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Clinical trials for Circadian rhythm sleep disorders

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   44335   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: Circadian rhythm sleep disorders. Displaying page 1 of 1.
    EudraCT Number: 2011-004520-35 Sponsor Protocol Number: VP-VEC-162-3204 Start Date*: 2012-12-06
    Sponsor Name:Vanda Pharmaceuticals Inc.
    Full Title: AN EXTENSION OPEN-LABEL SAFETY STUDY OF A 24-MONTH 20MG DOSE REGIMEN OF TASIMELTEON FOR THE TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER (N24HSWD) IN BLIND INDIVIDUALS WITH NO LIGHT PERCEPTION WHO ...
    Medical condition: Blind males or females with no conscious light perception and the complaint of a sleep-wake disorder associated with Non-24 Hour Sleep- Wake Disorder
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029205 - Nervous system disorders 10009191 Circadian rhythm sleep disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-000281-35 Sponsor Protocol Number: VP-VEC-162-3201 Start Date*: 2011-06-09
    Sponsor Name:Vanda Pharmaceuticals Inc.
    Full Title: A Multicenter, Randomized, Double-Mask, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of 20 mg Tasimelteon versus Placebo in Totally Blind Subjects with N24HSWD followed...
    Medical condition: Blind males or females with no conscious light perception and the complaint of a sleep-wake disorder associated with Non-24 Hour Sleep-Wake Disorder.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10009191 Circadian rhythm sleep disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-005475-40 Sponsor Protocol Number: VP-VEC-162-3502 Start Date*: 2022-06-08
    Sponsor Name:Vanda Pharmaceuticals Inc.
    Full Title: A multicenter, double-blind, randomized study to evaluate the effects of tasimelteon vs. placebo in participants with Delayed Sleep-Wake Phase Disorder (DSWPD)
    Medical condition: Delayed Sleep-Wake Phase Disorder (DSWPD)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029205 - Nervous system disorders 10041013 Sleep-wake schedule disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-004664-46 Sponsor Protocol Number: melmet Start Date*: 2008-07-29
    Sponsor Name:No Sponsor
    Full Title: Influence of methylphenidate on sleep and circadian rhythm in children with Attention-Deficit/Hyperactivity Disorder (ADHD)
    Medical condition: Sleep disorders in Attention-Deficit/ Hyperactivity Disorder (ADHD)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002189-39 Sponsor Protocol Number: 161802 Start Date*: 2017-12-11
    Sponsor Name:University of Oxford
    Full Title: A randomised placebo-controlled trial to assess the effect of melatonin on circadian sleep-wake disturbances in ocular disease.
    Medical condition: circadian sleep-wake disturbances associated with ocular disease.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10009191 Circadian rhythm sleep disorder PT
    21.1 10029205 - Nervous system disorders 10009191 Circadian rhythm sleep disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-003306-40 Sponsor Protocol Number: E2006-G000-202 Start Date*: 2018-02-27
    Sponsor Name:Eisai Ltd.
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study with Open-Label Extension Phase of the Efficacy and Safety of Lemborexant in Subjects with Irregular Sleep-Wake Rhy...
    Medical condition: Irregular Sleep-Wake Rhythm Disorder in Subjects with Mild to Moderate Alzheimer’s Disease Dementia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-003955-23 Sponsor Protocol Number: DR2 Start Date*: 2016-04-15
    Sponsor Name:Dept. of Ophthalmology, Rigshospitalet – Glostrup
    Full Title: Diabetic retinopathy: Effects of melatonin treatment on visual functions and circadian rhythm.
    Medical condition: Diabetic Retinopathy and Sleep disorder
    Disease: Version SOC Term Classification Code Term Level
    20.1 10015919 - Eye disorders 10012689 Diabetic retinopathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (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: 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: 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: 2017-000980-33 Sponsor Protocol Number: 42847922ISM2005 Start Date*: 2018-06-11
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Active- and Placebo-Controlled Polysomnography Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Subjects with Ins...
    Medical condition: Insomnia 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: DE (Completed) BE (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    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: 2013-004450-21 Sponsor Protocol Number: EMR200136-570 Start Date*: 2014-02-07
    Sponsor Name:Merck Serono S.p.A.
    Full Title: Multicenter, open-label, 12 weeks, phaseIV pRospectivE randomized study aimed at evaLuating whether sc IFN beta 1a (Rebif®) administered In the morning may affEct the severity of Flu-like syndrom...
    Medical condition: relapsing multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-004561-85 Sponsor Protocol Number: P1513/BF2.649 Start Date*: 2016-02-24
    Sponsor Name:Bioprojet Pharma
    Full Title: Efficacy and Safety of Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients with Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway P...
    Medical condition: Patients with Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, but Still Complaining of Excessive Daytime Sleepiness (EDS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004852 10015595 Excessive daytime sleepiness LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-019687-36 Sponsor Protocol Number: P09-15/BF2.649 Start Date*: 2010-07-15
    Sponsor Name:Bioprojet
    Full Title: Randomized, double-blind, placebo and comparator-controlled, parallel-group, multi-center trial assessing the effects of BF2.649 in the treatment of excessive daytime sleepiness in narcolepsy
    Medical condition: Narcolepsy
    Disease: Version SOC Term Classification Code Term Level
    12.1 10028713 Narcolepsy LLT
    12.1 10048322 Narcolepsy aggravated LLT
    12.1 10021235 Idiopathic narcolepsy LLT
    12.1 10007737 Cataplexy LLT
    12.1 10048323 Cataplexy aggravated LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) FI (Completed) HU (Completed) IT (Completed) ES (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2008-007866-46 Sponsor Protocol Number: P07-03 / BF 2.649 Start Date*: Information not available in EudraCT
    Sponsor Name:Bioprojet
    Full Title: Prospective, randomized, double-blind study, placebo-controlled, parallel-group, multi-center trial assessing the effects of BF2.649 in treatment of excessive daytime sleepiness in narcolepsy (HARM...
    Medical condition: Narcolepsy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028713 Narcolepsy LLT
    9.1 10048322 Narcolepsy aggravated LLT
    9.1 10021235 Idiopathic narcolepsy LLT
    9.1 10007737 Cataplexy LLT
    9.1 10048323 Cataplexy aggravated LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) FR (Completed) NL (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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