Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42336   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Interventional, randomized, double-blind, cross-over, placebo-controlled study to investigate the effects of nalmefene after single dose on the blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding in the monetary incentive delay task (MIDT), in non-treatment seeking subjects with alcohol dependence following alcohol challenge

    Summary
    EudraCT number
    2013-001154-98
    Trial protocol
    GB  
    Global end of trial date
    30 Oct 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    25 Jun 2016
    First version publication date
    25 Jun 2016
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    15660A
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01969617
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    HMR code: 13-506
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark,
    Public contact
    Lundbeck Clinical Trials, H Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    Lundbeck Clinical Trials, 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
    30 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effects of nalmefene after single dose on the blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) task following alcohol clamp challenge.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2008) and ICH Good Clinical Practice (1996)
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    14 Jan 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
    United Kingdom: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    The trial was conducted at one site in UK (single centre study)

    Pre-assignment
    Screening details
    Subjects who met each of the inclusion and none of the exclusion criteria were eligible to participate in the study

    Period 1
    Period 1 title
    overall trial (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
    Selincro/Placebo
    Arm description
    Subjects were randomised to receive 18 mg Selincro (nalmefene) on Day 1 and matching placebo on Day 8. There was a washout period of at least 1 week between dosing/scanning days.
    Arm type
    Experimental

    Investigational medicinal product name
    Selincro
    Investigational medicinal product code
    Other name
    Nalmefene
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose of Selincro 18 mg, orally

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose, tablet, orally

    Arm title
    Placebo/Selincro
    Arm description
    Subjects were randomised to receive placebo on Day 1 and 18 mg Selincro (nalmefene)on Day 8. There was a washout period of at least 1 week between dosing/scanning days.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose, tablet, orally

    Investigational medicinal product name
    Selincro
    Investigational medicinal product code
    Other name
    Nalmefene
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose of Selincro 18 mg, orally

    Number of subjects in period 1
    Selincro/Placebo Placebo/Selincro
    Started
    11
    11
    Completed
    11
    10
    Not completed
    0
    1
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    -

    Reporting group values
    overall trial Total
    Number of subjects
    22 22
    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)
    22 22
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    22 22
    Race
    Units: Subjects
        Asian
    1 1
        Black or African American
    2 2
        White
    18 18
        Other
    1 1

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Selincro/Placebo
    Reporting group description
    Subjects were randomised to receive 18 mg Selincro (nalmefene) on Day 1 and matching placebo on Day 8. There was a washout period of at least 1 week between dosing/scanning days.

    Reporting group title
    Placebo/Selincro
    Reporting group description
    Subjects were randomised to receive placebo on Day 1 and 18 mg Selincro (nalmefene)on Day 8. There was a washout period of at least 1 week between dosing/scanning days.

    Subject analysis set title
    Selincro
    Subject analysis set type
    Full analysis
    Subject analysis set description
    18 mg Nalmefene

    Subject analysis set title
    Placebo
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Placebo

    Primary: Blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) task

    Close Top of page
    End point title
    Blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) task
    End point description
    End point type
    Primary
    End point timeframe
    4-6 hours after dosing
    End point values
    Selincro Placebo
    Number of subjects analysed
    18
    18
    Units: Percent change
    16
    25
    Statistical analysis title
    Reward respond signal (activity)
    Statistical analysis description
    The analysis was a paired t-test (a linear mixed-effects model, with subject as the random effect and drug condition as the fixed effect). Data were excluded in the MIDT for three sessions (head movement), so 18 subjects were included in the analysis
    Comparison groups
    Selincro v Placebo
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    = 0.013
    Method
    Mixed models analysis
    Confidence interval
    Notes
    [1] - Mixed effect Model Repeat Measurement

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From dosing to end of study
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Selincro
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    Selincro Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Selincro Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 21 (47.62%)
    4 / 22 (18.18%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 21 (28.57%)
    0 / 22 (0.00%)
         occurrences all number
    6
    0
    Sinus Headache
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Vessel Puncture Site Haematoma
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Catheter Site Pain
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 21 (19.05%)
    0 / 22 (0.00%)
         occurrences all number
    4
    0
    Vomiting
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    Dyspepsia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis Allergic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1

    More information

    Close Top of page

    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
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA