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Clinical trials for Nervous System Diseases AND Narcolepsy AND Xyrem (sodium oxybate) oral solution

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   44338   clinical trials with a EudraCT protocol, of which   7368   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    3 result(s) found for: Nervous System Diseases AND Narcolepsy AND Xyrem (sodium oxybate) oral solution. Displaying page 1 of 1.
    EudraCT Number: 2014-001389-93 Sponsor Protocol Number: 13-005 Start Date*: 2015-08-27
    Sponsor Name:Jazz Pharmaceuticals
    Full Title: A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of Xyrem with an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Su...
    Medical condition: Narcolepsy with Cataplexy
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004852 10007738 Cataplexy and narcolepsy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) NL (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-000426-20 Sponsor Protocol Number: 15-006 Start Date*: 2016-09-05
    Sponsor Name:Jazz Pharmaceuticals
    Full Title: A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in Subjects with Narcolepsy with Cataplexy
    Medical condition: Treatment of cataplexy in narcolepsy Treatment of excessive daytime sleepiness (EDS) in narcolepsy
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004852 10015595 Excessive daytime sleepiness LLT
    20.0 100000004852 10007738 Cataplexy and narcolepsy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) DE (Completed) ES (Completed) FR (Completed) BE (Completed) FI (Completed) HR (Completed) NL (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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