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Clinical trials for Wakefulness

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   43925   clinical trials with a EudraCT protocol, of which   7306   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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    55 result(s) found for: Wakefulness. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2013-002545-10 Sponsor Protocol Number: OSU6162Open1309 Start Date*: 2014-01-08
    Sponsor Name:A. Carlsson Research AB
    Full Title: An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g P...
    Medical condition: Parkinsons disease Huntingtons disease Multiple scleros Brain trauma Stroke Myalgic encephalomyelitis Narcolepsy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002321-23 Sponsor Protocol Number: V1ComplexitDOC Start Date*: 2022-03-21
    Sponsor Name:University of Liège
    Full Title: Complexity-enhancing drugs to treat disorders of consciousness (DoC): a ketamine study
    Medical condition: Disorders of consciousness as Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS) after a coma due to acquired brain injury. Patients who emerged from the minimally consciou...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-003144-23 Sponsor Protocol Number: 2017/81 Start Date*: 2018-09-05
    Sponsor Name:University of Liège
    Full Title: Treating severe brain-injured patients with apomorphine : a behavioural and neuroimaging study
    Medical condition: Disorders of consciousness
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002282-35 Sponsor Protocol Number: rh-NGF Start Date*: 2020-05-13
    Sponsor Name:FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    Full Title: Nerve growth factor in pediatric severe traumatic brain injury : translational and clinical studies on a candidate biomarker and therapeutic drug
    Medical condition: Persistent unresponsive wakefulness syndrome (UWS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004863 10049615 Late effects of head trauma LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-005012-25 Sponsor Protocol Number: 05-07/BF 2.649 Start Date*: 2006-01-24
    Sponsor Name:BIOPROJET
    Full Title: Single blind study to assess the efficacy and tolerance of BF 2.649 in adults suffering from Attention Deficit/Hyperactivity Disorder
    Medical condition: Attention Deficit/Hyperactivity Disorder (AD/HD) in adults
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2005-000547-28 Sponsor Protocol Number: 070774 Start Date*: 2006-01-15
    Sponsor Name:Department of Psychiatry; Section of Sleep Research and Pharmacopsychiatry
    Full Title: EEG and ERP tomography by means of LORETA (Low-Resolution Brain Electromagnetic Tomography) identifying essential brain regions for vigilance and cognition in narcolepsy: double-blind, placebo-cont...
    Medical condition: Patients complaining of excessive daytime sleepiness will be recruited from our sleep clinics and will be subjected to neuropsychiatric, physical, laboratory and neurophysiological screening examin...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2008-008141-37 Sponsor Protocol Number: diab123v1.0 Start Date*: 2009-09-08
    Sponsor Name:Sherwood Forest Hospitals Foundation Trust
    Full Title: Effects of Exenatide on excess daytime sleepiness (EDS), wakefulness and driving performance in obese type-2 diabetes patients without sleep apnea – proof of concept study
    Medical condition: sleepiness and lethargy among obese patients with diabetes
    Disease: Version SOC Term Classification Code Term Level
    1 10012594 LLT
    1 10029883 LLT
    Population Age: Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2021-001453-31 Sponsor Protocol Number: CONMED3 Start Date*: Information not available in EudraCT
    Sponsor Name:Copenhagen University Hospital Rigshospitalet
    Full Title: Automated pupillometry and NIRS-EEG to detect signatures of consciousness in acute brain injury after apomorphine and methylphenidate stimulation: A placebo-controlled, randomized, cross-over study
    Medical condition: We investigate the possible effects of commercially available apomorphine and methylphenidate on signatures of consciousness in patients admitted to the ICU with acute disorder of consciousness, us...
    Disease: Version SOC Term Classification Code Term Level
    25.1 10029205 - Nervous system disorders 10013509 Disturbances in consciousness NEC HLT
    21.1 10029205 - Nervous system disorders 10067967 Brain injury PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-018414-69 Sponsor Protocol Number: 4305-029 Start Date*: 2010-05-23
    Sponsor Name:Merck & Co., Inc.
    Full Title: "Estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar la seguridad y la eficacia de MK-4305 en pacientes con insomnio primario -Es...
    Medical condition: Insomnio Primario /Primary Insomnia
    Disease: Version SOC Term Classification Code Term Level
    11 10036701 Insomnio primario LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) GB (Completed) FI (Completed) SE (Completed) DK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-018413-30 Sponsor Protocol Number: 4305-028 Start Date*: 2010-05-25
    Sponsor Name:Merck & Co., Inc.
