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Clinical trials for melatonin (Circadin)

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
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    • 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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    20 result(s) found for: melatonin (Circadin). Displaying page 1 of 1.
    EudraCT Number: 2018-004048-50 Sponsor Protocol Number: 3-062-18 Start Date*: 2019-02-14
    Sponsor Name:University of Aberdeen [...]
    1. University of Aberdeen
    2. NHS Grampian
    Full Title: Double blind randomised controlled trial of exogenous administration of melatonin in chronic pain (DREAM-CP)
    Medical condition: Sleep disturbance in patients with chronic pain
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10040995 Sleep disturbance LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2011-005360-22 Sponsor Protocol Number: 2 Start Date*: 2012-06-29
    Sponsor Name:Vasa HVC
    Full Title: Does melatonin (CircadinR) worsen glucose tolerance in individuals with at (rs10830963) variant in the melatonin receptor 1B (MTNR1B) gene?
    Medical condition: Impaired glucose tolerance in healthy study persons
    Disease:
    Population Age: Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-004183-21 Sponsor Protocol Number: 2858 Start Date*: 2013-01-25
    Sponsor Name:North Bristol NHS Trust
    Full Title: A randomized, double blind, placebo controlled, cross over trial of Melatonin for the treatment of nocturia in adults with progressive multiple sclerosis, with an open label, single-arm extension s...
    Medical condition: Nocturia; Multiple Sclerosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-014388-38 Sponsor Protocol Number: NEUAZ1 Start Date*: 2009-09-28
    Sponsor Name:Neurim Pharmaceuticals Ltd
    Full Title: A double-blind, parallel group, randomized, placebo controlled study of the efficacy of Circadin® 2mg in alleviating sleep disturbances in patients with mild to moderate Alzheimer Disease (AD) tre...
    Medical condition: Insomnia in patients with mild to moderate Alzheimers Disease.
    Disease: Version SOC Term Classification Code Term Level
    10. 10036701 Primary Insomnia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (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: 2012-005255-17 Sponsor Protocol Number: Start Date*: 2014-09-05
    Sponsor Name:University of Leeds
    Full Title: Chronotherapeutic lifestyle intervention for diabetes and obesity to reset the circadian rhythm and improve cardiometabolic risk in the European population
    Medical condition: first-degree relatives of individuals with type 2 diabetes.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-002436-82 Sponsor Protocol Number: EC11-441 Start Date*: 2012-12-13
    Sponsor Name:Isabel Pinilla Lozano
    Full Title: Melatonin effects on visual and sleep patterns anomalies in subjects diagnosed with Retinitis Pigmentosa
    Medical condition: To evaluate the sleep quality in patients with Retinitis Pigmentosa
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-000281-23 Sponsor Protocol Number: Oxford University(None) Start Date*: 2009-09-10
    Sponsor Name:University of Oxford
    Full Title: Melatonin in Acute Mania Investigation (MIAMI-UK)
    Medical condition: Bipolar Disorder (mania and hypomania)
    Disease: Version SOC Term Classification Code Term Level
    12 10000852 Acute Mania LLT
    12 10021030 Hypomania LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-006795-30 Sponsor Protocol Number: Satauni Start Date*: 2009-01-16
    Sponsor Name:Institute of Clinical Medicine, Family Medicine, University of Turku
    Full Title: Controlled-release melatonin in fast withdrawal of temazepam, zopiclone or zolpidem in elderly persons with insomnia
    Medical condition: Individuals over 55 years with primary insomnia and DDD need of temazepam, zopiclone or zolpidem
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036701 Primary insomnia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-006452-22 Sponsor Protocol Number: maple b Start Date*: 2009-04-01
    Sponsor Name:Academic Medical Centre
    Full Title: The effects of melatonin in the treatment of delirium
    Medical condition: Delirium in elderly patients (65 yrs and older) acutely admitted to the ward of internal medicine.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012218 Delirium LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-001832-23 Sponsor Protocol Number: NEU_CH_7911 Start Date*: 2013-10-23
    Sponsor Name:Neurim Pharmaceuticals (1991) Ltd.
