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Clinical trials for Hypnotics

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   44351   clinical trials with a EudraCT protocol, of which   7378   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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    20 result(s) found for: Hypnotics. Displaying page 1 of 1.
    EudraCT Number: 2008-002003-75 Sponsor Protocol Number: EPU-P35 Start Date*: 2008-07-11
    Sponsor Name:Maastricht University
    Full Title: Residual effects of zopiclone 7.5 mg on cognition and driving performance in insomnia patients chronically using hypnotics
    Medical condition: Primary insomnia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036701 Primary insomnia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-003365-99 Sponsor Protocol Number: NL62809.068.17 Start Date*: 2017-11-08
    Sponsor Name:Maastricht University
    Full Title: The effects of ceasing opioid, benzodiazepine, or Z-hypnotic drug use on measures of driving performance and postural balance.
    Medical condition: Insomnia, Anxiety, chronic pain
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-002154-28 Sponsor Protocol Number: EPU-P31 Start Date*: 2007-06-27
    Sponsor Name:Maastricht University
    Full Title: Effects of insomnia and chronic use of hypnotics on driving performance
    Medical condition: Primary insomnia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036701 Primary insomnia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000691-94 Sponsor Protocol Number: CHUBX2014/35 Start Date*: 2016-01-29
    Sponsor Name:CHU de Bordeaux
    Full Title: Self-help program for hypnotics withdrawal in insomniac patients: A randomized controlled clinical trial.
    Medical condition: Insomnia Chronic hypnotic users
    Disease: Version SOC Term Classification Code Term Level
    18.0 10037175 - Psychiatric disorders 10022437 Insomnia PT
    18.0 100000004869 10013662 Drug and chemical abuse HLT
    18.0 10037175 - Psychiatric disorders 10053851 Chronic insomnia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-000914-37 Sponsor Protocol Number: NEU 1X Start Date*: 2004-08-12
    Sponsor Name:Neurim Pharmaceuticals (1991) Ltd
    Full Title: A DOUBLE-BLIND, PARALLEL GROUP, RANDOMISED, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CIRCADIN® 2MG IN THE IMPROVEMENT OF SLEEP QUALITY IN PATIENTS WITH INSOMNIA AGED 55-80 YEARS.
    Medical condition: Primary Insomnia in adults over 55 years
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-003745-14 Sponsor Protocol Number: D1448C00005 Start Date*: 2006-01-13
    Sponsor Name:AstraZeneca AB
    Full Title: A Multi-centre, Double-blind, Randomised Withdrawal, Parallel-group, Placebo-controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR®) as Monothe...
    Medical condition: Maintenance treatment of patients with Major Depressive Disorder
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) FI (Completed) SK (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-004193-27 Sponsor Protocol Number: NEU 112006 Start Date*: 2006-09-26
    Sponsor Name:Neurim Pharmaceuticals (1991) Ltd
    Full Title: A Double Blind, Parallel Group, Randomised, Placebo Controlled Study of Efficacy and Safety of CIRCADIN 2mg in the Treatment of Insomnia Patients with Low Endogenous Melatonin.
    Medical condition: Primary insomnia in adults with low endegenous melatonin.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-005087-93 Sponsor Protocol Number: Start Date*: 2006-11-17
    Sponsor Name:East Kent Hospitals NHS Trust
    Full Title: A randomized double blind placebo controlled trial of Memantine in the treatment of Agitation in Alzheimers Dementia
    Medical condition: Alzheimers dementia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-010642-57 Sponsor Protocol Number: IC4-20098-542 Start Date*: 2009-07-28
    Sponsor Name:Servier Slovensko, spol. s.r.o.
    Full Title: “Efficacy and safety of ValdoxanR given orally once a day for 24 weeks in patients with Major Depressive Disorder.” Open, national, multicentric clinical trial for the evaluation of the antidepress...
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    11.1 10057840 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed)
    Trial results: View results
    EudraCT Number: 2008-008722-73 Sponsor Protocol Number: PPP/2008 Start Date*: 2009-04-20
    Sponsor Name:AZIENDA OSPEDALIERA PISANA
    Full Title: ROLE OF PAROXETINE AS ADD-ON THERAPY TO GNRH AGONIST IN THE TREATMENT OF ENDOMETRIOSIS-RELATED CHRONIC PELVIC PAIN
    Medical condition: Endometriosis-associated pelvic pain
    Disease: Version SOC Term Classification Code Term Level
    9.1 10014778 Endometriosis LLT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002412-40 Sponsor Protocol Number: RVT-101-2002 Start Date*: 2017-01-30
    Sponsor Name:Axovant Sciences Ltd.
