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Clinical trials for Hypersomnolence

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    3 result(s) found for: Hypersomnolence. Displaying page 1 of 1.
    EudraCT Number: 2017-002127-16 Sponsor Protocol Number: UCAB-CT-03 Start Date*: 2017-08-24
    Sponsor Name:Umecrine Cognition AB
    Full Title: A phase IIa study of GR3027 in patients with idiopathic hypersomnia (IH) involving an open-label part to assess safety, tolerability and pharmacokinetics (PK) of a single oral GR3027 dose in female...
    Medical condition: Idiopathic hypersomnia (IH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10028714 Narcolepsy and hypersomnia HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed) DK (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2006-002088-18 Sponsor Protocol Number: H3A106104 Start Date*: 2006-10-12
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: An open label, dose escalation study with a double blind randomised placebo controlled withdrawal to examine the effects of the histamine H3 antagonist GSK189254 in patients with narcolepsy.
    Medical condition: Narcolepsy
    Disease: Version SOC Term Classification Code Term Level
    8.1 10028713 Narcolepsy LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (Prematurely Ended) NL (Prematurely Ended) AT (Completed) FI (Prematurely Ended) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-001311-79 Sponsor Protocol Number: JZP080-301 Start Date*: 2019-01-09
    Sponsor Name:Jazz Pharmaceuticals
    Full Title: A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) with an Open-label Safety Extension
    Medical condition: Treatment of Idiopathic Hypersomnia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10040989 Sleep disorder NOS LLT
    20.1 100000004852 10015595 Excessive daytime sleepiness LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (GB - no longer in EU/EEA) CZ (Completed) BE (Completed) DE (Completed) ES (Completed) FI (Completed) IT (Prematurely Ended)
    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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