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Clinical trials for Eplivanserin

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   44336   clinical trials with a EudraCT protocol, of which   7366   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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    5 result(s) found for: Eplivanserin. Displaying page 1 of 1.
    EudraCT Number: 2008-003791-22 Sponsor Protocol Number: EFC10844 Start Date*: 2009-01-19
    Sponsor Name:sanofi-aventis Recherche & Développement
    Full Title: Efficacy and safety of eplivanserin 5mg/day in insomnia characterized by sleep maintenance difficulties: a 6-week, randomized, double-blind, placebo-controlled, polysomnography study
    Medical condition: insomnia characterized by sleep maintenance difficulties
    Disease: Version SOC Term Classification Code Term Level
    11.0 10027590 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) HU (Completed) DE (Completed) AT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-004644-35 Sponsor Protocol Number: PKD10491 Start Date*: 2015-03-17
    Sponsor Name:Sanofi-aventis
    Full Title: Single dose, open label safety, tolerability, pharmacokinetic and pharmacodynamic evaluation of three different eplivanserin doses in children aged 6-17 years with insomnia of various origins
    Medical condition: Sleep Initiation and Maintenance Disorders
    Disease: Version SOC Term Classification Code Term Level
    17.1 10037175 - Psychiatric disorders 10040984 Sleep disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-003082-16 Sponsor Protocol Number: LTE6262 Start Date*: 2006-02-03
    Sponsor Name:SANOFI-SYNTHELABO RECHERCHE
    Full Title: Efficacy and safety of eplivanserin 5mg/day on Sleep Maintenance Insomnia : a 12-week multicenter, randomized, double-blind, placebo-controlled study followed by an open treatment phase extension...
    Medical condition: SLEEP MAINTENANCE INSOMNIA
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) CZ (Completed) AT (Completed) GB (Completed) NL (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2005-003080-23 Sponsor Protocol Number: LTE6217 Start Date*: 2005-12-16
    Sponsor Name:Sanofi-aventis recherche et développement
    Full Title: Efficacy and safety of eplivanserin 5mg/day on sleep maintenance insomnia: a 12-week multicenter, randomized, double-blind, placebo-controlled study
    Medical condition: Sleep maintenance insomnia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) ES (Completed) GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2007-003822-28 Sponsor Protocol Number: EFC10480 Start Date*: 2008-03-05
    Sponsor Name:sanofi-aventis recherche et développement
    Full Title: Comparison of the safety and efficacy of eplivanserin and lormetazepam in the treatment of insomnia characterized by sleep maintenance difficulties. A 4 week, randomized, double-blind, comparative,...
    Medical condition: Chronic primary insomnia and sleep maintenance difficulties.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) PT (Completed) FR (Completed) ES (Completed) EE (Completed) FI (Completed)
    Trial results: View results
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    Query did not match any studies.
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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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