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    Clinical Trial Results:
    Long-Term Safety and Efficacy of ABT-126 in Subjects with Schizophrenia: A Double-Blind Extension Study for Subjects Completing Study M10-855

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2012-005661-13
    Trial protocol
    		 GB  
    Global end of trial date
    03 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jul 2016
    First version publication date
    24 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M13-765
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01834638
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Abbvie Deutschland GmbH & Co.KG
    Sponsor organisation address
    Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    Global Medical Services, AbbVie, 001 800-633-9110,
    Scientific contact
    George Haig, AbbVie, george.haig@abbvie.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 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Dec 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of this study is to obtain long-term safety, efficacy and health outcomes data in patients with schizophrenia.
    Protection of trial subjects
    Subject and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    		 Subjects remained on their baseline antipsychotic treatment regimen during the entire study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Mar 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Russian Federation: 147
    Country: Number of subjects enrolled
    United States: 114
    Worldwide total number of subjects
    267
    EEA total number of subjects
    6
    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)
    265
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Stable nonsmoking male and female subjects with a diagnosis of schizophrenia who were receiving one or more allowed antipsychotic medications and who completed Study M10-855 (EudraCT number 2012-005661-13) and met all inclusion criteria and none of the exclusion criteria were enrolled into the study.

    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
    Blinding implementation details
    All subjects received ABT-126, but the investigator and the subject were blinded to the actual dose of ABT-126 in order to maintain the study blind from base Study M10-855.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ABT-126 25 mg QD
    Arm description
    		 1 ABT-126 25 mg capsule and 2 placebo capsules taken orally once daily (QD) in the morning each day for 52 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-126
    Investigational medicinal product code
    ABT-126
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were instructed to take 3 capsules at approximately the same time each morning.

    Arm title
    		 ABT-126 50 mg QD
    Arm description
    		 2 ABT-126 25 mg capsules and 1 placebo capsule taken orally QD in the morning each day for 52 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-126
    Investigational medicinal product code
    ABT-126
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were instructed to take 3 capsules at approximately the same time each morning.

    Arm title
    		 ABT-126 75 mg QD
    Arm description
    		 3 ABT-126 25 mg capsules taken orally QD in the morning each day for 52 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-126
    Investigational medicinal product code
    ABT-126
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were instructed to take 3 capsules at approximately the same time each morning.

    Number of subjects in period 1
    		ABT-126 25 mg QD ABT-126 50 mg QD ABT-126 75 mg QD
    Started
    47
    172
    48
    Completed
    10
    11
    8
    Not completed
    37
    161
    40
         Consent withdrawn by subject
    7
    10
    6
         Not specified
    27
    147
    31
         Adverse event
    1
    1
    -
         Lost to follow-up
    -
    3
    2
         Noncompliance
    2
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABT-126 25 mg QD
    Reporting group description
    		 1 ABT-126 25 mg capsule and 2 placebo capsules taken orally once daily (QD) in the morning each day for 52 weeks

    Reporting group title
    ABT-126 50 mg QD
    Reporting group description
    		 2 ABT-126 25 mg capsules and 1 placebo capsule taken orally QD in the morning each day for 52 weeks

    Reporting group title
    ABT-126 75 mg QD
    Reporting group description
    		 3 ABT-126 25 mg capsules taken orally QD in the morning each day for 52 weeks

    Reporting group values
    		 ABT-126 25 mg QD ABT-126 50 mg QD ABT-126 75 mg QD Total
    Number of subjects
    		 47 172 48 267
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.1 ± 10.26 41.6 ± 11.91 40.8 ± 10.9 -
    Gender categorical
    Units: Subjects
        Female
    		 26 84 25 135
        Male
    		 21 88 23 132

    End points

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    End points reporting groups
    Reporting group title
    ABT-126 25 mg QD
    Reporting group description
    		 1 ABT-126 25 mg capsule and 2 placebo capsules taken orally once daily (QD) in the morning each day for 52 weeks

    Reporting group title
    ABT-126 50 mg QD
    Reporting group description
    		 2 ABT-126 25 mg capsules and 1 placebo capsule taken orally QD in the morning each day for 52 weeks

    Reporting group title
    ABT-126 75 mg QD
    Reporting group description
    		 3 ABT-126 25 mg capsules taken orally QD in the morning each day for 52 weeks

