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Clinical trials for Nalmefene

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    8 result(s) found for: Nalmefene. Displaying page 1 of 1.
    EudraCT Number: 2013-001154-98 Sponsor Protocol Number: 15660A Start Date*: 2013-10-14
    Sponsor Name:H Lundbeck A/S [...]
    1. H Lundbeck A/S
    2.
    Full Title: 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 th...
    Medical condition: 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...
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004873 10001594 Alcohol dependence syndrome LLT
    Population Age: Adults Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-002334-11 Sponsor Protocol Number: 12014A Start Date*: 2009-03-13
    Sponsor Name:H. Lundbeck A/S
    Full Title: Nalmefene Efficacy Study I: Randomised, double-blind, placebo-controlled, parallel-group, efficacy study of 20 mg nalmefene, as needed use, in patients with alcohol dependence
    Medical condition: Alcohol dependence
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001594 Alcohol dependence syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SE (Completed) FI (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-002563-27 Sponsor Protocol Number: 12023A Start Date*: 2008-11-24
    Sponsor Name:H. Lundbeck A/S
    Full Title: Nalmefene Efficacy Study II: Randomised, double-blind, placebo-controlled, parallel-group, efficacy study of 20 mg nalmefene, as needed use, in patients with alcohol dependence
    Medical condition: Alcohol dependence
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001594 Alcohol dependence syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) PT (Completed) ES (Completed) IT (Completed) BE (Completed) PL (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2016-002805-21 Sponsor Protocol Number: RBHP_2016_DURIF Start Date*: 2016-10-07
    Sponsor Name:CHU Clermont-Ferrand
    Full Title:
    Medical condition:
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-002315-92 Sponsor Protocol Number: 12013A Start Date*: 2008-11-12
    Sponsor Name:H. Lundbeck A/S
    Full Title: A 52-week, randomised, double-blind, placebo-controlled, parallel-group, safety, tolerability and efficacy study of nalmefene, as needed use, in patients with alcohol dependence
    Medical condition: Alcohol dependence
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001594 Alcohol dependence syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) SK (Completed) EE (Completed) GB (Completed) LV (Completed) HU (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2014-000413-31 Sponsor Protocol Number: 15871A Start Date*: 2014-07-24
    Sponsor Name:H. Lundbeck A/S
    Full Title: Exploratory, interventional, open-label, fixed-dose study with Selincro® as-needed use, in alcohol dependent patients with liver impairment
    Medical condition: Alcohol dependence and liver impairment related to alcohol consumption
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004873 10001594 Alcohol dependence syndrome LLT
    17.1 100000004871 10021520 Impaired liver function LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-004688-30 Sponsor Protocol Number: 15892A Start Date*: 2014-05-19
    Sponsor Name:H. Lundbeck A/S
    Full Title: Interventional, open-label study of 18 mg Selincro® as needed use, in the treatment of patients with alcohol dependence in primary care
    Medical condition: Alcohol Dependency
    Disease: Version SOC Term Classification Code Term Level
    16.1 10037175 - Psychiatric disorders 10037175 Psychiatric disorders SOC
    16.1 10037175 - Psychiatric disorders 10001594 Alcohol dependence syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) ES (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-001946-93 Sponsor Protocol Number: NalGamb Start Date*: 2017-10-31
    Sponsor Name:National Instute of Health and Welfare
    Full Title: Double-blind, placebo-controlled randomised study on the efficacy of naloxone nasal spray for the treatment of gambling disorder
    Medical condition: Problem gambling
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000167845 10017657 Gambling pathological LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
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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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