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Clinical trials for Insomnia AND 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
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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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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    70 result(s) found for: Insomnia AND Sleep Disorders. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2016-000827-16 Sponsor Protocol Number: AC-078A202 Start Date*: 2016-09-13
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: Multi-center, double-blind, randomized, placebo-controlled, 5-period, 5-treatment crossover, polysomnography dose-response study to assess the efficacy and safety of ACT-541468 in elderly subjects ...
    Medical condition: Insomnia disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10022437 Insomnia PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004259-59 Sponsor Protocol Number: AC-078A203 Start Date*: 2017-01-31
    Sponsor Name:Idorsia Pharmaceuticals Ltd
    Full Title: Multi-center, single-arm, open-label study in patients with Insomnia Disorder to validate the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™)
    Medical condition: Insomnia disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10022437 Insomnia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-004643-20 Sponsor Protocol Number: ID-078A302 Start Date*: 2018-06-18
    Sponsor Name:Idorsia Pharmaceuticals Ltd
    Full Title: Multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography study to assess the efficacy and safety of ACT-541468 in adult and elderly subjects with insomnia disorder
    Medical condition: Insomnia disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10022437 Insomnia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) FI (Completed) DE (Completed) SE (Completed) FR (Completed) CZ (Completed) BE (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2006-005303-34 Sponsor Protocol Number: EFC6072 Start Date*: 2007-06-01
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: Efficacy and safety of 2 mg/day M100907 on Sleep Maintenance Insomnia: a 6-week, multicenter, randomized, double-blind, placebo-controlled Polysomnographic study
    Medical condition: Sleep maintenance insomnia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2006-004942-18 Sponsor Protocol Number: LTE6673 Start Date*: 2007-03-14
    Sponsor Name:sanofi-aventis recherche et developpment
    Full Title: Efficacy and safety of 2 mg/day of M100907 on Sleep Maintenance Insomnia with a sub-study of the effect of M100907 on stable Type II Diabetes Mellitus: a One Year, multi-center, randomized, double-...
    Medical condition: sleep maintenance insomnia
    Disease: Version SOC Term Classification Code Term Level
    9.0 10022437 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) IT (Prematurely Ended) DE (Prematurely Ended) BE (Completed) ES (Completed) AT (Prematurely Ended) GR (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-005194-56 Sponsor Protocol Number: AC-057A301 Start Date*: 2008-07-06
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: Multi center, double blind, randomized, placebo controlled, active reference, parallel group polysomnography study to assess the efficacy and safety of a 16 day oral administration of ACT 078573 in...
    Medical condition: Chronic primary insomnia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10022437 Insomnia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) SE (Completed) AT (Completed) HU (Completed) SK (Completed) DE (Completed) FI (Completed) ES (Completed) CZ (Completed) FR (Completed) DK (Completed) GB (Completed) IT (Completed) BG (Completed)
    Trial results: View results
    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: 2015-003154-40 Sponsor Protocol Number: MK-4305-061 Start Date*: 2017-01-11
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Subjects with Alzheimer’s Disease
    Medical condition: Insomnia
    Disease: Version SOC Term Classification Code Term Level
    19.0 10037175 - Psychiatric disorders 10022437 Insomnia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-000037-36 Sponsor Protocol Number: KLF/K/010710 Start Date*: Information not available in EudraCT
    Sponsor Name:MCM Klosterfrau GmbH & Co. KG
    Full Title: Open label clinical trial to investigate the physiological effects on sleep of Nervenruh Baldrian Forte 600 in patients with primary insomnia
    Medical condition: Primary (psychophysiologic) insomnia
    Disease: Version SOC Term Classification Code Term Level
    13.1 10037175 - Psychiatric disorders 10036701 Primary insomnia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Ongoing)
    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: 2007-001688-31 Sponsor Protocol Number: 604296B Start Date*: 2007-06-04
    Sponsor Name:Larime company of the Mediscis group
    Full Title: Monitoring des états cognitifs chez des sujets volontaires sains, sur 2 périodes, l'une avant et après administration d'une dose unique de Zolpidem, l'autre sans administration de traitement
    Medical condition: It's a phase II study performed on healthy volonteers. Zolpidem (DCI) will be administered to the volunteers in order to inducing a drowsiness and a hypoattentiveness. Zolpidem is indicated in the ...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10022437 Insomnia LLT
    Population Age: Adults Gender: Male
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-004642-20 Sponsor Protocol Number: ID-078A301 Start Date*: 2018-07-02
    Sponsor Name:Idorsia Pharmaceuticals Ltd
    Full Title: Multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography study to assess the efficacy and safety of ACT-541468 in adult and elderly subjects with insomnia disorder
    Medical condition: Insomnia disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10022437 Insomnia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) DE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-001966-87 Sponsor Protocol Number: FCD-LOR-1402 Start Date*: 2015-07-30
    Sponsor Name:FERRER INTERNACIONAL, S.A.
