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    Clinical Trial Results:
    Interventional, open-label study of 18 mg Selincro® as needed use, in the treatment of patients with alcohol dependence in primary care

    Summary
    EudraCT number
    		 2013-004688-30
    Trial protocol
    		 GB   DE   ES   IT  
    Global end of trial date
    11 Feb 2016

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

    Trial information

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    Trial identification
    Sponsor protocol code
    15892A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02195817
    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
    11 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the reduction in alcohol consumption in patients with alcohol dependence treated with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial support in primary care (Cohort A).
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH Good Clinical Practice (1996)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Aug 2014
    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
    Spain: 84
    Country: Number of subjects enrolled
    United Kingdom: 97
    Country: Number of subjects enrolled
    France: 43
    Country: Number of subjects enrolled
    Germany: 106
    Worldwide total number of subjects
    330
    EEA total number of subjects
    330
    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)
    285
    From 65 to 84 years
    45
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Cohort A comprised patients who maintained a high drinking risk level (DRL) in the period between the Screening and Inclusion Visits. Cohort B comprised patients who reduced their alcohol consumption (therefore not eligible for Selincro® treatment). No data is reported from the observational cohort (B)

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

    Arms
    Arm title
    		 Cohort A
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nalmefene
    Investigational medicinal product code
    Other name
    Selincro (R)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    18mg; as needed; tablets, orally

    Number of subjects in period 1
    		Cohort A
    Started
    330
    Completed
    268
    Not completed
    62
         Withdrawal of Consent
    21
         Adverse event, non-fatal
    18
         Lost to follow-up
    6
         Non-compliance with IMP
    3
         Administrative or other reason(s)
    7
         Lack of efficacy
    1
         Protocol deviation
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort A
    Reporting group description
    		 -

    Reporting group values
    		 Cohort A Total
    Number of subjects
    		 330 330
    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)
    		 285 285
        From 65-84 years
    		 45 45
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.98 ± 11.25 -
    Gender categorical
    Units: Subjects
        Female
    		 114 114
        Male
    		 216 216
    Race
    Units: Subjects
        White
    		 328 328
        Black Or African American
    		 1 1
        Other
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Cohort A
    Reporting group description
    		 -

    Subject analysis set title
    Baseline
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients who had at least one valid post-inclusion assessment of the primary efficacy variable (HDDs)

    Subject analysis set title
    Month 3
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients at week 12 who had at least one valid post-inclusion assessment of the primary efficacy variable (HDDs)

    Primary: Change in the number of HDDs (days/month)

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    End point title
    		 Change in the number of HDDs (days/month)
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Month 3
    End point values
    		 Baseline Month 3
    Number of subjects analysed
    301
    262
    Units: days/month
        arithmetic mean (standard deviation)
    24.14 ± 5.09
    11.22 ± 10.1
    Statistical analysis title
    		 Change from Baseline to Month 3 in number of HDD
    Statistical analysis description
    Mixed model for repeated measurement, using all available observations until completion or withdrawal from the study. The model included sex, site, and time in months (Months 1 to 3) as fixed categorical effects, baseline number of HDDs as a continuous covariate, and baseline number of HDDs-by-month interaction. An unstructured covariance structure was used to model the within-patient errors and the estimation method used a restricted maximum likelihood (REML)-based approach
    Comparison groups
    Baseline v Month 3
    Number of subjects included in analysis
    563
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.4
         upper limit
    		 -11.9

    Secondary: Change on monthly Total Alcohol Consumption (TAC)

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    End point title
    		 Change on monthly Total Alcohol Consumption (TAC)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Month 3
    End point values
    		 Baseline Month 3
    Number of subjects analysed
    301
    262
    Units: g/day
        arithmetic mean (standard deviation)
    111.23 ± 53.02
    49.55 ± 42.03
    Statistical analysis title
    		 Adjusted Change in Total Alcohol Consumption (TAC)
    Statistical analysis description
    Mixed model for repeated measurement, using all available observations until completion or withdrawal from the study. The model included sex, site, and time in months (Months 1 to 3) as fixed categorical effects, baseline TAC as a continuous covariate, and baseline TAC-by-month interaction. An unstructured covariance structure was used to model the within-patient errors and the estimation method used a restricted maximum likelihood (REML)-based approach
    Comparison groups
    Baseline v Month 3
    Number of subjects included in analysis
    563
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -69.4
         upper limit
    		 -58.6

    Secondary: Response Shift Drinking Risk Level (RSDRL)

