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    Clinical Trial Results:
    A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects with Schizophrenia

    Summary
    EudraCT number
    		 2015-003880-13
    Trial protocol
    		 SK   HU   BG  
    Global end of trial date
    18 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jul 2019
    First version publication date
    04 Jul 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ALK3831-A306
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02669758
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alkermes
    Sponsor organisation address
    852 Winter Street, Waltham, United States, 02451
    Public contact
    Eva Stroynowski, Alkermes Inc, ++1 718609-7000, eva.stroynowski@alkermes.com
    Scientific contact
    Eva Stroynowski, Alkermes Inc, ++1 718609-7000, eva.stroynowski@alkermes.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
    12 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
    Protection of trial subjects
    This trial was conducted in compliance with Good Clinical Practice (GCP) guidelines for conducting clinical trials. The informed consent form (ICF), protocol, and amendments were reviewed and approved by the institutional review board (IRB) or independent ethics committee (IEC) for each clinical trial site.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 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
    Bulgaria: 100
    Country: Number of subjects enrolled
    United States: 75
    Country: Number of subjects enrolled
    Ukraine: 69
    Country: Number of subjects enrolled
    Serbia: 33
    Worldwide total number of subjects
    277
    EEA total number of subjects
    100
    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)
    273
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who completed the 4-week treatment period of the antecedent study, ALK3831-A305, were eligible to be enrolled in Study ALK3831-A306 within 7 days of their last study visit in ALK3831-A305.

    Pre-assignment
    Screening details
    		 A total of 4 subjects enrolled but were not dosed. Three subjects were lost-to-follow-up prior to receiving study drug, and one subject was not compliant with study drug. A total of 277 patients were administered at least one dose of ALKS 3831 and were included in the safety population.

    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
    		 ALKS 3831
    Arm description
    		 Olanzapine + samidorphan; administered as a coated bilayer tablet
    Arm type
    		 Experimental

    Investigational medicinal product name
    ALKS 3831
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets were administered for daily dosing

    Number of subjects in period 1
    		ALKS 3831
    Started
    277
    Completed
    183
    Not completed
    94
         Consent withdrawn by subject
    43
         Non-Compliance with Study Drug
    8
         Adverse event, non-fatal
    16
         Pregnancy
    1
         Study non-compliance
    1
         Lost to follow-up
    19
         Lack of efficacy
    5
         Protocol deviation
    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
    		 277 277
    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)
    		 41.4 ± 11.31 -
    Gender categorical
    Units: Subjects
        Female
    		 116 116
        Male
    		 161 161
    Subject analysis sets

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population includes all subjects who received at least one dose of study drug.

    Subject analysis sets values
    		 Safety Population
    Number of subjects
    277
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    41.4 ± 11.31
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    ALKS 3831
    Reporting group description
    		 Olanzapine + samidorphan; administered as a coated bilayer tablet

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population includes all subjects who received at least one dose of study drug.

    Primary: Incidence of Adverse Events

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    End point title
    		 Incidence of Adverse Events [1]
    End point description
    Safety population includes all subjects who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    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: Summary statistics were conducted for the primary endpoint, and have been included.
    End point values
    		 ALKS 3831
    Number of subjects analysed
    277
    Units: Participants
    136
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 52 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    ALKS 3831
    Reporting group description
    		 Administered as a coated bilayer tablet; ALKS 3831: Daily dosing

    Serious adverse events
    		 ALKS 3831
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 277 (2.89%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Fibula fracture
         subjects affected / exposed
    1 / 277 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intentional overdose
         subjects affected / exposed
    1 / 277 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 277 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    5 / 277 (1.81%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 277 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    1 / 277 (0.36%)
         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
    		 ALKS 3831
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    102 / 277 (36.82%)
    Investigations
    Blood insulin increased
         subjects affected / exposed
    6 / 277 (2.17%)
         occurrences all number
    6
    Blood prolactin increased
         subjects affected / exposed
    6 / 277 (2.17%)
         occurrences all number
    6
    Weight decreased
         subjects affected / exposed
    6 / 277 (2.17%)
         occurrences all number
    6
    Weight increased
         subjects affected / exposed
    37 / 277 (13.36%)
         occurrences all number
    40
    Injury, poisoning and procedural complications
    Extra dose administered
    Additional description: Resulted from the errors made by the subjects or caregivers while taking the study medication
         subjects affected / exposed
    9 / 277 (3.25%)
         occurrences all number
    11
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 277 (3.97%)
         occurrences all number
    13
    Somnolence
         subjects affected / exposed
    23 / 277 (8.30%)
         occurrences all number
    27
    Social circumstances
    Social stay hospitalisation
    Additional description: Per protocol social stay hospitalisations were not considered Serious Adverse Events, and were recorded as AEs
         subjects affected / exposed
    7 / 277 (2.53%)
         occurrences all number
    7
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    7 / 277 (2.53%)
         occurrences all number
    9
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    7 / 277 (2.53%)
         occurrences all number
    7
    Insomnia
         subjects affected / exposed
    6 / 277 (2.17%)
         occurrences all number
    6
    Schizophrenia
         subjects affected / exposed
    6 / 277 (2.17%)
         occurrences all number
    6
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    11 / 277 (3.97%)
         occurrences all number
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Mar 2016
    Updated laboratory parameters, and added clarification lanauge
    25 Apr 2017
    Clarification language added surrounding end of study visits; dosage and administration details were updated.

    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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