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Clinical trials for Somnolence

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 ).  
     
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    69 result(s) found for: Somnolence. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2006-006804-12 Sponsor Protocol Number: ucb L059 Start Date*: 2007-03-15
    Sponsor Name:ErasmusMedical Center-Sophia
    Full Title: Levetiracetam (Keppra®) in neonates
    Medical condition: epileptic seizures in neonates admitted to the intensive care unit
    Disease: Version SOC Term Classification Code Term Level
    9.1 10041350 Somnolence neonatal LLT
    9.1 10013573 Dizziness LLT
    9.1 10004210 Behavioural disorder LLT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-013885-14 Sponsor Protocol Number: P06-10/BF2.649 Start Date*: 2009-11-12
    Sponsor Name:BIOPROJET
    Full Title: A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week ope...
    Medical condition: Excessive daytime sleepiness in Parkinson?s Disease Somnolencia diurna excesiva en la enfermedad de Parkinson.
    Disease: Version SOC Term Classification Code Term Level
    12.0 10015595 Excessive daytime sleepiness LLT
    12.0 10034005 Parkinson's disease and parkinsonism HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2009-012529-12 Sponsor Protocol Number: 0827703 Start Date*: 2009-06-10
    Sponsor Name:CHU de Toulouse
    Full Title: A randomised, REQUIP® IR-controlled, n-of-1, multiple crossover, pilot trial of the effect of REQUIP®CR on abnormal daytime somnolence in patients with Parkinson’s Disease
    Medical condition: parkinson's disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013113 Disease Parkinson's LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-003512-57 Sponsor Protocol Number: P 07-02/BF 2.649 Start Date*: 2007-08-24
    Sponsor Name:Bioprojet
    Full Title: Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD)
    Medical condition: Excessive daytime sleepiness associated to Parkinson disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10041014 Sleepiness LLT
    9.1 10061536 Parkinson's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-004475-31 Sponsor Protocol Number: THN102-202 Start Date*: 2018-04-17
    Sponsor Name:Theranexus S.A.
    Full Title: Randomised, double-blind, placebo-controlled, complete 3-way cross-over phase IIa trial to investigate safety and efficacy of two THN102 doses in subjects with excessive daytime sleepiness associa...
    Medical condition: Excessive daytime sleepiness associated with Parkinson’s disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    20.0 10029205 - Nervous system disorders 10041349 Somnolence PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (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: 2009-013886-24 Sponsor Protocol Number: P06-11 / BF2.649 Start Date*: 2010-03-03
    Sponsor Name:BIOPROJET
    Full Title: A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease
    Medical condition: Excessive daytime sleepiness in Parkinson’s Disease
    Disease: Version SOC Term Classification Code Term Level
    12.0 10015595 Excessive daytime sleepiness LLT
    12.0 10034005 Parkinson's disease and parkinsonism HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2004-002505-74 Sponsor Protocol Number: CEP1538/3034/ES/MN Start Date*: 2005-01-05
    Sponsor Name:Cephalon Europe, A Division of Cephalon UK Limited
    Full Title: A 6 month open-label, flexible-dosage study to assess the safety and effectiveness of PROVIGIL® (Modafinil) treatment in children and adolescents with excessive sleepiness associated with narcoleps...
    Medical condition: Excessive sleepiness associated with Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome.
    Disease: Version SOC Term Classification Code Term Level
    7.0 10015595 LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) FI (Completed) GB (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-019672-76 Sponsor Protocol Number: RBHP2010CAILLAUD Start Date*: 2010-10-12
    Sponsor Name:CHU de Clermont-Ferrand
    Full Title: Impact de la correction du déficit en vitamine D chez les patients porteurs de syndrome d’apnées- hypopnées obstructives du sommeil.
    Medical condition: Syndrome d’apnées du sommeil (SAHOS)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-004464-24 Sponsor Protocol Number: P04608 Start Date*: 2006-04-21
    Sponsor Name:Integrated Therapeutics Group, Inc
    Full Title: A Double-blind, Placebo-controlled, Randomized, Parallel-group Multicenter Study of Mometasone Furoate Nasal Spray on Sleep Disturbances and Daytime Somnolence in Subjects with Symptomatic Seasonal...
    Medical condition: Seasonal Allergic Rhinitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed) GB (Completed) NL (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-017248-14 Sponsor Protocol Number: P09-08/BF2.649–HAROSAI Start Date*: 2011-02-21
    Sponsor Name:BIOPROJET
    Full Title: BF2.649 in patients with Obstructive Sleep Apnoea syndrome (OSA), and treated by nasal Continuous Positive Airway Pressure (nCPAP), but still complaining of Excessive Daytime Sleepiness (EDS).
