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Clinical trials for primary insomnia and sleep and anxiety

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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    16 result(s) found for: primary insomnia and sleep and anxiety. Displaying page 1 of 1.
    EudraCT Number: 2017-003766-27 Sponsor Protocol Number: 848015011 Start Date*: 2018-07-18
    Sponsor Name:VU University Medical Centre
    Full Title: The DREAMING study: Efficacy of low dose amitriptyline and mirtazapine for insomnia disorder: a double-blind, randomized, placebo-controlled trial in general practice
    Medical condition: Insonnia disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10078083 Insomnia disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-002711-25 Sponsor Protocol Number: 039SC04253 Start Date*: 2005-08-01
    Sponsor Name:ANGELINI
    Full Title: DOSE-FINDING STUDY OF TRAZODONE IN THE TREATMENT OF PATIENTS WITH PRIMARY INSOMNIA
    Medical condition: TREATMENT OF THE INSOMNIA
    Disease: Version SOC Term Classification Code Term Level
    6.1 10022437 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed) SK (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2006-005711-10 Sponsor Protocol Number: OX22-006 Start Date*: 2007-02-26
    Sponsor Name:Orexo AB
    Full Title: A double-blind, randomised, two-period crossover study to evaluate the hypnotic effects and safety of sublingual zolpidem for the treatment of insomnia.
    Medical condition: Primary insomnia
    Disease: Version SOC Term Classification Code Term Level
    8.1 10036701 Primary insomnia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2004-004350-91 Sponsor Protocol Number: TAK-375/EC301 Start Date*: 2005-11-10
    Sponsor Name:Takeda Europe R&D Centre Ltd
    Full Title: A multicentre, randomised, double-blind, double-dummy, placebo-controlled study to evaluate the safety and efficacy of ramelteon compared to placebo with zopiclone as a reference arm in adults with...
    Medical condition: chronic insomnia
    Disease: Version SOC Term Classification Code Term Level
    8 10053851 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) AT (Completed) FI (Completed) IT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-000403-15 Sponsor Protocol Number: 01-06-TL-375-081 Start Date*: 2007-07-25
    Sponsor Name:Takeda Global Research & Development Centre (Europe) Ltd.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Polysomnography plus Outpatient Study to Determine the Safety and Efficacy of 4 mg Ramelteon in Adults with Chronic Insomnia
    Medical condition: insomnia characterised by difficulty with sleep onset
    Disease: Version SOC Term Classification Code Term Level
    9.1 10053851 Chronic insomnia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) FI (Completed) DE (Completed) FR (Completed) AT (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: 2020-004442-11 Sponsor Protocol Number: JAZ-01 Start Date*: 2020-12-01
    Sponsor Name:Zealand University Hospital
    Full Title: The effect of Melatonin in patients with Low Anterior Resection Syndrome
    Medical condition: Low anterior resection syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.1 10022117 - Injury, poisoning and procedural complications 10080023 Low anterior resection syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    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: 2019-002280-10 Sponsor Protocol Number: LBS180319 Start Date*: 2021-04-14
    Sponsor Name:St. Olav's University Hospital
    Full Title: Effects of intranasal oxytocin in the treatment of benzodiazepine withdrawal: A pilot randomized parallel group placebo-controlled trial
    Medical condition: Benzodiazepine withdrawal and craving
    Disease: Version SOC Term Classification Code Term Level
    20.0 10022891 - Investigations 10033329 Oxytocin PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2004-004009-10 Sponsor Protocol Number: CL3-20098-046 Start Date*: 2005-06-29
    Sponsor Name:Institut de Recherches Internationales Servier [...]
    1. Institut de Recherches Internationales Servier
    2. Laboratorios Servier S.L. (For Spain only)
    Full Title: Efficacy of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally on rest/activity circadian rhythms in outpatients with Major Depressive Disorder. A randomized, double-blind inte...
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    3.3 10025453 P.T.