    Full Title: A RANDOMIZED, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF CIRCADIN® TO ALLEVIATE SLEEP DISTURBANCES IN CHILDREN WITH NEURODEVELOPMENTAL DISABILITIES
    Medical condition: SLEEP DISTURBANCES IN CHILDREN WITH NEURODEVELOPMENTAL DISABILITIES
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004873 10040997 Sleep disturbances LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA FI (Completed) GB (Completed) NL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-004138-33 Sponsor Protocol Number: EnuMel-11 Start Date*: 2011-12-23
    Sponsor Name:Søren Rittig
    Full Title: The effect of melatonin on nocturnal enuresis
    Medical condition: nocturnal enuresis
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004857 10029453 Nocturnal enuresis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    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: 2020-001530-35 Sponsor Protocol Number: MeCOVID Start Date*: 2020-04-09
    Sponsor Name:Fundación para la Investigación Biomédica del Hospital La Paz (FIBHULP)
    Full Title: Randomized multicenter clinical trial to evaluate the efficacy of melatonin in the prophylaxis of SARS-CoV-2 infection in high-risk contacts. COVID-19
    Medical condition: SARS-CoV-2 infection in high-risk contacts
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-000991-33 Sponsor Protocol Number: PI10/02877 Start Date*: 2012-07-13
    Sponsor Name:Instituto Aragonés de Ciencias de la Salud
    Full Title: Impact of melatonin in the pretreatment of organ donor and the influence in the evolution of liver transplant: a prospective, randomised double-blind study.
    Medical condition: Organ Transplant
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-005017-12 Sponsor Protocol Number: EyeADHD-01 Start Date*: 2014-03-31
    Sponsor Name:Parnassia Bavo Groep - PsyQ
    Full Title: Looking into the eye of ADHD. Investigating the relationship between ADHD, the delayed circadian rhythm and the functioning of the eye.
    Medical condition: Adults with ADHD and suboptimal eye functioning.
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004873 10064104 ADHD LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2008-002164-34 Sponsor Protocol Number: 12495A Start Date*: 2009-02-11
    Sponsor Name:H. Lundbeck A/S
    Full Title: Randomised, double-blind, 3-way crossover, single dose, placebo-controlled study investigating the effect on postural instability of melatonin and zolpidem in healthy elderly subjects
    Medical condition: Effect on postural instability of Melatonine and Zolpidem in healthy elderly subjects
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-005254-30 Sponsor Protocol Number: EuRhythDiaII Start Date*: 2013-12-27
    Sponsor Name:University Medical Center Hamburg-Eppendorf
    Full Title: Multicenter, randomized, double-blind, placebo controlled trial of 2 mg melatonin for circadian phase adjustment and improvement of metabolic control in night shift workers
    Medical condition: Insomnia because of disturbed sleep-work-rhythm
    Disease: Version SOC Term Classification Code Term Level
    17.0 10037175 - Psychiatric disorders 10032168 Other insomnia LLT
    17.0 10037175 - Psychiatric disorders 10022443 Insomnia related to another mental condition PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-002697-37 Sponsor Protocol Number: 14/0382 Start Date*: 2015-04-15
    Sponsor Name:University College London
    Full Title: Single-centre open label exploratory phase IIb pilot study of exogenous oral Melatonin for the treatment of Nocturia in adults with Parkinson’s disease
    Medical condition: Parkinson's Disease Nocturia
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    17.1 10029205 - Nervous system disorders 10034007 Parkinson's disease NOS LLT
    Population Age: Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-024065-46 Sponsor Protocol Number: 2010-379 Start Date*: 2011-05-03
    Sponsor Name:Lone Baandrup
    Full Title: Melatonin vs. placebo til nedtrapning af benzodiazepiner hos patienter med skizofreni: et randomiseret klinisk forsøg (SMART)
    Medical condition: Patienter med kronisk skizofreni og i længerevarende behandling med en kombination af antipsykotika og benzodiazepiner.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10039635 Schizophrenia schizoaffective LLT
    14.1 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    14.1 10037175 - Psychiatric disorders 10009134 Chronic schizophrenia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (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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