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    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.
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    Summary
    EudraCT Number:2013-001154-98
    Sponsor's Protocol Code Number:15660A
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-001154-98
    A.3Full title of the trial
    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 (13-506)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    fMRI scan study to find out how nalmefene works
    A.3.2Name or abbreviated title of the trial where available
    fMRI scan study to find out how nalmefene works (ver 1)
    A.4.1Sponsor's protocol code number15660A
    A.5.4Other Identifiers
    Name:HMR codeNumber:13-506
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorH Lundbeck A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportH Lundbeck A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.Sponsor: 2
    B.1.1Name of Sponsor
    B.1.3.4Country
    B.3.1 and B.3.2Status of the sponsor
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationH Lundbeck A/S
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street AddressOttiliavej 9
    B.5.3.2Town/ cityValby, Copenhagen
    B.5.3.3Post codeDK2500
    B.5.3.4CountryDenmark
    B.5.6E-mailLundbeckClinicalTrials@lundbeck.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Selincro 18 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderH Lundbeck A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSelincro 18 mg film-coated tablets
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnalmefene (as hydrochloride dihydrate)
    D.3.9.1CAS number 55096-26-9
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18.06
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nalmefene (Selincro) is indicated for the reduction of alcohol consumption in adults with alcohol dependence who have a high drinking risk level, without physical withdrawal symptoms and who do not require immediate detoxification.
    E.1.1.1Medical condition in easily understood language
    Alcohol dependence
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10001594
    E.1.2Term Alcohol dependence syndrome
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We'll use fMRI (functional magnetic resonance imaging) scans to find out more about where nalmefene acts in the brain and its effects on brain activity.

    The main aim is to find out if nalmefene affects the feeling of reward drinkers get when they have alcohol.
    E.2.2Secondary objectives of the trial
    In addition to the main aim of the study, there are several exploratory aims. We aim to find out if:

    * nalmefene makes drinkers less likely to act on impulse

    * nalmefene makes drinkers feel less stressed

    * nalmefene affects blood flow in the brain

    We’ll also obtain more information on how much nalmefene gets into the bloodstream, and how quickly the body gets rid of it, after a single dose taken by mouth.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men aged 20-65 years; drink, on average, at least 7½ units of alcohol daily; have drunk more than 7½ units of alcohol on at least 6 days in the last 4 weeks; willing and able to go without alcohol for one 3-night stay and one 2-night stay on the ward (but participants will have a slow injection of alcohol on each of the 3 full days they spend on the ward); in general good health, as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests (people who are alcohol-dependent are likely to have increased blood levels of substances linked to liver damage, so people with levels above the upper limit of the normal range for healthy men can be included at the discretion of the investigator); breath alcohol less than 0.02% at screening (when consent is given); able to communicate with study personnel; reliable, willing, and likely to comply with the protocol; willing to comply with the contraception and sperm donation requirements of the protocol; and consent to our informing their GP of their participation in the study, and to our entering their details into the over-volunteering database (TOPS).
    E.4Principal exclusion criteria
    We exclude participants who meet the following criteria:

    * have had more than 5 alcohol-free days in a row in the last 4 weeks; seeking or receiving treatment for alcohol dependence; have taken part in a support program (such as Alcoholics Anonymous) for alcohol dependence in the last 4 weeks; have taken medicines to treat alcohol dependence in the last 3 months— because participants must be able to tolerate injections of alcohol, and it would be unethical to ask participants seeking treatment for a drinking problem to expose themselves to alcohol;

    * at risk of, or has experienced, alcohol withdrawal; poor general health; abuse of drugs; breath alcohol greater than 0.02% at the screening visit; have ever taken medicines to treat ‘fits’ (seizures), type I diabetes, or cancer; have taken certain medicines in the 2 months before the study; have had a serious reaction to any medicine; unable to process certain sugars; have had any condition or operation that might affect the way the body absorbs medicines; have had any clinically significant disease or condition; at risk of suicide; had a major operation within the last 6 months; have taken part in a clinical trial of nalmefene; objection by GP on medical grounds — because they might increase the risk, or confound the assessment of nalmefene; mental illness or intoxication might compromise consent;

    * unwilling to comply with the contraception requirements of the protocol — because of the potential risk to babies conceived during the study;

    * claustrophobia; any condition which would make it difficult to lie still for very long; metal in the body (eg pacemaker, mechanical heart valve, artificial limb, replacement hip joint, shrapnel); have worked as a metal worker, machinist or welder; have a lot of tattoos — because participants must have 2 fMRI scans during the study;

    * employees of HMR, Imanova or the Faculty of Medicine at Imperial College; or close relatives of employees of HMR, Imanova or the Faculty of Medicine at Imperial College — because that is the policy of the sponsor, and to protect the confidentiality of employees; or

    * have donated blood, or taken part in another study, within the past 1 month; or don't agree not to donate blood, or take part in another study, during the 1 month after this study — because participants shouldn't expose themselves to unnecessary medicines more often than a few times a year, nor should they donate too much blood;


    We’ll study alcohol-dependent participants in good general health who are not seeking or receiving treatment for their drinking because:
    * the study medicine is used to treat alcohol dependence
    * the study requires participants to tolerate a slow injection of alcohol while lying in a scanner for up to 2 h, and remain alert so that they can complete our tests
    * it would be unethical to ask people undergoing or seeking treatment for a drinking problem to expose themselves to alcohol.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in the fMRI response in regions of the brain linked to a reward response (assessed by the monetary incentive delay task)
    E.5.1.1Timepoint(s) of evaluation of this end point
    About 4-6 h after dosing.
    E.5.2Secondary end point(s)
    There are several exploratory end points:

    *Changes in the fMRI response in regions of the brain linked to impulsive responses (assessed by the Go/NoGo task)

    *Changes in the fMRI response in regions of the brain linked to stress (assessed by the reaction to pictures from the International Affective Picture System)

    *Changes in the blood flow of the brain (assessed by an fMRI technique called arterial spin labelling).

    We’ll also obtain more information on the concentration of the nalmefene in the blood.
    E.5.2.1Timepoint(s) of evaluation of this end point
    fMRI endpoints will be measured about 4-6 h after dosing.

    The concentration of nalmefene in blood will be measured before dosing and frequently up to 24 h after dosing.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 22
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Alcohol-dependent adults. Subjects must not give consent while intoxicated.
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 22
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    We're doing this study in men who drink alcohol at levels that are considered a high risk to health, and who aren't seeking or receiving treatment for alcohol dependence.

    We won’t continue to provide nalmefene to participants at the end of the study. But we’ll offer participants advice about their drinking. If they want additional advice, we’ll refer them to their GP or support groups. As nalmefene is a licensed medicine, the GP may consider it as a treatment option for the participant.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-30
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