    Subject analysis set title
    ABT-126 Total
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    1, 2, or 3 ABT-126 25 mg capsules (25 mg, 50 mg, or 75 mg ABT-126) taken orally QD in the morning each day for 52 weeks

    Primary: Number of Subjects with Treatment-emergent Adverse Events (AEs) or Serious AEs (SAEs)

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    End point title
    		 Number of Subjects with Treatment-emergent Adverse Events (AEs) or Serious AEs (SAEs) [1]
    End point description
    AE: any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. SAE: an AE that meets any of the following criteria: results in death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome. All AEs presented were treatment-emergent unless otherwise noted. Treatment-emergent AEs were defined as those that began or worsened in severity on or after the first dose of study drug in Study M13-765 and no more than 30 days after the last dose of study drug.
    End point type
    Primary
    End point timeframe
    up to 52 weeks (+ 30 days)
    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: Descriptive statistics were planned and are presented for this safety endpoint.
    End point values
    		 ABT-126 25 mg QD ABT-126 50 mg QD ABT-126 75 mg QD ABT-126 Total
    Number of subjects analysed
    47
    172
    48
    267
    Units: subjects
        Any AE
    22
    57
    21
    100
        AE w/reasonable possibility of drug relatedness
    5
    14
    6
    25
        Any severe AE
    2
    3
    0
    5
        Any SAE
    3
    3
    0
    6
        Any AE leading to discontinuation of study drug
    3
    2
    0
    5
        Any fatal AE
    0
    0
    0
    0
        Deaths (all deaths during the study)
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects with Potentially Clinically Significant Hematology Values

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    End point title
    		 Number of Subjects with Potentially Clinically Significant Hematology Values [2]
    End point description
    F=female; M=male
    End point type
    Primary
    End point timeframe
    up to 52 weeks
    Notes
    [2] - 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: Descriptive statistics were planned and are presented for this safety endpoint.
    End point values
    		 ABT-126 25 mg QD ABT-126 50 mg QD ABT-126 75 mg QD ABT-126 Total
    Number of subjects analysed
    47
    170 [3]
    46 [4]
    263 [5]
    Units: subjects
        Hemoglobin: <90 G/L (F); <100 G/L (M)
    1
    1
    0
    2
        Hemoglobin: >180 G/L (F); >180 G/L (M)
    0
    1
    1
    2
        Hematocrit: <0.34 fraction (F); <0.35 fraction (M)
    2
    11
    3
    16
        Hematocrit: >0.55 fraction (F); >0.55 fraction (M)
    0
    3
    0
    3
        White Blood Cell Count: <2.8*10^9/L
    0
    3
    0
    3
        Neutrophils: <1.2*10^9/L
    1
    4
    0
    5
        Lymphocytes: <0.75*10^9/L
    1
    1
    0
    2
    Notes
    [3] - subjects with an assessment
    [4] - subjects with an assessment
    [5] - subjects with an assessment
    No statistical analyses for this end point

    Primary: Number of Subjects with Potentially Clinically Significant Chemistry Values

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    End point title
    		 Number of Subjects with Potentially Clinically Significant Chemistry Values [6]
    End point description
    ULN=upper limit of normal
    End point type
    Primary
    End point timeframe
    up to 52 weeks
    Notes
    [6] - 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: Descriptive statistics were planned and are presented for this safety endpoint.
    End point values
    		 ABT-126 25 mg QD ABT-126 50 mg QD ABT-126 75 mg QD ABT-126 Total
    Number of subjects analysed
    47
    172
    46 [7]
    265 [8]
    Units: subjects
        Alanine aminotransferase >3*ULN
    0
    3
    0
    3
        Total bilirubin >29 mcmol/L
    1
    2
    2
    5
        Creatine phosphokinase >1950 U/L
    0
    1
    0
    1
        Potassium >6 mmol/L
    1
    0
    0
    1
        Glucose <2.5 mmol/L
    0
    0
    1
    1
        Clucose >16.7 mmol/L
    0
    1
    0
    1
    Notes
    [7] - all subjects with an assessment
    [8] - subjects with an assessment
    No statistical analyses for this end point

    Primary: Number of Subjects with AEs Related to Abnormal Urinalysis Parameters

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    End point title
    		 Number of Subjects with AEs Related to Abnormal Urinalysis Parameters [9]
    End point description
    End point type
    Primary
    End point timeframe
    up to 52 weeks
    Notes
    [9] - 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: Descriptive statistics were planned and are presented for this safety endpoint.
    End point values
    		 ABT-126 25 mg QD ABT-126 50 mg QD ABT-126 75 mg QD ABT-126 Total
    Number of subjects analysed
    47
    172
    48
    267
    Units: subjects
    0
    0
    1
    1
    No statistical analyses for this end point

