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Clinical trials for Trisomy 21

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   44341   clinical trials with a EudraCT protocol, of which   7370   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    18 result(s) found for: Trisomy 21. Displaying page 1 of 1.
    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: 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: 2005-000309-75 Sponsor Protocol Number: Start Date*: 2005-08-26
    Sponsor Name:Christian Geisler, Rigshospitalet, dept. Haematology 4042
    Full Title: HOVON 68 CLL: A randomized phase III study in prevously untreated patients with biological high risk CLL: Fludarabine + cyclophosphamide (FC) versus FC + low-dose alemtuzumab.
    Medical condition: Chronic lymphocytic leukaemia (CLL) in biological high-risk group: Unmutated and/or with deletion 17p and/or deletion 11q and/or trisomy 12.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) SE (Ongoing) FI (Completed) BE (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-001936-45 Sponsor Protocol Number: matab4 Start Date*: 2011-05-25
    Sponsor Name:
    Full Title: Pertussis vaccination in pregnancy
    Medical condition: The number of reported pertussis cases is rising, also in very young infants. Different strategies are possible to close the gap of susceptibility between the loss of maternal antibodies and prote...
    Disease:
    Population Age: In utero, Newborns, Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    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: 2016-003181-12 Sponsor Protocol Number: HOTPOT1 Start Date*: 2016-10-07
    Sponsor Name:Royal College of Surgeons in Ireland
    Full Title: Can sonographic assessment of pulmonary vascular reactivity following maternal hyperoxygenation therapy predict neonatal outcome in fetuses at risk of pulmonary hypertension?
    Medical condition: Persistent pulmonary hypertension of the newborn (PPHN) is a relatively common condition occurring in 7/1000 births and can result in significant cardiovascular instability in the newborn. It occur...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: IE (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: 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: 2006-001853-89 Sponsor Protocol Number: CLI-043 Start Date*: 2006-07-07
    Sponsor Name:Vion Pharmaceuticals, Inc
    Full Title: A phase II study of Cloretazine for elderly patients with de novo poor risk acute myelogenous leukemia.
    Medical condition: Acute Myelogenous Leukemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: (No results available)
    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: 2020-005996-11 Sponsor Protocol Number: MK-1654-007 Start Date*: 2021-08-26
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for S...
    Medical condition: Prevention of Respiratory syncytial virus (RSV) infection in infants and children at increased risk for severe RSV disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10066742 Respiratory syncytial virus infection prophylaxis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Trial now transitioned) DE (Trial now transitioned) FI (Trial now transitioned) Outside EU/EEA HU (Trial now transitioned) FR (Trial now transitioned) NO (Trial now transitioned) GR (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-002714-23 Sponsor Protocol Number: LLC1114 Start Date*: 2015-01-07
    Sponsor Name:Fondazione G.I.M.EM.A. Onlus Gruppo Italiano Malattie Ematologiche dell'Adulto
    Full Title: A phase 2 multicenter study to assess the activity and the safety of front-line Ibrutinib plus Rituximab (IR) in unfit patients with Chronic Lymphocytic Leukemia (CLL).
    Medical condition: Chronic Lymphocytic Leukemia
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004864 10024340 Leukemia lymphocytic chronic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    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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