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Clinical trials for GHB

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   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    8 result(s) found for: GHB. Displaying page 1 of 1.
    EudraCT Number: 2013-005319-28 Sponsor Protocol Number: CNWL/AL/BACL/01 Start Date*: 2015-03-13
    Sponsor Name:Central and North West London NHS Foundation Trust
    Full Title: Improving GHB withdrawal with baclofen (The GHB Trial)
    Medical condition: GHB/GBL Withdrawal Syndrome
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-000616-70 Sponsor Protocol Number: HMR1964D/3001 Start Date*: 2004-12-17
    Sponsor Name:Aventis Pharmaceuticals, Inc.
    Full Title: Efficacy and safety of insulin glulisine compared with insulin lispro in children and adolescents with type 1 diabetes mellitus: a 26-week, multicenter, open, parallel clinical trial
    Medical condition: Type 1 diabetes mellitus
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed) NO (Completed) FI (Completed) SE (Completed) HU (Completed) GB (Completed) DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2005-002475-32 Sponsor Protocol Number: 050526 FMS Start Date*: 2005-12-07
    Sponsor Name:Charitè Universitätmeditin Berlin
    Full Title: Pilotstudy about endocrinilogical, peripherphysilogical and painreducing effects of Gamma-hydroxybutyrate in combination with operant-behaviour-therapeutic paintherapy with patients in Fibromyalgia...
    Medical condition: Patients with Fibromyalgia-syndrome
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-001039-23 Sponsor Protocol Number: Alc 2006 - 01 Start Date*: 2006-04-10
    Sponsor Name:ISTITUTO NEUROLOGICO "CARLO BESTA"
    Full Title: A Pilot Phase II Study for the evaluation of efficacy and tolerability of Gammaidroxybutyrate (ALCOVER) administered by oral route as add on treatmant in patients affected by DYT 11 Myoclonic Dysto...
    Medical condition: DYT 11 Myoclonic Dystonia.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029205 Nervous system disorders SOC
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-023815-33 Sponsor Protocol Number: GHB_CSP_CL_00008_03 Start Date*: 2011-01-05
    Sponsor Name:AVIR Green Hills Biotechnology Research Development Trade AG
    Full Title: Randomised, double-blind, placebo-controlled, phase I/II study of single dose GHB16L2 trivalent influenza vaccine in healthy adults
    Medical condition: The intended indication for the IMP GHB16L2 is prevention of influenza A (H1N1, H3N2) and B contained in the vaccine.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    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: 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: 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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