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-005927-19 Sponsor Protocol Number: GESIDA11920 Start Date*: 2022-05-17
    Sponsor Name:Fundación SEIMC-GESIDA
    Full Title: Phase IV, randomized, multicenter, double-blind clinical trial designed to evaluate the safety and convenience of switching from Dolutegravir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir alafe...
    Medical condition: Human immunodeficiency virus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10053500 Human immunodeficiency virus transmission PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-008135-28 Sponsor Protocol Number: 01-281108 Start Date*: 2009-04-16
    Sponsor Name:Hull and East Yorkshire NHS Hospitals Trust
    Full Title: Effect of Sildenafil on Pulmonary Artery Pressure during hypoxia and exercise in Chronic Heart Failure
    Medical condition: We will investigate the effect of sildenafil on pulmonary artery pressure in Heart failure patients (impaired heart function). Patients will be recruited from the Heart Failure clinic at Castle Hil...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10002034 Anaemia LLT
    9.1 10040756 Sinusitis NOS LLT
    9.1 10016807 Fluid retention LLT
    9.1 10022437 Insomnia LLT
    9.1 10016998 Forehead headache LLT
    9.1 10010108 Common migraine LLT
    9.1 10002855 Anxiety LLT
    9.1 10044565 Tremor LLT
    9.1 10033987 Paresthesia LLT
    9.1 10006790 Burning sensation NOS LLT
    9.1 10020937 Hypoaesthesia LLT
    9.1 10007882 Cellulitis LLT
    9.1 10022000 Influenza LLT
    9.1 10038870 Retinal hemorrhage LLT
    9.1 10047544 Visual disturbance NOS LLT
    9.1 10047513 Vision blurred LLT
    9.1 10034960 Photophobia LLT
    9.1 10008795 Chromatopsia LLT
    9.1 10051819 Cyanopsia LLT
    9.1 10015910 Eye blood shot LLT
    9.1 10015946 Eye irritation LLT
    9.1 10038189 Red eye LLT
    9.1 10047531 Visual acuity reduced LLT
    9.1 10013036 Diplopia LLT
    9.1 10000173 Abnormal sensation in eye LLT
    9.1 10047340 Vertigo LLT
    9.1 10065027 Sudden deafness LLT
    9.1 10016825 Flushing LLT
    9.1 10006461 Bronchitis NOS LLT
    9.1 10015090 Epistaxis LLT
    9.1 10039092 Rhinitis NOS LLT
    9.1 10011224 Cough LLT
    9.1 10028735 Nasal congestion LLT
    9.1 10012735 Diarrhoea LLT
    9.1 10013946 Dyspepsia LLT
    9.1 10017869 Gastritis NOS LLT
    9.1 10017888 Gastroenteritis LLT
    9.1 10017885 Gastrooesophageal reflux disease LLT
    9.1 10019022 Haemorrhoids LLT
    9.1 10000060 Abdominal distension LLT
    9.1 10013781 Dry mouth LLT
    9.1 10001760 Alopecia LLT
    9.1 10015150 Erythema LLT
    9.1 10029410 Night sweats LLT
    9.1 10040913 Skin rash LLT
    9.1 10028411 Myalgia LLT
    9.1 10003988 Back pain LLT
    9.1 10018800 Gynaecomastia LLT
    9.1 10036661 Priapism LLT
    9.1 10052791 Erection increased (excl priapism) LLT
    9.1 10037660 Pyrexia LLT
    9.1 10042438 Sudden hearing loss, unspecified LLT
    9.1 10033425 Pain in extremity LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-000986-10 Sponsor Protocol Number: D1050296 Start Date*: 2011-12-14
    Sponsor Name:Sunovion Pharmaceuticals Inc.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, FLEXIBLE-DOSE, PARALLEL-GROUP STUDY OF LURASIDONE ADJUNCTIVE TO LITHIUM OR DIVALPROEX FOR THE PREVENTION OF RECURRENCE IN SUBJECTS WITH BIPOLAR I DISO...
