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Clinical trials for hypersomnia

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   43862   clinical trials with a EudraCT protocol, of which   7285   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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    10 result(s) found for: hypersomnia. Displaying page 1 of 1.
    EudraCT Number: 2009-011302-41 Sponsor Protocol Number: CHUBX2008/37 Start Date*: 2009-05-15
    Sponsor Name:CHU de Bordeaux
    Full Title: METHODE D’EVALUATION DE L’APTITUDE A LA CONDUITE CHEZ DES PATIENTS SOUFFRANT DE PATHOLOGIES DE L’EVEIL AutoSoP
    Medical condition: Narcoleptic patients with cataplexy or hypersomniacs
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028715 Narcolepsy with cataplexy LLT
    9.1 10020765 Hypersomnia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    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: 2008-007033-41 Sponsor Protocol Number: 1200 Start Date*: Information not available in EudraCT
    Sponsor Name:Hephata-Klinik
    Full Title: Pilot study on therapeutic efficacy of modafinil in idiopathic hypersomnie
    Medical condition: To test the efficacy, tolerability and safety of modafinil for the treatment of of excessiv daytime sleepiness in patients with idiopathic hypersomnia without long sleep time.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    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: 2018-001584-23 Sponsor Protocol Number: 7605 Start Date*: 2018-10-30
    Sponsor Name:University Hospital of Montpellier
    Full Title: "Microglial Activation in Narcolepsy Type 1: Positron Emission Tomography (PET) Study in [18F] DPA-714"
    Medical condition: To study in vivo microglial activation by PET [18F] DPA-714 in NT1 patients with recent evolution (appearance of the first symptoms - somnolence and cataplexy-less than 2 years ago) compared with c...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    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: 2022-002965-13 Sponsor Protocol Number: TAK-861-2003 Start Date*: 2023-04-11
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
    Medical condition: Narcolepsy with Cataplexy (Type 1) and Narcolepsy without Cataplexy (Type 2)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028713 Narcolepsy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Ongoing) IT (Ongoing) ES (Ongoing) NL (Trial now transitioned) FR (Trial now transitioned) SE (Trial now transitioned) FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-022648-19 Sponsor Protocol Number: P05898 Start Date*: 2011-11-16
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering Corporation
    Full Title: A 26-Week Open-Label, Flexible-Dose Trial of Asenapine Extension Treatment to P06107 in Pediatric Acute Manic or Mixed episodes Associated With Bipolar I Disorder
    Medical condition: Acute Manic or Mixed Episodes Associated with Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    14.0 10037175 - Psychiatric disorders 10068455 Bipolar I disorder, hypomanic LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-022744-21 Sponsor Protocol Number: AB08003 Start Date*: 2013-06-05
    Sponsor Name:AB Science
    Full Title: A 12-week, proof of concept prospective, randomized, double blind, phase 2a study to compare safety and efficacy of masitinib to placebo in the treatment of mood disorders in patients with antidepr...
    Medical condition: mood disorders associated to major depression or dysthymic disorder
    Disease: Version SOC Term Classification Code Term Level
    16.0 10037175 - Psychiatric disorders 10013982 Dysthymic disorder PT
    16.0 10037175 - Psychiatric disorders 10012374 Depressed mood PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-003452-14 Sponsor Protocol Number: SBC007C401 Start Date*: 2023-05-02
    Sponsor Name:Berlin Cures GmbH
    Full Title: A prospective, double-blind, randomised, parallel group, placebo controlled, multicentre, Phase II study to investigate the efficacy, GPCR autoantibody neutralising effect, safety, and tolerability...
    Medical condition: long Covid
    Disease: Version SOC Term Classification Code Term Level
    25.1 10021881 - Infections and infestations 10087832 COVID-19 rebound LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) ES (Ongoing) AT (Ongoing) FI (Ongoing)
    Trial results: (No results available)
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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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