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Clinical trials for Sodium oxybate

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   44334   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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    19 result(s) found for: Sodium oxybate. Displaying page 1 of 1.
    EudraCT Number: 2011-006336-23 Sponsor Protocol Number: AGO/2011/014 Start Date*: 2013-07-01
    Sponsor Name:University Hospital Ghent
    Full Title: The effects of sodium oxybate in patients with chronic fatigue syndrome
    Medical condition: Chronic fatigue syndrome
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004867 10066564 Chronic fatigue LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-004049-19 Sponsor Protocol Number: NL77938.018.23 Start Date*: 2023-10-13
    Sponsor Name:Amsterdam UMC
    Full Title: Sodium oxybate as a potential new treatment for catatonia in patients with depression, bipolar disorder or a psychotic disorder, a randomized controlled trial. The Laborit study.
    Medical condition: Catatonia in patients with depression, bipolar disorder or a psychotic disorder
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004122-15 Sponsor Protocol Number: UF9889 Start Date*: 2018-03-13
    Sponsor Name:University Hospital of Montpellier
    Full Title: A randomized, double-blind, placebo-controlled trial comparing the efficacy and tolerance of sodium oxybate in patients affected with idiopathic hypersomnia.
    Medical condition: current idiopathic hypersomnia (ICSD-3)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-000575-14 Sponsor Protocol Number: SMO032/10/03 Start Date*: 2012-05-09
    Sponsor Name:D&A PHARMA
    Full Title: Randomized, multicenter, double-blind, placebo-controlled study of the safety and efficacy of 4 dose regimens of SMO.IR, an oral solid formulation of sodium oxybate, in the maintenance of alcohol a...
    Medical condition: maintenance of alcohol abstinence in recently abstinent alcohol-dependent patients
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004873 10031519 Other and unspecified alcohol dependence LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) CZ (Completed) AT (Completed) IT (Completed) SK (Completed) DE (Completed) ES (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-002222-30 Sponsor Protocol Number: 06-015 Start Date*: 2007-08-28
    Sponsor Name:Jazz Pharmaceuticals Inc.
    Full Title: Single- and Multiple-Dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Sodium Oxybate (Xyrem®) in Subjects with Moderate to Severe Essential Tremor
    Medical condition: Patients undergoing moderate or severe classic essential tremor
    Disease: Version SOC Term Classification Code Term Level
    9.1 10032297 Other nervous system complications LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-004846-28 Sponsor Protocol Number: NL60118.058.17 Start Date*: 2018-11-20
    Sponsor Name:Leiden University Medical Center
    Full Title: Efficacy of Sodium Oxybate to promote sleep in the ICU: A randomized controlled trial
    Medical condition: Sleep disturbance
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-002969-35 Sponsor Protocol Number: P40919/SAFFE2012 Start Date*: 2013-08-19
    Sponsor Name:Imperial College
    Full Title: Slow-wave sleep and daytime functioning in chronic fatigue syndrome: effects of sodium oxybate
    Medical condition: Chronic fatigue syndrome
    Disease: Version SOC Term Classification Code Term Level
    16.0 10018065 - General disorders and administration site conditions 10008874 Chronic fatigue syndrome PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2005-004417-15 Sponsor Protocol Number: DEV/ASP/00645.2006 Start Date*: 2006-04-18
    Sponsor Name:UCB Pharma Ltd
    Full Title: Single center, therapeutic exploratory clinical trial to evaluate the safety of sodium oxybate (Xyrem) 500 mg/mL oral solution on potential endocrine changes at currently labeled therapeutic dose r...
    Medical condition: Cataplexy in adult patients with narcolepsy
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-001834-33 Sponsor Protocol Number: OXYLIFE Start Date*: 2020-10-20
    Sponsor Name:LABORATORIO FARMACEUTICO CT SRL
    Full Title: Efficacy and safety of Sodium Oxybate in reducing alcohol consumption and maintaining abstinence in alcohol-dependent subjects with high and very high drinking risk level. “OXYLIFE Study“
    Medical condition: Alcohol addiction
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    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: 2016-000359-29 Sponsor Protocol Number: CLFT218-1501 Start Date*: 2016-11-09
    Sponsor Name:Flamel Ireland Limited (trading under the business name Avadel Ireland)
    Full Title: A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT...
