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Clinical trials for 2013-001506-29

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
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    • 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   44335   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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    1 result(s) found for: 2013-001506-29. Displaying page 1 of 1.
    EudraCT Number: 2013-001506-29 Sponsor Protocol Number: P11-06/BF2.649 Start Date*: 2016-06-14
    Sponsor Name:Bioprojet
    Full Title: DOUBLE BLIND, MULTICENTRE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL TO EVALUATE SAFETY AND EFFICACY OF PITOLISANT IN CHILDREN FROM 6 TO LESS THAN 18 YEARS WITH NARCOLEPSY WITH/WITHOUT CATAPLEXY, FOLLOW...
    Medical condition: Narcolepsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028713 Narcolepsy PT
    20.0 10029205 - Nervous system disorders 10048322 Narcolepsy aggravated LLT
    20.0 10029205 - Nervous system disorders 10007737 Cataplexy PT
    20.0 10029205 - Nervous system disorders 10048323 Cataplexy aggravated LLT
    20.0 10029205 - Nervous system disorders 10028715 Narcolepsy with cataplexy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) FR (Trial now transitioned) DE (Prematurely Ended) NL (Completed) IT (Trial now transitioned)
    Trial results: (No results available)
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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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