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    Clinical Trial Results:
    Baclofen for the Treatment of Alcohol Dependence

    Summary
    EudraCT number
    		 2010-021861-62
    Trial protocol
    		 DE  
    Global end of trial date
    20 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2022
    First version publication date
    18 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BACLAD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01266655
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité - Universitätsmedizin Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany,
    Public contact
    Department of Psychiatry, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Germany, Department of Psychiatry, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Germany, +49 30-450-517002, chefsek-psychiatrie-ccm@charite.de
    Scientific contact
    Department of Psychiatry, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Germany, Department of Psychiatry, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Germany, +49 30-450-517002, chefsek-psychiatrie-ccm@charite.de
    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
    13 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    20 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy and safety of individually titrated high-dose baclofen (up to 270 mg/d) in alcohol-dependent patients in a double-blind, randomized and placebo-controlled trial. Multiple primary outcome measures: (1) total abstinence and (2) cumulative abstinence duration during the high-dose phase.
    Protection of trial subjects
    The trial was conducted in conformance with Good Clinical Practice (GCP) standards and applicable local statutes and regulations regarding ethical committee review, informed consent and the protection of human subjects participating in biomedical research. The following additional measures, defined for this individual trial, were in-place for the protection of the trial subjects: 13 to 17 visits throughout the study (depending on the individually titrated high-dose). Additionally, telephone visits were performed during the titration and tapering phases after each dosing step.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Mar 2011
    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
    Germany: 56
    Worldwide total number of subjects
    56
    EEA total number of subjects
    56
    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)
    56
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at the outpatient unit of the Department of Psychiatry and Psychotherapy at Charité - Universitätsmedizin Berlin between March 2011 and May 2014.

    Pre-assignment
    Screening details
    		 A total of 93 alcohol-dependent subjects entered the screening period.

    Period 1
    Period 1 title
    overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo (30-270 mg/d) for up to 20 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received placebo 5-90 mg t.i.d.

    Arm title
    		 Baclofen
    Arm description
    		 Subjects received baclofen (30-270 mg/d) for up to 20 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baclofen
    Investigational medicinal product code
    1134-47-0
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received baclofen 5 to 90 mg t.i.d.

    Number of subjects in period 1
    		Placebo Baclofen
    Started
    28
    28
    Completed
    4
    12
    Not completed
    24
    16
         Relapse
    18
    10
         Participant choice
    3
    1
         Protocol violation
    1
    -
         Adverse event, non-fatal
    -
    2
         Lost to follow-up
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo (30-270 mg/d) for up to 20 weeks.

    Reporting group title
    Baclofen
    Reporting group description
    		 Subjects received baclofen (30-270 mg/d) for up to 20 weeks.

    Reporting group values
    		 Placebo Baclofen Total
    Number of subjects
    		 28 28 56
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.6 ± 7 47.4 ± 7 -
    Gender categorical
    Units: Subjects
        Female
    		 9 8 17
        Male
    		 19 20 39

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo (30-270 mg/d) for up to 20 weeks.

    Reporting group title
    Baclofen
    Reporting group description
    		 Subjects received baclofen (30-270 mg/d) for up to 20 weeks.

    Primary: Total abstinence during the high-dose phase

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    End point title
    		 Total abstinence during the high-dose phase
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks.
    End point values
    		 Placebo Baclofen
    Number of subjects analysed
    28
    28
    Units: number of patients
    5
    15
    Statistical analysis title
    		 Non-parametric exact Wilcoxon-Mann-Whitney test
    Comparison groups
    Baclofen v Placebo
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 weeks.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 own
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Baclofen
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Baclofen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Baclofen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 28 (100.00%)
    28 / 28 (100.00%)
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    2 / 28 (7.14%)
    3 / 28 (10.71%)
         occurrences all number
    2
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 28 (25.00%)
    4 / 28 (14.29%)
         occurrences all number
    7
    4
    Tingling sensation
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 28 (10.71%)
         occurrences all number
    0
    3
    Pain diverse
         subjects affected / exposed
    8 / 28 (28.57%)
    4 / 28 (14.29%)
         occurrences all number
    8
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    7 / 28 (25.00%)
    13 / 28 (46.43%)
         occurrences all number
    7
    13
    Ear and labyrinth disorders
    Vertigo/dizziness
         subjects affected / exposed
    0 / 28 (0.00%)
    5 / 28 (17.86%)
         occurrences all number
    0
    5
    Eye disorders
    Visualdisturbances
         subjects affected / exposed
    2 / 28 (7.14%)
    5 / 28 (17.86%)
         occurrences all number
    2
    5
    Gastrointestinal disorders
    Gastrointestinal symptoms
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 28 (3.57%)
         occurrences all number
    3
    1
    Psychiatric disorders
    Sleep disturbances
         subjects affected / exposed
    4 / 28 (14.29%)
    9 / 28 (32.14%)
         occurrences all number
    4
    9
    Depressed mood/anxiety
         subjects affected / exposed
    2 / 28 (7.14%)
    3 / 28 (10.71%)
         occurrences all number
    2
    3
    Renal and urinary disorders
    Urgency
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 28 (3.57%)
         occurrences all number
    3
    1
    Musculoskeletal and connective tissue disorders
    Muscle pain
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 28 (0.00%)
         occurrences all number
    3
    0
    Fasciculations
         subjects affected / exposed
    1 / 28 (3.57%)
    4 / 28 (14.29%)
         occurrences all number
    1
    4
    Infections and infestations
    Common cold/infection
         subjects affected / exposed
    11 / 28 (39.29%)
    1 / 28 (3.57%)
         occurrences all number
    11
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26048580
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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