    Primary: Number of Subjects with Potentially Clinically Significant Electrocardiogram (ECG) Values

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    End point title
    		 Number of Subjects with Potentially Clinically Significant Electrocardiogram (ECG) Values [10]
    End point description
    End point type
    Primary
    End point timeframe
    up to 52 weeks
    Notes
    [10] - 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: Descriptive statistics were planned and are presented for this safety endpoint.
    End point values
    		 ABT-126 25 mg QD ABT-126 50 mg QD ABT-126 75 mg QD ABT-126 Total
    Number of subjects analysed
    47
    172
    46 [11]
    265 [12]
    Units: subjects
        Bazett QTC interval >480 msec
    1
    2
    1
    4
        Bazett QTC interval >60 msec increase
    0
    1
    0
    1
        Fridericia QTC interval >480 msec
    0
    0
    0
    0
        Fridericia QTC interval >60 msec increase
    0
    0
    0
    0
    Notes
    [11] - subjects with an assessment
    [12] - subjects with an assessment
    No statistical analyses for this end point

    Primary: Number of Subjects with AEs Related to Physical Examinations

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    End point title
    		 Number of Subjects with AEs Related to Physical Examinations [13]
    End point description
    End point type
    Primary
    End point timeframe
    up to 52 weeks
    Notes
    [13] - 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: Descriptive statistics were planned and are presented for this safety endpoint.
    End point values
    		 ABT-126 25 mg QD ABT-126 50 mg QD ABT-126 75 mg QD ABT-126 Total
    Number of subjects analysed
    47
    172
    48
    267
    Units: subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Summary of Columbia-Suicide Severity Rating Scale (C-SSRS) Responses Through Study Follow-up