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    End point title
    		 Response Shift Drinking Risk Level (RSDRL)
    End point description
    Defined as a downward shift from baseline in drinking risk level (DRL); for patients with a very high DRL at baseline, a shift to medium DRL or lower; for patients with a high DRL at baseline, a shift to low DRL or below
    End point type
    Secondary
    End point timeframe
    Baseline to month 3
    End point values
    		 Cohort A
    Number of subjects analysed
    262
    Units: percentage (%)
        number (confidence interval 95%)
    55.3 (49.3 to 61.2)
    No statistical analyses for this end point

    Secondary: Response Low Drinking Risk Level (RLDRL)

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    End point title
    		 Response Low Drinking Risk Level (RLDRL)
    End point description
    Defined as a downward shift from baseline to Month 3 in DRL; for patients at very high risk at baseline: a shift to medium risk or lower, and for patients at high risk at baseline: a shift to low risk or lower)
    End point type
    Secondary
    End point timeframe
    Baseline and month 3
    End point values
    		 Cohort A
    Number of subjects analysed
    262
    Units: percentage (%)
        number (confidence interval 95%)
    43.9 (38 to 49.9)
    No statistical analyses for this end point

    Secondary: Response defined as ≥70% reduction in TAC

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    End point title
    		 Response defined as ≥70% reduction in TAC
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to Month 3
    End point values
    		 Cohort A
    Number of subjects analysed
    262
    Units: percentage
        number (confidence interval 95%)
    37.4 (31.8 to 43.4)
    No statistical analyses for this end point

    Secondary: Response defined as ≥50% reduction in TAC

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    End point title
    		 Response defined as ≥50% reduction in TAC
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to month 3
    End point values
    		 Cohort A
    Number of subjects analysed
    262
    Units: Percentage
        number (confidence interval 95%)
    61.1 (55 to 66.8)
    No statistical analyses for this end point

    Secondary: Response defined as 0 to 4 HDDs (days/month)

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    End point title
    		 Response defined as 0 to 4 HDDs (days/month)
    End point description
    End point type
    Secondary
    End point timeframe
    Month 3
    End point values
    		 Month 3
    Number of subjects analysed
    262
    Units: percentage
        number (confidence interval 95%)
    37.8 (32.1 to 43.8)
    No statistical analyses for this end point

    Secondary: Change from baseline in Clinical Global Impression, Severity of illness (CGI-S)

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    End point title
    		 Change from baseline in Clinical Global Impression, Severity of illness (CGI-S)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 12
    End point values
    		 Baseline Month 3
    Number of subjects analysed
    301
    265
    Units: Scale
        arithmetic mean (standard deviation)
    4.01 ± 0.95
    2.83 ± 1.08
    Statistical analysis title
    		 Adjusted Change from Baseline to week 12
    Statistical analysis description
    Mixed model for repeated measurement, using all available observations until completion or withdrawal from the study. The model included sex, site, and time in months (Months 1 to 3) as fixed categorical effects, baseline CGI-S as a continuous covariate, and baseline CGI-S-by-month interaction. An unstructured covariance structure was used to model the within-patient errors and the estimation method used a restricted maximum likelihood (REML)-based approach
    Comparison groups
    Baseline v Month 3
    Number of subjects included in analysis
    566
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 -1.1

    Secondary: Clinical Global Impression, global improvement (CGI-I)

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    End point title
    		 Clinical Global Impression, global improvement (CGI-I)
    End point description
    A 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
    End point type
    Secondary
    End point timeframe
    Weeks 12
    End point values
    		 Month 3
    Number of subjects analysed
    265
    Units: score
        arithmetic mean (standard deviation)
    2.51 ± 0.99
    No statistical analyses for this end point

    Secondary: Liver function (γ-glutamyl transferase (γGT))

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    End point title
    		 Liver function (γ-glutamyl transferase (γGT))
    End point description
    Liver function was evaluated by measurement of transaminases, γ-glutamyl transferase (γGT)
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Baseline Month 3
    Number of subjects analysed
    301
    235
    Units: U/L
        geometric mean (standard deviation)
    69.55 ± 153.66
    60.09 ± 176.74
    Statistical analysis title
    		 Change from Baseline in γGT
    Statistical analysis description
    Mixed model for repeated measurement, using all available observations until completion or withdrawal from the study. The model included sex, site, and time in months (Months 1 to 3) as fixed categorical effects, baseline γGT as a continuous covariate, and baseline number of γGT-by-month interaction. An unstructured covariance structure was used to model the within-patient errors and the estimation method used a restricted maximum likelihood (REML)-based approach
    Comparison groups
    Baseline v Month 3
    Number of subjects included in analysis
    536
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Mean
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 0.95

    Secondary: Liver function (alanine aminotransferase (ALT)