    Full Title: A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects with Dementia with Lewy Bodies (DLB)
    Medical condition: Dementia with Lewy bodies (DLB)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10067889 Dementia with Lewy bodies PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) ES (Completed) NL (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-004686-26 Sponsor Protocol Number: 0594-020 Start Date*: 2009-07-29
    Sponsor Name:Merck & Co., Inc.
    Full Title: Ensayo clínico multicéntrico, aleatorizado, doble ciego, en fase II y en dos etapas para evaluar la eficacia y la seguridad de MK-0594 en pacientes con alcoholismo. A Phase II Multicenter, Randomi...
    Medical condition: Dependencia Alcohólica Alcohol Dependence
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001594 Alcohol dependence syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) BE (Completed) DE (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2007-002875-15 Sponsor Protocol Number: TAK-375_107 Start Date*: 2007-12-11
    Sponsor Name:Takeda
    Full Title: A Single-Center, Randomized, Double-Blind, Double-Dummy Placebo Controlled, Cross-Over Study to Investigate the Next Morning Effects of Ramelteon (8mg), Zopiclone (7.5mg) and Placebo on Actual Driv...
    Medical condition: insomnia characterised by difficulty with sleep onset
    Disease: Version SOC Term Classification Code Term Level
    10.0 10040984 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2020-001176-15 Sponsor Protocol Number: BIA-91067-405 Start Date*: 2021-05-07
    Sponsor Name:Bial - Portela & Ca, S.A.
    Full Title: Open-label, single-arm, pilot study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated sleep disorders.
    Medical condition: Parkinson's disease patients with wearing-off motor fluctuations and associated sleep disorders.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-006942-33 Sponsor Protocol Number: 13/06/IBL/TP3 Start Date*: 2007-03-30
    Sponsor Name:Zentiva a.s.
    Full Title: Randomised, Double Dummy, Placebo Controlled, Multicentre, Parallel-Group, Single Dose Study to Compare the Analgesic Efficacy and Safety of IBALGIN Extra Fast /ibuprofen lysin/ to conventional Ibu...
    Medical condition: subject is indicated for outpatient surgical removal of one or more third molars, at least one of which is impacted in bone
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028819 Nausea vomiting and diarrhea LLT
    9.1 10019211 Headache LLT
    9.1 10017822 Gastric ulcer LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-004936-31 Sponsor Protocol Number: ICADTSIII Start Date*: 2014-05-28
    Sponsor Name:Ministry of Infrastructure and the Environment
    Full Title: Establish limits for fitness to drive with prolonged use of ICADTS class III medication
    Medical condition: Depression, anxiety, sleep disorders
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-003435-31 Sponsor Protocol Number: CL-758010 Start Date*: 2006-02-03
    Sponsor Name:Neurochem Inc.
    Full Title: A Phase III Study of the Efficacy and Safety of Alzhemed™ as Add-on Therapy in Mild to Moderate Alzheimer's Disease Patients.
    Medical condition: Alzheimer’s Disease (AD) is an irreversible, progressive neuro-degenartive disorder, characterized by gradual cognitive deficits associated with abnormal behaviour, personality changes, and which u...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Prematurely Ended) BE (Completed) SE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-005495-19 Sponsor Protocol Number: RVT-101-2001 Start Date*: 2016-06-13
    Sponsor Name:Axovant Sciences Inc.
    Full Title: A Phase 2b, double-blind, randomized, placebo-controlled study of RVT-101 in subjects with dementia with Lewy bodies (DLB).
    Medical condition: Dementia with Lewy Bodies
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029205 - Nervous system disorders 10067889 Dementia with Lewy bodies PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-002486-39 Sponsor Protocol Number: A0081128 Start Date*: 2006-11-01
    Sponsor Name:Pfizer Ltd, Ramsgate Road Sandwich, UK
    Full Title: A RANDOMIZED PLACEBO-CONTROLLED TRIAL OF THE EFFICACY AND TOLERABILITY OF FLEXIBLY DOSED PREGABALIN IN THE TREATMENT OF CANCER-INDUCED BONE PAIN.
    Medical condition: Treatment of moderate to severe chronic bone pain related to metastatic cancer.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10049038 Metastatic bone pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) DK (Prematurely Ended) FI (Completed) IT (Prematurely Ended) FR (Completed) HU (Prematurely Ended) CZ (Prematurely Ended) EE (Prematurely Ended) BG (Prematurely Ended) ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-003471-54 Sponsor Protocol Number: TAK-831-2002 Start Date*: 2018-05-14
    Sponsor Name:Millennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda
    Full Title: A Phase 2, 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of 3 Dose levels of TAK-831 in Adjunctive Treatment...
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed) CZ (Completed) DE (Prematurely Ended) BG (Completed) IT (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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