    Medical condition: Patients with Obstructive Sleep Apnoea syndrome (OSA), and treated by nasal Continuous Positive Airway Pressure (nCPAP), but still complaining of Excessive Daytime Sleepiness (EDS)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004852 10015595 Excessive daytime sleepiness LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Completed) FI (Completed) SE (Completed) DK (Prematurely Ended) BG (Completed)
    Trial results: View results
    EudraCT Number: 2008-002578-36 Sponsor Protocol Number: 2008/0817 Start Date*: 2008-09-10
    Sponsor Name:CHRU de LILLE
    Full Title: Etude d’efficacité et d’acceptabilité d’un traitement cholinergique dans l’apathie parkinsonienne “Cholinergic treatment in Parkinsonian Apathy: ChoPA - I”
    Medical condition: Parkinsonian Apathy without dementia and depression in spite of dopaminergic treatment
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-003506-27 Sponsor Protocol Number: BILA-3312/PED Start Date*: 2013-01-25
    Sponsor Name:FAES FARMA, S.A.
    Full Title: A multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and tolerability of 10 mg once daily bilastine in children from 2 to 11 years of age with e...
    Medical condition: Allergic Rhinoconjunctivitis and Chronic Urticaria
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) ES (Ongoing) PT (Completed) PL (Completed) HR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-003238-15 Sponsor Protocol Number: Schaefers0711 Start Date*: 2012-12-12
    Sponsor Name:KKRN Katholisches Klinikum Ruhrgebiet Nord GmbH
    Full Title: Quality of analgesia and side effect incidence and severity during postoperative pain management with Palexia® compared to Targin®
    Medical condition: Management of postoperative pain in trauma surgery patients (adults) requiring postoperative opiates for the management of postoperative pain.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004865 10036236 Postoperative pain relief LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-017251-94 Sponsor Protocol Number: P09-09/BF2.649 Start Date*: 2011-02-21
    Sponsor Name:Bioprojet
    Full Title: Efficacy and safety of BF2.649 in the treatment of Excessive Daytime Sleepiness in patients with Obstructive Sleep Apnoea syndrome (OSA), refusing the nasal continuous positive airway pressure (nCP...
    Medical condition: Excessive diurnal sleepiness in patients with moderate to severe Obstructive Sleep Apnoea (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004852 10015595 Excessive daytime sleepiness LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Completed) FI (Completed) SE (Completed) DK (Prematurely Ended) BG (Completed)
    Trial results: View results
    EudraCT Number: 2018-004057-25 Sponsor Protocol Number: RC21/18 Start Date*: 2019-10-02
    Sponsor Name:IRCCS MATERNO INFANTILE BURLO GAROFOLO
    Full Title: Oral Ibuprofene versus oral kethorolac for children with musculoskeletal injury: a double blind randomized controlled study.
    Medical condition: Pain is present in 78% of overall accesses in pediatric emergency rooms and, in most cases, it is acute and secondary to musculoskeletal trauma. Fifthy percent of patients report moderate to severe...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10033472 Pain of extremties LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    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 (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-021955-14 Sponsor Protocol Number: BUP3030 Start Date*: 2011-10-17
    Sponsor Name:Purdue Pharma L.P.
    Full Title: A Multicenter, Inpatient, Open-label Study to Characterize the Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Aged from Birth to 6 Years of Age...
    Medical condition: Acute moderate to severe pain requiring opioids for at least 24 hours in postoperative and prolonged endotracheal intubated patients
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10002182 Analgesia LLT
    14.0 10042613 - Surgical and medical procedures 10021415 Immediate postoperative analgesia LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-002235-26 Sponsor Protocol Number: OTR3002 Start Date*: 2011-10-26
    Sponsor Name:Purdue Pharma L.P.
    Full Title: An Open-label, Extension Study to Assess the Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children Who Completed the OTR3001 Study
    Medical condition: Opioid experienced paediatric patients aged 6-17 years with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10002182 Analgesia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) EE (Completed) ES (Completed) FI (Completed) DE (Completed) GR (Prematurely Ended) GB (Prematurely Ended) SK (Completed) BE (Completed) HU (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-003136-23 Sponsor Protocol Number: CRO1990 Start Date*: 2012-11-27
    Sponsor Name:Imperial College London
    Full Title: Lamotrigine And Borderline Personality Disorder: Investigating Long-Term Effectiveness
    Medical condition: Borderline Personality Disorder
    Disease: Version SOC Term Classification Code Term Level
    14.1 10040785 - Skin and subcutaneous tissue disorders 10042033 Stevens-Johnson syndrome PT
    14.1 10029205 - Nervous system disorders 10019211 Headache PT
    15.0 100000004856 10028821 Nausea with vomiting LLT
    14.1 10040785 - Skin and subcutaneous tissue disorders 10040913 Skin rash LLT
    14.1 10029205 - Nervous system disorders 10024264 Lethargy PT
    14.1 10029205 - Nervous system disorders 10013649 Drowsiness LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
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