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    Clinical Trial Results:
    A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects with Stable Schizophrenia

    Summary
    EudraCT number
    		 2012-003996-20
    Trial protocol
    		 BG  
    Global end of trial date
    28 Apr 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    ALK9072-003EXT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01626456
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alkermes
    Sponsor organisation address
    852 Winter Street, Waltham, United States, 02451
    Public contact
    ARISTADA Medical Information, Alkermes, Inc., 01 866-274-7823, usmedinfo@alkermes.com
    Scientific contact
    ARISTADA Medical Information, Alkermes, Inc., 01 866-274-7823, usmedinfo@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
    03 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.
    Protection of trial subjects
    Laboratory results for new subjects were reviewed before the first dose of ALKS 9072 was administered. Study visits occurred once every 4 weeks for a maximum of 16 study visits in addition to routine visits for clinical care. All subjects received study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2012
    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
    Russian Federation: 80
    Country: Number of subjects enrolled
    Romania: 5
    Country: Number of subjects enrolled
    United States: 130
    Country: Number of subjects enrolled
    Philippines: 49
    Country: Number of subjects enrolled
    Ukraine: 122
    Country: Number of subjects enrolled
    Korea, Republic of: 6
    Country: Number of subjects enrolled
    Malaysia: 24
    Country: Number of subjects enrolled
    Bulgaria: 62
    Worldwide total number of subjects
    478
    EEA total number of subjects
    67
    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)
    474
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who successfully completed the Day 85 visit in Study ALK9072-003 and continued to meet eligibility criteria were eligible to enroll in this extension study. In addition, adults with chronic stable schizophrenia on a stable oral antipsychotic medication not previously enrolled in Study ALK9072-003 were also eligible to enroll.

    Pre-assignment
    Screening details
    		 While there were only 2 treatment groups in this extension study, data for several outcome measures is presented by lead-in study groups, and separated into 5 categories: PBO-441 mg, 441-441 mg, PBO-882 mg, 882-882 mg, and de novo.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    The study blind was maintained for those subjects who participated in the ALK9072-003 study. The investigator and study site staff were not informed about whether a given subject had been previously assigned to ALKS 9072 or to placebo in Study ALK9072-003. Subjects who participated in the ALK9072-003 were not informed of the dose of ALKS 9072 administered in either study. Only the unblinded pharmacist and the individual performing the injection were aware of the volume of ALKS 9072.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ALKS 9072, 441 mg
    Arm description
    		 ALKS 9072, IM injection, given monthly
    Arm type
    		 Experimental

    Investigational medicinal product name
    ALKS 9072
    Investigational medicinal product code
    Other name
    ARISTADA, aripiprazole lauroxil
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    441 mg IM injection, administered every 4 weeks

    Arm title
    		 ALKS 9072, 882 mg
    Arm description
    		 ALKS 9072, IM injection, given monthly
    Arm type
    		 Experimental

    Investigational medicinal product name
    ALKS 9072
    Investigational medicinal product code
    Other name
    ARISTADA, aripiprazole lauroxil
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    882 mg IM injection, administered every 4 weeks

    Number of subjects in period 1
    		ALKS 9072, 441 mg ALKS 9072, 882 mg
    Started
    110
    368
    Completed
    75
    251
    Not completed
    35
    117
         Site Closure
    2
    3
         Consent withdrawn by subject
    21
    46
         Physician decision
    1
    4
         Adverse event, non-fatal
    2
    27
         Incarceration
    -
    2
         Lost to follow-up
    2
    27
         Lack of efficacy
    6
    7
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ALKS 9072, 441 mg
    Reporting group description
    		 ALKS 9072, IM injection, given monthly

    Reporting group title
    ALKS 9072, 882 mg
    Reporting group description
    		 ALKS 9072, IM injection, given monthly

    Reporting group values
    		 ALKS 9072, 441 mg ALKS 9072, 882 mg Total
    Number of subjects
    		 110 368 478
    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)
    		 109 365 474
        From 65-84 years
    		 1 3 4
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.1 ( 10.88 ) 39.8 ( 11.76 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 45 158 203
        Male
    		 65 210 275
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 20 59 79
        Native Hawaiian or Other Pacific Islander
    		 0 2 2
        Black or African American
    		 13 79 92
        White
    		 77 228 305
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        Russian Federation
    		 20 60 80
        Romania
    		 3 2 5
        United States
    		 19 111 130
        Philippines
    		 17 32 49
        Ukraine
    		 29 93 122
        Korea, Republic of
    		 0 6 6
        Malaysia
    		 3 21 24
        Bulgaria
    		 19 43 62

    End points

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    End points reporting groups
    Reporting group title
    ALKS 9072, 441 mg
    Reporting group description
    		 ALKS 9072, IM injection, given monthly

    Reporting group title
    ALKS 9072, 882 mg
    Reporting group description
    		 ALKS 9072, IM injection, given monthly

    Subject analysis set title
    PBO-441 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who received placebo in the base study and ALKS 9072 441 mg in the current study.

    Subject analysis set title
    441-441 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who received ALKS 441 mg in both the base study and the current study.

    Subject analysis set title
    PBO-882 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who received placebo in the base study and ALKS 9072 882 mg in the current study.

    Subject analysis set title
    882-882 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who received ALKS 9072 882 mg in both the base study and the current study.

    Subject analysis set title
    De Novo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who did not participate in the base study. These subjects received ALKS 9072 882 mg in the current study.