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    End point title
    		 Summary of Columbia-Suicide Severity Rating Scale (C-SSRS) Responses Through Study Follow-up [14]
    End point description
    The C-SSRS is a systematically administered instrument developed to track suicidal AEs across a treatment study. The instrument is designed to assess suicidal behavior and ideation and track and assess all suicidal events, as well as the lethality of attempts. The C-SSRS was conducted at all visits to assess suicidal ideation and behavior as well as other events related to suicidality. NS=non-specific; AT=active thoughts; SI=suicidal ideations; DS=during study; SB=suicidal behaviours.
    End point type
    Primary
    End point timeframe
    Collected at Weeks 2, 4, 8, 12, 18, 26, 32, 38, 44, 52
    Notes
    [14] - 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: Descriptive statistics were planned and are presented for this safety endpoint.
    End point values
    		 ABT-126 25 mg QD ABT-126 50 mg QD ABT-126 75 mg QD ABT-126 Total
    Number of subjects analysed
    47 [15]
    171 [16]
    46 [17]
    264 [18]
    Units: subjects
        Week (Wk) 2: Wish to be dead; n=47, 171, 46, 264
    0
    1
    0
    1
        Wk 2:NS active suicidal thoughts;n=47, 171, 46,264
    0
    0
    0
    0
        Wk 2: AT without intent to act; n=47, 171, 46, 264
    0
    0
    0
    0
        Wk 2: AT with some intent no plan;n=47,171,46,264
    0
    0
    0
    0
        Wk 2: AT with plan and intent; n=47, 171, 46, 264
    0
    0
    0
    0
        Week 2: Actual attempt; n=47, 171, 46, 264
    0
    0
    0
    0
        Week 2: Interrupted attempt; n=47, 171, 46, 264
    0
    0
    0
    0
        Week 2: Aborted attempt; n=47, 171, 46, 264
    0
    0
    0
    0
        Wk 2: Preparatory acts/behaviour; n=47,171,46,264
    0
    0
    0
    0
        Week 2: Suicidal behaviour; n=47, 171, 46, 264
    0
    0
    0
    0
        Week 2: Completed suicide; n=47, 171, 46, 264
    0
    0
    0
    0
        Week 2: Subjects with SI; n=47, 171, 46, 264
    0
    1
    0
    1
        Week 2: Subjects with SI only; n=47, 171, 46, 264
    0
    1
    0
    1
        Week 4: Wish to be dead; n=47, 171, 46, 264
    0
    1
    0
    1
        Wk 4: NS active suicidal thoughts;n=47,171,46, 264
    0
    0
    0
    0
        Wk 4: AT without intent to act; n=47, 171, 46, 264
    0
    0
    0
    0
        Wk 4: AT with some intent no plan;n=47,171,46,264
    0
    0
    0
    0
        Wk 4: AT with plan and intent; n=47, 171, 46, 264
    0
    0
    0
    0
        Week 4: Actual attempt; n=47, 171, 46, 264
    1
    0
    1
    2
        Week 4: Interrupted attempt; n=47, 171, 46, 264
    0
    0
    0
    0
        Week 4: Aborted attempt; n=47, 171, 46, 264
    0
    0
    0
    0
        Wk 4: Preparatory acts/behaviour; n=47,171,46,264
    0
    0
    0
    0
        Week 4: Suicidal behaviour; n=47, 171, 46, 264
    0
    0
    0
    0
        Week 4: Completed suicide; n=47, 171, 46, 264
    0
    0
    0
    0
        Week 4: Subjects with SI; n=47, 171, 46, 264
    0
    1
    0
    1
        Week 4: Subjects with SI only; n=47, 171, 46, 264
    0
    1
    0
    1
        Week 8: Wish to be dead; n=45, 168, 46, 259
    0
    2
    0
    2
        Wk 8: NS active suicidal thoughts;n=45,168,46,259
    0
    0
    0
    0
        Wk 8: AT without intent to act;n=45, 168, 46, 259
    0
    0
    0
    0
        Wk 8: AT with some intent no plan; n=45,168,46,259
    0
    0
    0
    0
        Wk 8: AT with plan and intent; n=45, 168, 46, 259
    0
    0
    0
    0
        Week 8: Actual attempt; n=45, 168, 46, 259
    0
    2
    0
    2
        Week 8: Interrupted attempt; n=45, 168, 46, 259
    0
    0
    0
    0
        Week 8: Aborted attempt; n=45, 168, 46, 259
    0
    0
    0
    0
        Wk 8: Preparatory acts/behaviour; n=45,168,46,259
    0
    0
    0
    0
        Week 8: Suicidal behaviour; n=45, 168, 46, 259
    0
    0
    0
    0
        Week 8: Completed suicide; n=45, 168, 46, 259
    0
    0
    0
    0
        Week 8: Subjects with SI; n=45, 168, 46, 259
    0
    2
    0
    2
        Week 8: Subjects with SI only; n=45, 168, 46, 259
    0
    2
    0
    2
        Week 12: Wish to be dead; n=44, 163, 46, 253
    0
    0
    1
    1
        Wk 12:NS active suicidal thoughts;n=44,163,46,253
    0
    0
    0
    0
        Wk 12: AT without intent to act; n=44,163,46,253
    0
    0
    0
    0
        Wk 12: AT with some intent no plan;n=44,163,46,253
    0
    0
    0
    0
        Wk 12: AT with plan and intent; n=44, 163, 46, 253
    0
    0
    0
    0
        Week 12: Actual attempt; n=44, 163, 46, 253
    0
    1
    0
    1
        Week 12: Interrupted attempt; n=44, 163, 46, 253
    0
    0
    0
    0
        Week 12: Aborted attempt; n=44, 163, 46, 253
    0
    0
    0
    0
        Wk 12: Preparatory acts/behaviour; n=44,163,46,253