    Full Title: "Estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar la seguridad y la eficacia de MK-4305 en pacientes con insomnio primario- Es...
    Medical condition: Insomnio Primario / Priramy Insomnia
    Disease: Version SOC Term Classification Code Term Level
    11 10036701 Insomnio primario LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) FI (Completed) DK (Completed) SE (Completed) FR (Completed) GB (Completed)
    Trial results: View results
    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 (Ongoing) BG (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003154-40 Sponsor Protocol Number: MK-4305-061 Start Date*: 2017-01-11
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Subjects with Alzheimer’s Disease
    Medical condition: Insomnia
    Disease: Version SOC Term Classification Code Term Level
    19.0 10037175 - Psychiatric disorders 10022437 Insomnia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-003822-28 Sponsor Protocol Number: EFC10480 Start Date*: 2008-03-05
    Sponsor Name:sanofi-aventis recherche et développement
    Full Title: Comparison of the safety and efficacy of eplivanserin and lormetazepam in the treatment of insomnia characterized by sleep maintenance difficulties. A 4 week, randomized, double-blind, comparative,...
    Medical condition: Chronic primary insomnia and sleep maintenance difficulties.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) PT (Completed) FR (Completed) ES (Completed) EE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2022-002418-18 Sponsor Protocol Number: 2021-10 Start Date*: 2022-11-09
    Sponsor Name:University Hospital Tübingen
    Full Title: AmaNtadine for NeuroenhancEment in acutE patients Study - A prospective pilot proof of concept phase IIb study in intensive and intermediate care unit patients (ANNES)
    Medical condition: Patients on Intermediate Care and Intensive Care Unit (IMC and ICU) with unresponsive wakefulness syndrome not otherwise explained
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-004448-20 Sponsor Protocol Number: Sarizotan/001/II/2015 Start Date*: 2016-11-28
    Sponsor Name:Newron Pharmaceuticals S.p.A.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Six-Month Study to Evaluate the Efficacy, Safety and Tolerability of Sarizotan in Patients with Rett Syndrome with Respiratory Symptoms
    Medical condition: Rett syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10039000 Rett's disorder LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2006-005303-34 Sponsor Protocol Number: EFC6072 Start Date*: 2007-06-01
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: Efficacy and safety of 2 mg/day M100907 on Sleep Maintenance Insomnia: a 6-week, multicenter, randomized, double-blind, placebo-controlled Polysomnographic study
    Medical condition: Sleep maintenance insomnia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2006-007074-29 Sponsor Protocol Number: VP-VSF-173-2001 Start Date*: 2007-04-20
    Sponsor Name:Vanda Pharmaceuticals Inc.
    Full Title: A randomized, double-blind, placebo-controlled, parallel study to investigate the efficacy and safety of three oral doses of VSF-173 (50 mg , 100 mg, and 200 mg total daily dose; given twice, 4 hou...
    Medical condition: excessive sleepiness
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015595 Excessive daytime sleepiness LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-006018-97 Sponsor Protocol Number: 4305-006 Start Date*: 2009-01-28
    Sponsor Name:Merck & Co., Inc.
    Full Title: A Phase IIb, Multicenter, Randomized, Double-Blind Placebo-Controlled, 2-period adaptive Crossover Polysomnography Study to Evaluate the Safety and Efficacy of MK-4305 in Patients With Primary Inso...
    Medical condition: Primary Insomnia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036701 Primary insomnia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-003080-23 Sponsor Protocol Number: LTE6217 Start Date*: 2005-12-16
    Sponsor Name:Sanofi-aventis recherche et développement
    Full Title: Efficacy and safety of eplivanserin 5mg/day on sleep maintenance insomnia: a 12-week multicenter, randomized, double-blind, placebo-controlled study
    Medical condition: Sleep maintenance insomnia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) ES (Completed) GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2012-005097-66 Sponsor Protocol Number: NCAG2512 Start Date*: 2014-07-14
    Sponsor Name:HOMVIORA Arzneimittel - Dr. Hagedorn GmbH & Co.
    Full Title: Effect of two homeopathic preparations on blood pressure in comparison to metoprolol (trade name Beloc-Zok® mite 47,5 mg) in 90 patients suffering from mild hypertonia. A prospective, confirmator...
    Medical condition: Patients suffering from mild hypertonia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (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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