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Clinical trials for Melatonin

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   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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    82 result(s) found for: Melatonin. Displaying page 4 of 5.
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    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: 2021-005996-37 Sponsor Protocol Number: JAZ-02 Start Date*: 2022-01-18
    Sponsor Name:Zealand University Hospital
    Full Title: Gene and protein expression profiles after treatment of actinic keratosis
    Medical condition: Actinic keratoses
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10000614 Actinic keratosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-003939-32 Sponsor Protocol Number: APL-510-008 Start Date*: 2005-03-23
    Sponsor Name:Alliance Pharmaceuticals Ltd
    Full Title: A double-blind placebo controlled cross-over study to determine if 1.5 and 3mg of APL510 can normalise sleep patterns in elderly subjects with difficulty in maintenance of sleep and/or initiating s...
    Medical condition: Difficulty in maintenance of sleep and/or initiating sleep onset
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    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: 2017-003321-14 Sponsor Protocol Number: P160942J Start Date*: 2018-08-03
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Prevention of DElirium with MELatonine in intensive care unit : prospective, multicenter, randomized, double-blind, placebo, multi-arm, multi-stage trial.
    Medical condition: patients in intensive care unit with invasive mechanical ventilation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10012218 Delirium PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    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
    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: 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: 2010-020912-12 Sponsor Protocol Number: VP-VEC-162-3202 Start Date*: 2010-08-26
    Sponsor Name:Vanda Pharmaceuticals Inc.
    Full Title: Open-label safety study of a 1-year 20 mg dose regimen of tasimelteon for the treatment of Non-24-Hour Sleep-Wake Disorder (N24HSWD) in blind individuals with no light perception.
    Medical condition: Non-24 Hour Sleep-Wake Disorder
    Disease: Version SOC Term Classification Code Term Level
    12.1 10013419 Disruptions of 24 hour sleep-wake cycle LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-021044-17 Sponsor Protocol Number: CLOCK_depression Start Date*: 2010-08-11
    Sponsor Name:Medizinische Universität Wien
    Full Title: The effect of agomelatine on CLOCK gene expression in patients with major depressive disorder and healthy controls: an exploratory study.
    Medical condition: Major depressive disorder (MDD), Seasonal affective disorder (subtype of MDD)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10012378 Depression LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    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: 2007-002875-15 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: 2016-000106-11 Sponsor Protocol Number: I14039 Start Date*: 2016-04-18
    Sponsor Name:Limoges Hospital
    Full Title: EVALUATION OF THE EFFICIENCY OF TREATMENT BY BUMETANIDE ON AUTISTIC CHILDREN WITH A KNOWN ETIOLOGY: MULTICENTER AND DOUBLE-BLIND STUDY WITH RANDOMIZED PARALLEL GROUP, AGAINST PLACEBO.
    Medical condition: autism
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029205 - Nervous system disorders 10003805 Autism PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2022-002372-36 Sponsor Protocol Number: 2022-16039 Start Date*: 2024-01-02
    Sponsor Name:Wageningen Research Stichting
    Full Title: The CanISleepinMS Study: Effect of cannabidiol (CBD) on sleep quality in patients with multiple sclerosis, a series of 15 randomised, placebo controlled N-of-1 trials
    Medical condition: Insomnia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    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: 2019-004478-24 Sponsor Protocol Number: OV101-18-002 Start Date*: 2020-06-05
    Sponsor Name:Ovid Therapeutics Inc.
    Full Title: An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals with Angelman Syndrome (ELARA)
    Medical condition: Angelman Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10049004 Angelman's syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-002907-17 Sponsor Protocol Number: OV101-19-001 Start Date*: 2020-02-19
    Sponsor Name:Ovid Therapeutics Inc.
    Full Title: A MulticeNter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of OV101 in PediaTric IndividUals With AngelmaN SyndromE (NEPTUNE)
    Medical condition: Angelman Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10049004 Angelman's syndrome PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-002657-60 Sponsor Protocol Number: STO-010 Start Date*: Information not available in EudraCT
    Sponsor Name:Klinikum der Universität
    Full Title: THE EFFECT OF NEU-P11 ON SYMPTOMS IN PATIENTS WITH D-IBS
    Medical condition: Irritable Bowel Syndrome (IBS)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10017947 - Gastrointestinal disorders 10021192 IBS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-002699-98 Sponsor Protocol Number: CB001-OL Start Date*: 2015-04-14
    Sponsor Name:University of Oxford
    Full Title: OxLith: Exploration of the short-term physical and psychological effects of lithium in mood instability
    Medical condition: Bipolar disorder with current mood instability
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004873 10004908 Bipolar affective disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-006706-69 Sponsor Protocol Number: DUAG9V1.03_10.06.2022 Start Date*: 2022-06-22
    Sponsor Name:Psychiatry – Aalborg University Hospital, Unit for Psychiatric Research
    Full Title: Lithium versus cariprazine in the acute phase treatment of bipolar depression: a pragmatic head-to-head open, randomized multicenter study. The 9th study of the Danish University Antidepressant Gro...
    Medical condition: Bipolar disorder, current depressive episode.
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10004911 Bipolar affective disorder, depressed LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
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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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