    0
    0
    0
    0
        Week 12: Suicidal behaviour; n=44, 163, 46, 253
    0
    0
    0
    0
        Week 12: Completed suicide; n=44, 163, 46, 253
    0
    0
    0
    0
        Week 12: Subjects with SI; n=44, 163, 46, 253
    0
    0
    1
    1
        Week 12: Subjects with SI only; n=44, 163, 46, 253
    0
    0
    1
    1
        Week 18: Wish to be dead; n=43, 130, 44, 217
    0
    1
    0
    1
        Wk 18: NS active suicidal thoughts;n=43,130,44,217
    0
    0
    0
    0
        Wk 18: AT without intent to act;n=43, 130, 44, 217
    0
    0
    0
    0
        Wk 18: AT with some intent no plan;n=43,130,44,217
    0
    0
    0
    0
        Wk 18: AT with plan and intent; n=43, 130, 44, 217
    0
    0
    0
    0
        Week 18: Actual attempt; n=43, 130, 44, 217
    0
    0
    0
    0
        Week 18: Interrupted attempt; n=43, 130, 44, 217
    0
    0
    0
    0
        Week 18: Aborted attempt; n=43, 130, 44, 217
    0
    0
    0
    0
        Wk 18: Preparatory acts/behaviour;n=43,130,44,217
    0
    0
    0
    0
        Week 18: Suicidal behaviour; n=43, 130, 44, 217
    0
    0
    0
    0
        Week 18: Completed suicide; n=43, 130, 44, 217
    0
    0
    0
    0
        Week 18: Subjects with SI; n=43, 130, 44, 217
    0
    1
    0
    1
        Week 18: Subjects with SI only; n=43, 130, 44, 217
    0
    1
    0
    1
        Week 26: Wish to be dead; n=42, 101, 41, 184
    1
    1
    1
    3
        Wk 26: NS active suicidal thoughts;n=42, 101, 184
    1
    0
    0
    1
        Wk 26: AT without intent to act; n=42,101,41,184
    1
    0
    0
    1
        Wk 26: AT with some intent no plan;n=42,101,41,184
    1
    0
    0
    1
        Wk 26: AT with plan and intent; n=42, 101, 41, 184
    1
    0
    0
    1
        Week 26: Actual attempt; n=42, 101, 41, 184
    0
    1
    0
    1
        Week 26: Interrupted attempt; n=42, 101, 41, 184
    0
    0
    0
    0
        Week 26: Aborted attempt; n=42, 101, 41, 184
    0
    0
    0
    0
        Wk 26: Preparatory acts/behaviour;n=42,101,41,184
    0
    0
    0
    0
        Week 26: Suicidal behaviour; n=42, 101, 41, 184
    1
    0
    0
    1
        Week 26: Completed suicide; n=42, 101, 41, 184
    0
    0
    0
    0
        Week 26: Subjects with SI; n=42, 101, 41, 184
    1
    1
    1
    3
        Week 26: Subjects with SI only; n=42, 101, 41, 184
    0
    1
    1
    2
        Week 32: Wish to be dead; n=40, 60, 38, 138
    1
    0
    0
    1
        Wk 32: NS active suicidal thoughts; n=40,60,38,138
    1
    0
    0
    1
        Wk 32: AT without intent to act; n=40, 60, 38, 138
    1
    0
    0
    1
        Wk 32: AT with some intent no plan; n=40,60,38,138
    1
    0
    0
    1
        Wk 32: AT with plan and intent; n=40, 60, 38, 138
    1
    0
    0
    1
        Week 32: Actual attempt; n=40, 60, 38, 138
    0
    1
    1
    2
        Week 32: Interrupted attempt; n=40, 60, 38, 138
    0
    0
    0
    0
        Week 32: Aborted attempt; n=40, 60, 38, 138
    0
    0
    0
    0
        Wk 32: Preparatory acts/behaviour; n=40,60,38,138
    0
    0
    0
    0
        Week 32: Suicidal behaviour; n=40, 60, 38, 138
    1
    0
    0
    1
        Week 32: Completed suicide; n=40, 60, 38, 138
    0
    0
    0
    0
        Week 32: Subjects with SI; n=40, 60, 38, 138
    1
    0
    0
    1
        Week 32: Subjects with SI only; n=40, 60, 38, 138
    0
    0
    0
    0
        Week 38: Wish to be dead; n=33, 44, 32, 109
    0
    0
    0
    0
        Wk 38: NS active suicidal thoughts; n=33,44,32,109
    0
    0
    0
    0
        Wk 38: AT without intent to act; n=33, 44, 32, 109
    0
    0
    0
    0
        Wk 38: AT with some intent no plan; n=33,44,32,109
    0
    0
    0
    0
        Wk 38: AT with plan and intent; n=33, 44, 32, 109
    0
    0
    0
    0
        Week 38: Actual attempt; n=33, 44, 32, 109
    0
    0
    0
    0
        Week 38: Interrupted attempt; n=33, 44, 32, 109
    0
    0
    0
    0
        Week 38: Aborted attempt; n=33, 44, 32, 109
    0
    0
    0
    0
        Wk 38: Preparatory acts/behaviour; n=33,44,32,109
    0
    0
    0
    0
        Week 38: Suicidal behaviour; n=33, 44, 32, 109
    0
    0
    0
    0
        Week 38: Completed suicide; n=33, 44, 32, 109
    0
    0
    0
    0
        Week 38: Subjects with SI; n=33, 44, 32, 109
    0
    0
    0
    0
        Week 38: Subjects with SI only; n=33, 44, 32, 109
    0
    0
    0
    0
        Week 44: Wish to be dead; n=25, 29, 24, 78
    0
    0
    0
    0
        Wk 44: NS active suicidal thoughts; n=25,29,24,78
    0
    0
    0
    0
        Wk 44: AT without intent to act; n=25, 29, 24, 78
    0
    0
    0
    0
        Wk 44: AT with some intent no plan; n=25,29,24,78
    0
    0
    0
    0
        Week 44: AT with plan and intent; n=25, 29, 24, 78
    0
    0
    0
    0