    Medical condition: The treatment of cataplexy and excessive daytime sleepiness on narcolepsy.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10007738 Cataplexy and narcolepsy LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DK (Prematurely Ended) DE (Completed) GB (Completed) FI (Completed) CZ (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-004342-28 Sponsor Protocol Number: PKFT218-1602 Start Date*: 2017-10-30
    Sponsor Name:Flamel Ireland Ltd trading under the business name Avadel Ireland
    Full Title: A comparative, open label, randomized, 2 periods, 2 sequence crossover study to assess the relative bioavailability of sodium oxybate for extended release oral suspension (FT218) formulation (singl...
    Medical condition: A trial on healthy volunteer fore the development of a treatment for cataplexy and excessive daytime sleepiness in narcolepsy.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10007738 Cataplexy and narcolepsy LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    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
    EudraCT Number: 2006-006075-20 Sponsor Protocol Number: 06-009 Start Date*: 2007-08-20
    Sponsor Name:Jazz Pharmaceuticals, Inc.
    Full Title: Estudio aleatorizado, doble ciego, controlado con placebo, de la seguridad y eficacia de Xyrem® (oxibato sódico) en sujetos con fibromialgia (A Randomized, Double-Blind, Placebo-Controlled, Safety...
    Medical condition: fibromialgia
    Disease: Version SOC Term Classification Code Term Level
    8.1 10048439 Fibromyalgia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Ongoing) NL (Completed) PL (Completed) GB (Completed) IT (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-000084-27 Sponsor Protocol Number: P10-01/BF2.649 Start Date*: 2012-07-06
    Sponsor Name:Bioprojet
    Full Title: DOUBLE BLIND RANDOMIZED STUDY TO ASSESS THE EFFICACY OF BF2.649 COMPARED TO PLACEBO IN ADD-ON TO SODIUM OXYBATE IN THE TREATMENT OF NARCOLEPTIC PATIENTS WITH RESIDUAL EXCESSIVE DAYTIME SLEEPINESS...
    Medical condition: Narcolepsy
    Disease: Version SOC Term Classification Code Term Level
    15.1 10029205 - Nervous system disorders 10048322 Narcolepsy aggravated LLT
    15.1 10029205 - Nervous system disorders 10028713 Narcolepsy PT
    15.1 10029205 - Nervous system disorders 10007737 Cataplexy PT
    15.1 10029205 - Nervous system disorders 10048323 Cataplexy aggravated LLT
    15.1 10029205 - Nervous system disorders 10028715 Narcolepsy with cataplexy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) FI (Completed)
    Trial results: View results
    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: 2006-006291-38 Sponsor Protocol Number: 06-010 Start Date*: 2007-10-02
    Sponsor Name:Jazz Pharmaceuticals, Inc.
    Full Title: A Long-Term, Open-Label Safety and Efficacy Study of Xyrem (sodium oxybate) in Subjects with Fibromyalgia
    Medical condition: Fibromyalgia
    Disease: Version SOC Term Classification Code Term Level
    8.1 10048439 Fibromyalgia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) FR (Ongoing) NL (Completed) PL (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-003076-39 Sponsor Protocol Number: P11-05 Start Date*: 2012-10-10
    Sponsor Name:Bioprojet
    Full Title: A randomized, double blind study comparing BF2.649 (Pitolisant) to placebo in two parallel groups on the weekly frequency of cataplexy attacks and Excessive Daytime Sleepiness in narcoleptic patien...
    Medical condition: Narcolepsy with Cataplexy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10028715 Narcolepsy with cataplexy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2015-005035-41 Sponsor Protocol Number: THN102-201 Start Date*: 2018-05-29
    Sponsor Name:Theranexus SA
    Full Title: SAFETY AND EFFICACY OF THN102 ON SLEEPINESS IN NARCOLEPTIC PATIENTS
    Medical condition: This Proof-of-Concept, Phase IIa trial with THN102 should collect a sufficient body of information to assess efficacy and safety profile of THN102 versus modafinil alone in patient with a diagnosis...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028713 Narcolepsy PT
    20.0 10029205 - Nervous system disorders 10028715 Narcolepsy with cataplexy LLT
    20.0 10029205 - Nervous system disorders 10007738 Cataplexy and narcolepsy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (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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