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    End point title
    		 Liver function (alanine aminotransferase (ALT)
    End point description
    Liver function was evaluated by measurement of alanine aminotransferase (ALT)
    End point type
    Secondary
    End point timeframe
    week 12
    End point values
    		 Baseline Month 3
    Number of subjects analysed
    301
    231
    Units: IU/L
        geometric mean (standard deviation)
    29.22 ± 23.71
    26.44 ± 20.41
    Statistical analysis title
    		 Change from Baseline in ALT
    Statistical analysis description
    Mixed model for repeated measurement, using all available observations until completion or withdrawal from the study. The model included sex, site, and time in months (Months 1 to 3) as fixed categorical effects, baseline ALT as a continuous covariate, and ALT-by-month interaction. An unstructured covariance structure was used to model the within-patient errors and the estimation method used a restricted maximum likelihood (REML)-based approach
    Comparison groups
    Baseline v Month 3
    Number of subjects included in analysis
    532
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Mean
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 0.97

    Secondary: Liver function (aspartate aminotransferase (AST))

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    End point title
    		 Liver function (aspartate aminotransferase (AST))
    End point description
    End point type
    Secondary
    End point timeframe
    week 12
    End point values
    		 Baseline Month 3
    Number of subjects analysed
    300
    231
    Units: U/L
        geometric mean (standard deviation)
    32.17 ± 32.32
    28.52 ± 33.46
    Statistical analysis title
    		 Analysis of Change from Baseline in AST
    Statistical analysis description
    Mixed model for repeated measurement, using all available observations until completion or withdrawal from the study. The model included sex, site, and time in months (Months 1 to 3) as fixed categorical effects, baseline AST as a continuous covariate, and baseline AST-by-month interaction. An unstructured covariance structure was used to model the within-patient errors and the estimation method used a restricted maximum likelihood (REML)-based approach
    Comparison groups
    Baseline v Month 3
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Mean
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 0.95

    Secondary: Change in the Short-Form 36-Item Health Survey (SF-36): physical

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    End point title
    		 Change in the Short-Form 36-Item Health Survey (SF-36): physical
    End point description
    The scores range from 0 to 100, with higher scores indicating better quality of life
    End point type
    Secondary
    End point timeframe
    baseline to week 12
    End point values
    		 Baseline Month 3
    Number of subjects analysed
    123
    123
    Units: Scale
        arithmetic mean (standard deviation)
    44.9 ± 9.83
    46.94 ± 9.79
    Statistical analysis title
    		 Change from Baseline in SF-36 Physical Component
    Statistical analysis description
    Analysed using an ANCOVA model with missing values imputed by last observation carried forward (LOCF), including sex and site as fixed effects, and baseline score as a covariate
    Comparison groups
    Baseline v Month 3
    Number of subjects included in analysis
    246
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 3.9

    Secondary: Change in the Short-Form 36-Item Health Survey (SF-36): Mental component

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    End point title
    		 Change in the Short-Form 36-Item Health Survey (SF-36): Mental component
    End point description
    The scores range from 0 to 100, with higher scores indicating better quality of life
    End point type
    Secondary
    End point timeframe
    baseline to week 12
    End point values
    		 Baseline Month 3
    Number of subjects analysed
    123
    123
    Units: Scale
        arithmetic mean (standard deviation)
    31.76 ± 13.15
    38.98 ± 14.28
    Statistical analysis title
    		 Change from Baseline in SF-36 Mentall Component
    Statistical analysis description
    Analysed using an ANCOVA model with missing values imputed by last observation carried forward (LOCF), including sex and site as fixed effects, and baseline score as a covariate
    Comparison groups
    Baseline v Month 3
    Number of subjects included in analysis
    246
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.9
         upper limit
    		 10.5

    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
    18.1
    Reporting groups
    Reporting group title
    COHORT A
    Reporting group description
    		 COHORT A

    Serious adverse events
    		 COHORT A
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 311 (7.07%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Coronary artery stenosis
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Presyncope
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatic cirrhosis
         subjects affected / exposed
    2 / 311 (0.64%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    1 / 1
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    2 / 311 (0.64%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Delirium tremens
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Depressive symptom
         subjects affected / exposed
    2 / 311 (0.64%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Flight of ideas
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Impulsive behaviour
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mood swings
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 COHORT A
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    118 / 311 (37.94%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    55 / 311 (17.68%)
         occurrences all number
    71
    Headache
         subjects affected / exposed
    24 / 311 (7.72%)
         occurrences all number
    27
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    57 / 311 (18.33%)
         occurrences all number
    66
    Vomiting
         subjects affected / exposed
    19 / 311 (6.11%)
         occurrences all number
    23
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    33 / 311 (10.61%)
         occurrences all number
    37

    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? Yes
    Date
    Interruption
    Restart date
    25 Sep 2015
    The study was terminated due to enrolment challenges
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated due to enrolment challenges
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