        Week 44: Actual attempt; n=25, 29, 24, 78
    1
    0
    0
    1
        Week 44: Interrupted attempt; n=25, 29, 24, 78
    0
    0
    0
    0
        Week 44: Aborted attempt; n=25, 29, 24, 78
    0
    0
    0
    0
        Wk 44: Preparatory acts/behaviour; n=25,29,24,78
    0
    0
    0
    0
        Week 44: Suicidal behaviour; n=25, 29, 24, 78
    0
    0
    0
    0
        Week 44: Completed suicide; n=25, 29, 24, 78
    0
    0
    0
    0
        Week 44: Subjects with SI; n=25, 29, 24, 78
    0
    0
    0
    0
        Week 44: Subjects with SI only; n=25, 29, 24, 78
    0
    0
    0
    0
        Week 52: Wish to be dead; n=17, 17, 16, 50
    0
    0
    1
    1
        Wk 52: NS active suicidal thoughts; n=17,17,16,50
    0
    0
    0
    0
        Wk 52: AT without intent to act; n=17, 17, 16, 50
    0
    0
    0
    0
        Wk 52: AT with some intent no plan; n=17,17,16,50
    0
    0
    0
    0
        Week 52: AT with plan and intent; n=17, 17, 16, 50
    0
    0
    0
    0
        Week 52: Actual attempt; n=17, 17, 16, 50
    1
    0
    0
    1
        Week 52: Interrupted attempt; n=17, 17, 16, 50
    0
    0
    0
    0
        Week 52: Aborted attempt; n=17, 17, 16, 50
    0
    0
    0
    0
        Wk 52: Preparatory acts/behaviour; n=17,17,16,50
    0
    0
    0
    0
        Week 52: Suicidal behaviour; n=17, 17, 16, 50
    0
    0
    0
    0
        Week 52: Completed suicide; n=17, 17, 16, 50
    0
    0
    0
    0
        Week 52: Subjects with SI; n=17, 17, 16, 50
    0
    0
    1
    1
        Week 52: Subjects with SI only; n=17, 17, 16, 50
    0
    0
    1
    1
        Follow-up: Wish to be dead; n=6, 4, 3, 13
    1
    0
    0
    1
        Follow-up: NS active suicidal thoughts; n=6,4,3,13
    0
    0
    0
    0
        Follow-up: AT without intent to act; n=6,4,3,13
    0
    0
    0
    0
        Follow-up: AT with some intent no plan; n=6,4,3,13
    0
    0
    0
    0
        Follow-up: AT with plan and intent; n=6, 4, 3, 13
    0
    0
    0
    0
        Follow-up: Actual attempt; n=6, 4, 3, 13
    1
    0
    0
    1
        Follow-up: Interrupted attempt; n=6, 4, 3, 13
    0
    0
    0
    0
        Follow-up: Aborted attempt; n=6, 4, 3, 13
    0
    0
    0
    0
        Follow-up: Preparatory acts/behaviour; n=6,4,3,13
    0
    0
    0
    0
        Follow-up: Suicidal behaviour; n=6, 4, 3, 13
    0
    0
    0
    0
        Follow-up: Completed suicide; n=6, 4, 3, 13
    0
    0
    0
    0
        Follow-up: Subjects with SI; n=6, 4, 3, 13
    1
    0
    0
    1
        Follow-up: Subjects with SI only; n=6, 4, 3, 13
    0
    0
    0
    0
        DS: Wish to be dead; n=47, 172, 48, 267
    3
    2
    1
    6
        DS: NS active suicidal thoughts;n=47, 172, 48, 267
    2
    0
    0
    2
        DS: AT without intent to act;n=47, 172, 48, 267
    2
    0
    0
    2
        DS: AT with some intent no plan;n=47, 172, 48, 267
    2
    0
    0
    2
        DS: AT with plan and intent; n=47, 172, 48, 267
    2
    0
    0
    2
        DS: Actual attempt; n=47, 172, 48, 267
    4
    4
    2
    10
        DS: Interrupted attempt; n=47, 172, 48, 267
    0
    0
    0
    0
        DS: Aborted attempt; n=47, 172, 48, 267
    0
    0
    0
    0
        DS: Preparatory acts/behaviour; n=47, 172, 48, 267
    0
    0
    0
    0
        DS: Suicidal behaviour; n=47, 172, 48, 267
    2
    0
    0
    2
        DS: Completed suicide; n=47, 172, 48, 267
    0
    0
    0
    0
        DS: Subjects with SI; n=47, 172, 48, 267
    3
    2
    1
    6
        DS: Subjects with SI only; n=47, 172, 48, 267
    0
    2
    1
    3
        DS: Subjects with SB; n=47, 172, 48, 267
    6
    4
    2
    12
        DS: Subjects with SB or SI; n=47, 172, 48, 267
    6
    6
    3
    15
    Notes
    [15] - subjects with an assessment; n=subjects with an assessment at given timepoint
    [16] - subjects with an assessment; n=subjects with an assessment at given timepoint
    [17] - subjects with an assessment; n=subjects with an assessment at given timepoint
    [18] - subjects with an assessment; n=subjects with an assessment at given timepoint
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were reported from the time of study drug administration (Day 1) until 30 days following discontinuation of study drug administration have elapsed were collected. Total study duration was up to 52 weeks.
    Adverse event reporting additional description
    All AEs presented in this section were treatment-emergent unless otherwise noted. Treatment-emergent AEs were defined as those that began or worsened in severity on or after the first dose of study drug in Study M13-765 and no more than 30 days after the last dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    ABT-126 25 mg QD
    Reporting group description
    		 1 ABT-126 25 mg capsule and 2 placebo capsules taken orally QD in the morning each day for 52 weeks