    Medical condition: Bipolar disorder I depression
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004873 10004936 Bipolar depression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) SK (Completed) CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-000236-22 Sponsor Protocol Number: Study_protocol_CODEX-P_ver2_1 Start Date*: 2020-12-16
    Sponsor Name:Chronic Obstructive Pulmonary Disease Trial Network (COP:TRIN)
    Full Title: COPD EXacerbation and Pulmonary hypertension Trial - The effect of Sildenafil treatment to patients with COPD exacerbation and pulmonary hypertension
    Medical condition: This study will investigate treatment of patients with chronic obstructive pulmonary disease (COPD), who experience frequent exacerbations (AECOPD). Only patients with a minimum of 2 moderate AECOP...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004854 10019203 Head spinning LLT
    20.1 100000004852 10033405 Pain head LLT
    20.0 100000004852 10019218 Headache NOS LLT
    20.1 100000004856 10000460 Acid dyspepsia LLT
    22.1 100000004856 10013947 Dyspepsia aggravated LLT
    20.0 100000004856 10013948 Dyspepsia and other specified disorders of function of stomach LLT
    21.1 100000004856 10019328 Heartburn-like dyspepsia LLT
    20.1 100000004856 10064536 Functional dyspepsia LLT
    23.1 100000004856 10012727 Diarrhea LLT
    20.0 100000004859 10023222 Joint pain LLT
    21.0 100000004859 10025012 Lumbo-sacral pain LLT
    21.1 100000004859 10028322 Muscle pain LLT
    20.0 100000004856 10033394 Pain epigastric LLT
    21.1 100000004866 10016046 Facial flushing LLT
    20.0 100000004853 10013614 Double vision LLT
    21.0 100000004848 10005604 Blood in urine LLT
    20.0 100000004872 10018801 Gynecomastia LLT
    20.0 100000004872 10060603 Hematospermia LLT
    20.0 100000004851 10002272 Anemia LLT
    22.1 100000004853 10034961 Photophobia aggravated LLT
    20.0 100000004871 10023139 Jaundice NOS LLT
    20.0 100000004853 10030042 Ocular hyperemia LLT
    20.1 100000004853 10051304 Retinal bleeding LLT
    20.1 100000004853 10005889 Blurry vision LLT
    20.1 100000004856 10046272 Upper abdominal pain LLT
    20.0 100000004856 10038263 Reflux oesophagitis LLT
    20.0 100000004856 10047706 Vomiting NOS LLT
    20.0 100000004867 10016558 Fever LLT
    21.1 100000004862 10024969 Lower respiratory tract infection NOS LLT
    20.0 100000004859 10048317 Myalgia aggravated LLT
    21.1 100000004859 10003990 Back pain (without radiation) LLT
    20.1 100000004852 10020922 Hypesthesia LLT
    20.0 100000004852 10027605 Migraine NOS LLT
    21.1 100000004852 10044572 Tremor limb LLT
    20.1 100000004852 10044570 Tremor finger LLT
    20.0 100000004873 10002856 Anxiety attack LLT
    20.0 100000004873 10022442 Insomnia NOS LLT
    20.0 100000004855 10011232 Coughing LLT
    20.0 100000004862 10040756 Sinusitis NOS LLT
    20.0 100000004867 10014210 Edema LLT
    20.0 100000004867 10014211 Edema (NOS) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-004132-33 Sponsor Protocol Number: D1050304 Start Date*: 2013-05-02
    Sponsor Name:Sunovion Pharmaceuticals Inc.
    Full Title: A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone for the Treatment of Major Depressive Disorder with Mixed Features (Protocol No D1050304)
    Medical condition: Major Depressive Disorder (MDD)
    Disease: Version SOC Term Classification Code Term Level
    15.1 10037175 - Psychiatric disorders 10012378 Depression PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-005778-11 Sponsor Protocol Number: NP031112-08B03 Start Date*: 2009-01-29
    Sponsor Name:Noscira S.A.
    Full Title: A 14 week double-blind, placebo-controlled, randomized, escalating dose study to evaluate the safety and tolerability of three oral doses of NP031112, a novel GSK3 inhibitor, in mild to moderate Al...
    Medical condition: Alzheimer's Disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) DE (Completed)
    Trial results: (No results available)
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