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Clinical trials for Down Syndrome

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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    167 result(s) found for: Down Syndrome. Displaying page 1 of 9.
    1  2  3  4  5  6  7  8  9  Next»
    EudraCT Number: 2010-021134-66 Sponsor Protocol Number: IJL-AFHT-TH10 Start Date*: Information not available in EudraCT
    Sponsor Name:Institut Jerome Lejeune
    Full Title: Efficacy assessment of systematic treatment with folinic acid and thyroid hormone on psychomotor development of Down Syndrome young children
    Medical condition: Down syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10044688 Trisomy 21 PT
    14.0 10010331 - Congenital, familial and genetic disorders 10013616 Down's syndrome LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2006-003359-19 Sponsor Protocol Number: GALPED1001 Start Date*: 2007-08-07
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: An open-label study of two single oral doses of galantamine, examining the pharmacokinetics, safety, and tolerability in children with Down syndrome
    Medical condition: Children with Down syndrom
    Disease: Version SOC Term Classification Code Term Level
    8.1 10013616 Down's syndrome LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-000687-16 Sponsor Protocol Number: ARIDDS2 Start Date*: 2017-12-13
    Sponsor Name:AOU FEDERICO II
    Full Title: Novel avenues for the rescue of intellectual disability in Down syndrome
    Medical condition: DOWN SYNDROME
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10042801 Syndrome Down's LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-008342-20 Sponsor Protocol Number: RAA08-015 Start Date*: 2009-02-23
    Sponsor Name:King's College London
    Full Title: Genetically determined brain abnormalities in Down’s Syndrome.- towards a treatment: A randomised, single-blind, placebo-controlled trial of lithium carbonate in Down’s Syndrome (DownsLit).
    Medical condition: Down's Syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10013616 Down's syndrome LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-001263-23 Sponsor Protocol Number: BP27832 Start Date*: 2014-03-19
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY OF THE EFFICACY, SAFETY AND TOLERABILITY OF RO5186582 IN ADULTS AND ADOLESCENTS WITH DOWN SYNDROME (CLEMATIS)
    Medical condition: Down Syndrome
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10044688 Trisomy 21 PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-001564-21 Sponsor Protocol Number: GN09CP301 Start Date*: 2011-09-19
    Sponsor Name:NHS Greater Glasgow and Clyde [...]
    1. NHS Greater Glasgow and Clyde
    2. University of Glasgow
    Full Title: Towards Onset Prevention of COGnitive decline in adults with Down syndrome (the TOP-COG study)
    Medical condition: Alzheimer's disease Down syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10001896 Alzheimer's disease LLT
    14.0 10010331 - Congenital, familial and genetic disorders 10013616 Down's syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-002613-34 Sponsor Protocol Number: NL76336.041.21 Start Date*: 2021-06-30
    Sponsor Name:University Medical Center Utrecht
    Full Title: Prospective monitoring of antibody response following COVID-19 vaccination in patients with Down Syndrome
    Medical condition: Persons with Down syndrome
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-003426-89 Sponsor Protocol Number: E2020-J081-345 Start Date*: 2018-10-18
    Sponsor Name:Eisai Co., Ltd. (Japan)
    Full Title: A Double-blind, Placebo-controlled Comparative Study and Open-label Extension Study to Confirm the Efficacy and Safety of E2020 in Subjects With Down Syndrome Having Regression Symptoms and Disable...
    Medical condition: Down syndrome, regression symptoms and disabled activities of daily living
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004947-35 Sponsor Protocol Number: E2020-A001-220 Start Date*: 2017-05-18
    Sponsor Name:Eisai Inc.
    Full Title: An Open-Label Study To Evaluate The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up T...