    Reporting group title
    ABT-126 50 mg QD
    Reporting group description
    		 2 ABT-126 25 mg capsules and 1 placebo capsule taken orally QD in the morning each day for 52 weeks

    Reporting group title
    ABT-126 75 mg QD
    Reporting group description
    		 3 ABT-126 25 mg capsules taken orally QD in the morning each day for 52 weeks

    Reporting group title
    ABT-126 Total
    Reporting group description
    		 1, 2, or 3 ABT-126 25 mg capsules taken orally QD in the morning each day for 52 weeks

    Serious adverse events
    		 ABT-126 25 mg QD ABT-126 50 mg QD ABT-126 75 mg QD ABT-126 Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 47 (6.38%)
    3 / 172 (1.74%)
    0 / 48 (0.00%)
    6 / 267 (2.25%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 172 (0.58%)
    0 / 48 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Intentional overdose
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 172 (0.00%)
    0 / 48 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 172 (0.58%)
    0 / 48 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 172 (0.58%)
    0 / 48 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 172 (0.00%)
    0 / 48 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Self injurious behaviour
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 172 (0.00%)
    0 / 48 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 172 (0.00%)
    0 / 48 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 172 (0.58%)
    0 / 48 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 172 (0.58%)
    0 / 48 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ABT-126 25 mg QD ABT-126 50 mg QD ABT-126 75 mg QD ABT-126 Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 47 (17.02%)
    9 / 172 (5.23%)
    11 / 48 (22.92%)
    28 / 267 (10.49%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 47 (4.26%)
    6 / 172 (3.49%)
    5 / 48 (10.42%)
    13 / 267 (4.87%)
         occurrences all number
    3
    9
    7
    19
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 47 (8.51%)
    2 / 172 (1.16%)
    2 / 48 (4.17%)
    8 / 267 (3.00%)
         occurrences all number
    4
    2
    4
    10
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 172 (0.58%)
    3 / 48 (6.25%)
    4 / 267 (1.50%)
         occurrences all number
    0
    1
    4
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 47 (8.51%)
    3 / 172 (1.74%)
    3 / 48 (6.25%)
    10 / 267 (3.75%)
         occurrences all number
    4
    4
    3
    11

    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.
    This study was terminated early due to insufficient efficacy of ABT-126 for treatment of cognitive impairment associated with schizophrenia in the double-blind Phase 2 Studies M10-855 and M13-608 to support further clinical development.
    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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