    Primary: Number of subjects with treatment-emergent adverse events (TEAEs)

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    End point title
    		 Number of subjects with treatment-emergent adverse events (TEAEs) [1]
    End point description
    The safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study. This measure includes incidences >5%
    End point type
    Primary
    End point timeframe
    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: The endpoint measures incidence; statistical analysis is not applicable.
    End point values
    		 ALKS 9072, 441 mg ALKS 9072, 882 mg
    Number of subjects analysed
    110
    368
    Units: participants
        number (not applicable)
    51
    190
    No statistical analyses for this end point

    Secondary: Mean change from baseline to endpoint in Clinical Global Impression Scale for Severity (CGI-S)

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    End point title
    		 Mean change from baseline to endpoint in Clinical Global Impression Scale for Severity (CGI-S)
    End point description
    The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data.
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 PBO-441 mg 441-441 mg PBO-882 mg 882-882 mg De Novo
    Number of subjects analysed
    29
    80
    26
    94
    233
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.9 ( 0.68 )
    -0.5 ( 0.71 )
    -0.8 ( 0.85 )
    -0.3 ( 0.61 )
    -0.2 ( 0.61 )
    No statistical analyses for this end point

    Secondary: Discontinuation from study due to Adverse Events (AEs)

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    End point title
    		 Discontinuation from study due to Adverse Events (AEs)
    End point description
    Number of subjects who discontinued the study due to AE.
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 ALKS 9072, 441 mg ALKS 9072, 882 mg
    Number of subjects analysed
    110
    368
    Units: participants
        number (not applicable)
    2
    27
    No statistical analyses for this end point

    Secondary: Suicidal ideation and behavior using the Columbia Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Suicidal ideation and behavior using the Columbia Suicide Severity Rating Scale (C-SSRS)
    End point description
    The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 PBO-441 mg 441-441 mg PBO-882 mg 882-882 mg De Novo
    Number of subjects analysed
    29
    81
    26
    100
    242
    Units: participants
    number (not applicable)
        Any suicidal ideation
    0
    1
    1
    1
    4
        Any suicidal behavior
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Mean change from Baseline to Endpoint using the Positive and Negative Symptom Scale (PANSS) total score and subscale scores

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    End point title
    		 Mean change from Baseline to Endpoint using the Positive and Negative Symptom Scale (PANSS) total score and subscale scores
    End point description
    This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 PBO-441 mg 441-441 mg PBO-882 mg 882-882 mg De Novo
    Number of subjects analysed
    29
    80
    26
    94
    233
    Units: units on a scale
    arithmetic mean (standard deviation)
        Total Score
    -19.1 ( 15.5 )
    -10 ( 10.2 )
    -11.6 ( 11.7 )
    -8.3 ( 8.2 )
    -5.9 ( 8.3 )
        Positive Subscale Score
    -5.8 ( 6 )
    -3.4 ( 3.4 )
    -4.1 ( 4.1 )
    -2.3 ( 3.1 )
    -1.8 ( 2.8 )
        Negative Subscale Score
    -4.1 ( 4.2 )
    -1.5 ( 3.5 )
    -1.6 ( 3.8 )
    -2.1 ( 3 )
    -1.2 ( 3.3 )
        General Psychopathology Subscale Score
    -9.2 ( 7.6 )
    -5.1 ( 5.6 )
    -5.9 ( 6.1 )
    -4 ( 4.7 )
    -2.9 ( 4.7 )
    No statistical analyses for this end point

    Secondary: Incidence of clinically significant changes will be calculated for movement disorders, vital signs and routine laboratory tests

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    End point title
    		 Incidence of clinically significant changes will be calculated for movement disorders, vital signs and routine laboratory tests
    End point description
    Includes incidence >2% but <5%
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 PBO-441 mg 441-441 mg PBO-882 mg 882-882 mg De Novo
    Number of subjects analysed
    29
    81
    26
    100
    242
    Units: Subjects
    number (not applicable)
        Akathisia
    1
    0
    2
    3
    12
        Tremor
    1
    0
    0
    4
    7
        Glycosylated haemoglobin increased
    0
    3
    0
    0
    3
        Hypertension
    1
    0
    1
    3
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected at every study visit for 1 year (365 days).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    ALKS 9072, 882 mg
    Reporting group description
    		 ALKS 9072, 882 mg: IM injection, given monthly

    Reporting group title
    ALKS 9072, 441 mg
    Reporting group description
    		 ALKS 9072, 441 mg: IM injection, given monthly

    Serious adverse events
    		 ALKS 9072, 882 mg ALKS 9072, 441 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 368 (4.08%)
    0 / 110 (0.00%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure congestive
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Adenomyosis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 368 (0.54%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Schizophrenia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 368 (0.54%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aggression
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Drug abuse
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depressed mood
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somatoform disorder cardiovascular
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ALKS 9072, 882 mg ALKS 9072, 441 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    59 / 368 (16.03%)
    16 / 110 (14.55%)
    Investigations
    Weight increased
         subjects affected / exposed
    17 / 368 (4.62%)
    7 / 110 (6.36%)
         occurrences all number
    17
    8
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 368 (2.99%)
    7 / 110 (6.36%)
         occurrences all number
    15
    10
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    37 / 368 (10.05%)
    3 / 110 (2.73%)
         occurrences all number
    45
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Nov 2012
    Changed the number of centers to 80; clarified inclusion criterion #1; and added details to the enrollment of subjects who participated in Study ALK9072-003.
    08 Apr 2013
    Added text to Study Drug Section: "ALKS 9072 may be supplied in a vial or in a prefilled syringe."
    08 Oct 2013
    Updated the number of study sites; added text for genotyping of subjects who did not participate in Study ALK9072-003; and added PK sample collection.
    24 Jul 2014
    Objectives to evaluate the rate and cost of hospitalization were added.

    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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