    Full Title: Double-blind, randomized, placebo-controlled cross-over dose finding study of two doses of lorediplon in adult patients with insomnia disorder
    Medical condition: Insomnia disorder
    Disease: Version SOC Term Classification Code Term Level
    18.0 10037175 - Psychiatric disorders 10022437 Insomnia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Completed) HR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000826-21 Sponsor Protocol Number: AC-078A201 Start Date*: 2016-09-13
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: Multi-center, double-blind, randomized, placebo-controlled, active reference, parallel-group, polysomnography dose response study to assess the efficacy and safety of ACT-541468 in adult subjects w...
    Medical condition: Insomnia disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10022437 Insomnia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) HU (Completed) ES (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: 2007-005236-92 Sponsor Protocol Number: 21106 Start Date*: 2008-04-22
    Sponsor Name:NV Organon
    Full Title: A 6-month, double-blind, randomized, placebo-controlled, parallel group outpatient trial, investigating the efficacy and safety of Org 50081 in adult patients with chronic primary insomnia.
    Medical condition: Primary insomnia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036701 Primary insomnia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) FR (Completed) HU (Prematurely Ended) SE (Completed) NL (Completed) DE (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-000691-94 Sponsor Protocol Number: CHUBX2014/35 Start Date*: 2016-01-29
    Sponsor Name:CHU de Bordeaux
    Full Title: Self-help program for hypnotics withdrawal in insomniac patients: A randomized controlled clinical trial.
    Medical condition: Insomnia Chronic hypnotic users
    Disease: Version SOC Term Classification Code Term Level
    18.0 10037175 - Psychiatric disorders 10022437 Insomnia PT
    18.0 100000004869 10013662 Drug and chemical abuse HLT
    18.0 10037175 - Psychiatric disorders 10053851 Chronic insomnia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001463-39 Sponsor Protocol Number: E2006-G000-303 Start Date*: 2017-04-04
    Sponsor Name:Eisai Ltd.
    Full Title: A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel-Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder
    Medical condition: Treatment for 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) FI (Completed) PL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-004644-38 Sponsor Protocol Number: ID-078A303 Start Date*: 2018-10-30
    Sponsor Name:Idorsia Pharmaceuticals Ltd
    Full Title: Multi-center, double-blind, parallel-group, randomized, placebo-controlled, three doses, 40-week extension to studies ID-078A301 and ID-078A302 to assess the long term safety and tolerability of AC...
    Medical condition: Insomnia disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10022437 Insomnia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) FI (Completed) SE (Completed) DE (Completed) CZ (Completed) FR (Completed) HU (Completed) ES (Completed) BG (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-002523-33 Sponsor Protocol Number: 21108 Start Date*: 2007-10-31
    Sponsor Name:NV Organon
    Full Title: A double-blind, randomized, parallel group, placebo-controlled sleep laboratory efficacy and safety study with Org 50081 in elderly subjects with chronic primary insomnia
    Medical condition: Primary insomnia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036701 Primary insomnia LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) DK (Completed) GB (Completed) HU (Completed) CZ (Completed) BE (Completed) IT (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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