    Medical condition: Down Syndrome, Cognitive Dysfunction
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2004-000603-18 Sponsor Protocol Number: Q10DOWN Start Date*: 2004-06-11
    Sponsor Name:AZIENDA OSPEDALIERA UMBERTO I
    Full Title: ubiquinone in Down syndrome
    Medical condition: Down syndrome
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002988-25 Sponsor Protocol Number: ML-DS2018 Start Date*: Information not available in EudraCT
    Sponsor Name:Gesellschaft für Pädiatrische Onkologie & Hämatologie (GPOH gGmbH)
    Full Title: Phase III Clinical Trial for CPX-351 in Myeloid Leukemia in Children with Down Syndrome 2018
    Medical condition: Myeloid Leukemia in Children with Down Syndrome
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing) NL (Ongoing) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-004600-17 Sponsor Protocol Number: T21 Start Date*: Information not available in EudraCT
    Sponsor Name:Royal College of Surgeons in Ireland
    Full Title: The use of Sildenafil in Neonates with Down Syndrome to Reduce Pulmonary Vascular Resistance.
    Medical condition: to assess the impact of oral sildenafil administration on echocardiography measurements of pulmonary vascular resistance in neonates with Down Syndrome without Congenital Heart Disease.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10022891 - Investigations 10067285 Vascular resistance pulmonary increased PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-000381-39 Sponsor Protocol Number: KCL/DS/MEM/1 Start Date*: 2005-08-24
    Sponsor Name:King's College London
    Full Title: Efficacy and Safety of Memantine Hydrochloride, a low affinity antagonist to N-Methyl-D-Aspartate (NMDA) type receptors, in the prevention of cognitive decline and disease progression in older peop...
    Medical condition: Cognitive decline and dementia in Down's syndrome
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-004946-27 Sponsor Protocol Number: E2020-A001-219 Start Date*: 2017-05-18
    Sponsor Name:Eisai Inc.
    Full Title: A 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With D...
    Medical condition: Down Syndrome, Cognitive Dysfunction
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004949-92 Sponsor Protocol Number: E2020-A001-336 Start Date*: 2017-03-09
    Sponsor Name:Eisai Inc.
    Full Title: A 10-Week, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride (Aricept) in the Treatment of the Cognitive Dysfunction Exhibited by Children with...
    Medical condition: Down Syndrome, Cognitive Dysfunction
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004948-11 Sponsor Protocol Number: E2020-A001-335 Start Date*: 2017-03-09
    Sponsor Name:Eisai Inc.
    Full Title: A 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With D...
    Medical condition: Down Syndrome, Cognitive Dysfunction
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-002962-20 Sponsor Protocol Number: TMD01/2007 Start Date*: 2007-03-15
    Sponsor Name:Hannover Medical School
    Full Title: Elimination of the preleukemic clone in children with Down syndrome and transient myeloproloferative disorder (TMD) to prevent AML - Model of leukemia prevention
    Medical condition: Preleukemic clones have been frequently detected in newborns. The transient myeloproliferative disorder (TMD) represents a preleukemic clone. More than 20% of the patients developed acute megakaryo...
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-005780-16 Sponsor Protocol Number: 1042_OPBG_2016 Start Date*: 2019-04-10
    Sponsor Name:IRCCS Bambino Gesù Children's Hospital
    Full Title: A phase 2 controlled study with blinded outcome assessment on the efficacy of Bumetanide vs no drug treatment for cognitive improvement to rescue cognitive functions in children and adolescents wit...
    Medical condition: Down Syndrome
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-001556-11 Sponsor Protocol Number: 1058 Start Date*: 2011-05-23
    Sponsor Name:IRCCS FONDAZIONE STELLA MARIS
    Full Title: Decline of mentale functions in adults with Down Syndrome: clinical and experimental study on the effects of treatment with fluoxetine and of cognitive and physical training.
    Medical condition: Adults (over 30 years) with Down Syndrome.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10040442 Severe imbecility LLT
    14.1 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-001767-31 Sponsor Protocol Number: 101105 Start Date*: 2007-03-21
    Sponsor Name:University of Sheffield
    Full Title: Investigation of the effect of Interleukin-1 receptor antagonist (IL-1ra) on markers of inflammation in non-ST elevation acute coronary syndromes
    Medical condition: We wish to investigate Acute coronary syndromes (ACS). These are caused by blockages in the main arteries that supply the heart as a result of a process called atherosclerosis. These blockages pr...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10051592 Acute coronary syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (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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