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    Clinical Trial Results:
    Interventional, Open-label, Flexible-dose Extension Study of Brexpiprazole in Patients With Schizophrenia

    Summary
    EudraCT number
    		 2012-002705-21
    Trial protocol
    		 CZ   EE   SK   PL   RO  
    Global end of trial date
    30 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jan 2017
    First version publication date
    14 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    14644B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01810783
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark, 2500
    Public contact
    LundbeckClinicalTrials@lundbeck.com , H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    LundbeckClinicalTrials@lundbeck.com , 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
    30 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the safety and efficacy of brexpiprazole during long-term treatment
    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
    12 Jul 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
    United States: 50
    Country: Number of subjects enrolled
    Estonia: 6
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    Romania: 9
    Country: Number of subjects enrolled
    Russian Federation: 52
    Country: Number of subjects enrolled
    Serbia: 19
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    Ukraine: 64
    Worldwide total number of subjects
    210
    EEA total number of subjects
    25
    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)
    209
    From 65 to 84 years
    1
    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
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Brexpiprazole
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brexpiprazole
    Investigational medicinal product code
    Other name
    Rexulti
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).

    Number of subjects in period 1
    		Brexpiprazole
    Started
    210
    Completed
    101
    Not completed
    109
         Consent withdrawn by subject
    22
         Adverse event, non-fatal
    32
         Adminstrative or other reasons(s)
    23
         Lost to follow-up
    10
         Non-compliance with IMP
    4
         Lack of efficacy
    12
         Protocol deviation
    5
         Not treated
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 210 210
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 209 209
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.89 ( 11.35 ) -
    Gender categorical
    Units: Subjects
        Female
    		 113 113
        Male
    		 97 97
    Race
    Units: Subjects
        White
    		 173 173
        Black or African American
    		 35 35
        Other
    		 1 1
        Native Hawaiian Or Other
    		 1 1

    End points

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

    Primary: Safety and tolerability

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    End point title
    		 Safety and tolerability [1]
    End point description
    Number of treatment emergent adverse events (TEAEs)
    End point type
    Primary
    End point timeframe
    Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP)
    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 comparison between parameters were done
    End point values
    		 Brexpiprazole
    Number of subjects analysed
    209
    Units: Number
    337
    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
    Brex
    Reporting group description
    		 Brex

    Serious adverse events
    		 Brex
    Total subjects affected by serious adverse events
         subjects affected / exposed
    31 / 209 (14.83%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung carcinoma cell type unspecified stage iv
         subjects affected / exposed
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Grand mal convulsion
         subjects affected / exposed
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed [1]
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Social circumstances
    Social stay hospitalisation
         subjects affected / exposed
    2 / 209 (0.96%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Panic attack
         subjects affected / exposed
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    2 / 209 (0.96%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Schizophrenia
         subjects affected / exposed
    18 / 209 (8.61%)
         occurrences causally related to treatment / all
    6 / 18
         deaths causally related to treatment / all
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    2 / 209 (0.96%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Peritonsillar abscess
         subjects affected / exposed
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific adverse event
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Brex
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 209 (22.49%)
    Investigations
    Weight increased
         subjects affected / exposed
    22 / 209 (10.53%)
         occurrences all number
    23
    Nervous system disorders
    Headache
         subjects affected / exposed
    18 / 209 (8.61%)
         occurrences all number
    21
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    17 / 209 (8.13%)
         occurrences all number
    21

    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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    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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