Slovakia: 17
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Ukraine: 11
    Country: Number of subjects enrolled
    Romania: 2
    Country: Number of subjects enrolled
    Lithuania: 8
    Country: Number of subjects enrolled
    Russian Federation: 20
    Country: Number of subjects enrolled
    South Africa: 26
    Country: Number of subjects enrolled
    Colombia: 6
    Country: Number of subjects enrolled
    India: 32
    Worldwide total number of subjects
    162
    EEA total number of subjects
    58
    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)
    1
    Adults (18-64 years)
    159
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Continuation study designed to monitor safety,tolerability and effectiveness of lurasidone in subjects who completed participation in a lurasidone extension study and who may benefit from continued treatment with lurasidone.Eligible subjects could enroll into this continuation study directly (or within 14 days) after completing the extension study

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Lurasidone
    Arm description
    		 Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
    Arm type
    		 Experimental

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

    Number of subjects in period 1
    		Lurasidone
    Started
    162
    Completed
    40
    Not completed
    122
         Terminated by Sponsor
    95
         Consent withdrawn by subject
    14
         Adverse event, non-fatal
    10
         Lack of efficacy
    2
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lurasidone
    Reporting group description
    		 Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food

    Reporting group values
    		 Lurasidone Total
    Number of subjects
    		 162 162
    Age Categorical
    Units: participants
        <=18 years
    		 1 1
        Between 18 and 65 years
    		 159 159
        >=65 years
    		 2 2
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.3 ± 12.08 -
    Gender, Male/Female
    Units: participants
        Female
    		 77 77
        Male
    		 85 85
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 32 32
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 5 5
        White
    		 105 105
        More than one race
    		 0 0
        Unknown or Not Reported
    		 20 20
    Region of Enrollment
    Units: Subjects
        Serbia
    		 6 6
        France
    		 6 6
        Czech Republic
    		 25 25
        Slovakia
    		 17 17
        Canada
    		 3 3
        Ukraine
    		 11 11
        Romania
    		 2 2
        Lithuania
    		 8 8
        Russian Federation
    		 20 20
        South Africa
    		 26 26
        Colombia
    		 6 6
        India
    		 32 32

    End points

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    End points reporting groups
    Reporting group title
    Lurasidone
    Reporting group description
    		 Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food

    Primary: Number of subjects with treatment emergent AEs, SAEs or who discontinued due to AEs

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    End point title
    		 Number of subjects with treatment emergent AEs, SAEs or who discontinued due to AEs [1]
    End point description
    End point type
    Primary
    End point timeframe
    18 months
    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: this is an extended use study, and every subject took lurasidone during the study, and thus only one treatment group is reported and no statistical analyses can be performed.
    End point values
    		 Lurasidone
    Number of subjects analysed
    162
    Units: number of participants
        Subject with at least on treatment emergent AE
    63
        Subject with at least one treatment emergent SAE
    7
        Subjects discontinued due to TEAE
    1
    No statistical analyses for this end point

    Secondary: Change from baseline to Month 18 (LOCF) in the Clinical Global Impression Severity score (CGI-S

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    End point title
    		 Change from baseline to Month 18 (LOCF) in the Clinical Global Impression Severity score (CGI-S
    End point description
    The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.
    End point type
    Secondary
    End point timeframe
    18 months
    End point values
    		 Lurasidone
    Number of subjects analysed
    153
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.18 ± 0.877
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    18 Months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Lurasidone
    Reporting group description
    		 Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food

    Serious adverse events
    		 Lurasidone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 162 (4.32%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Depression suicidal
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Mania
         subjects affected / exposed
    2 / 162 (1.23%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Schizophrenia, paranoid type
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pilonidal cyst
         subjects affected / exposed
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Lurasidone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 162 (24.69%)
    Investigations
    Hepatic enzyme increase
         subjects affected / exposed
    4 / 162 (2.47%)
         occurrences all number
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 162 (5.56%)
         occurrences all number
    12
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 162 (3.70%)
         occurrences all number
    8
    Vomiting
         subjects affected / exposed
    5 / 162 (3.09%)
         occurrences all number
    11
    Nausea
         subjects affected / exposed
    4 / 162 (2.47%)
         occurrences all number
    4
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    5 / 162 (3.09%)
         occurrences all number
    11
    Insomnia
         subjects affected / exposed
    5 / 162 (3.09%)
         occurrences all number
    6
    Depression
         subjects affected / exposed
    4 / 162 (2.47%)
         occurrences all number
    4
    Infections and infestations
    Influenza
         subjects affected / exposed
    6 / 162 (3.70%)
         occurrences all number
    6
    Nasopharyngitis
         subjects affected / exposed
    6 / 162 (3.70%)
         occurrences all number
    9
    Viral upper respiratory tract infection
         subjects affected / exposed
    4 / 162 (2.47%)
         occurrences all number
    4

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

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