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Clinical trials

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   44336   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    7,366 result(s) found. Displaying page 196 of 369.
    EudraCT Number: 2021-000190-81 Sponsor Protocol Number: TIPP Start Date*: 2021-12-29
    Sponsor Name:Goethe-University Frankfurt
    Full Title: A prospective multicenter placebo-controlled trial to study the efficacy and safety of Tiotropium in preventing severe asthma exacerbations in partial and uncontrolled preschool asthma. TIPP-Study
    Medical condition: Severe asthma exacerbations in partial and uncontrolled preschool asthma
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2020-001521-31 Sponsor Protocol Number: D5982C00008 Start Date*: 2021-04-20
    Sponsor Name:AstraZeneca AB
    Full Title: A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter 24 to 52 Week Variable Length Study to Assess the Efficacy and Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate Me...
    Medical condition: Severe and inadequately controlled asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Trial now transitioned) DE (Trial now transitioned) CZ (Trial now transitioned) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001978-22 Sponsor Protocol Number: I17004 Start Date*: 2019-07-31
    Sponsor Name:CHU de LIMOGES
    Full Title: Injections of Sodium Thiosulfate for ectopic calcifications or ossifications. A pilot study.
    Medical condition: Patient presenting with: - ectopic ossification secondary to iPPSD2 or - ectopic calcification secondary to dermatomyositis or - ectopic calcification secondary to systemic sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004867 10006935 Calcification and ossification, unspecified LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-002477-38 Sponsor Protocol Number: P140929 Start Date*: Information not available in EudraCT
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10000686 Acute bronchiolitis LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-005786-14 Sponsor Protocol Number: 7830 Start Date*: 2021-10-13
    Sponsor Name:Hôpitaux Universitaires de Strasbourg B.1.2
    Full Title: A randomized and controlled phase II national protocol in non NF1 pediatric and AYA (Adolescent and Young Adults) patients bearing a wild type BRAF gene newly diagnosed comparing a daily oral MEK i...
    Medical condition: Histologically proven grade 1 glioma/mixed glio-neuronal tumors or pleomorphic xanthoastrocytoma (PXA) confirmed
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2023-000884-30 Sponsor Protocol Number: mRNA-1283-P301 Start Date*: 2024-03-28
    Sponsor Name: ModernaTX, Inc.
    Full Title: A Randomized, Observer-Blind, Active-Controlled Phase 3 Study to Investigate the Safety, Immunogenicity, and Relative Vaccine Efficacy of mRNA-1283 Compared with mRNA-1273 in Participants Aged ≥ 12...
    Medical condition: COVID-19
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2018-003335-29 Sponsor Protocol Number: SIOPEATRT01 Start Date*: 2021-04-15
    Sponsor Name:German Pediatric Oncology Group, GPOH gGmbH
    Full Title: An international prospective umbrella trial for children with atypical teratoid/rhabdoid tumours (ATRT) including A randomized phase III study evaluating the non-inferiority of three courses of hig...
    Medical condition: atypical teratoid/rhabdoid tumours (ATRT)
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing) NO (Trial now transitioned) NL (Trial now transitioned) DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001147-51 Sponsor Protocol Number: COMPIS Start Date*: 2020-03-31
    Sponsor Name:Västra götalandsregionen
    Full Title: Congenital myopathy intervention study
    Medical condition: Congenital myopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10062547 Congenital myopathy PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-000424-86 Sponsor Protocol Number: Start Date*: 2008-11-25
    Sponsor Name:Erasmus MC
    Full Title: Development and introduction of a pediatric liquid formulation of 6-mercaptopurine for treatment of leukemia
    Medical condition: Acute lymphoblastic leukemia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2021-003398-79 Sponsor Protocol Number: MH21HEM Start Date*: 2023-05-11
    Sponsor Name:Princess Máxima Center for pediatric oncology
    Full Title: International proof of concept therapeutic Stratification trial of Molecular Anomalies in Relapsed or Refractory HEMatological malignancies in children Subprotocol D: Trametinib + Dexamethasone + C...
    Medical condition: Molecularly profiled r/r ALL/LBL whose tumor harbors an actionable event that can be targeted by the investigational agents. In this subprotocol, patients must present alterations in the RAS signal...
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000241-32 Sponsor Protocol Number: NL80290.018.22 Start Date*: 2022-08-08
    Sponsor Name:Amsterdam UMC
    Full Title: Effectiveness of L-serine dietary supplementation in children with a GRIN2B loss-of-function mutation: n-of-1 series
    Medical condition: GRIN2B deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10027424 Metabolic and nutritional disorders congenital HLGT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002098-86 Sponsor Protocol Number: BOFT-0520/PED Start Date*: Information not available in EudraCT
    Sponsor Name:FAES FARMA, S.A.
    Full Title: Multi-centre, randomised, double blind, placebo-controlled, parallel, phase III study to assess the safety, tolerability and efficacy of Bilastine ophthalmic solution 0.6% in children
    Medical condition: Allergic conjunctivitis (AC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10001709 Allergic conjunctivitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2022-003572-16 Sponsor Protocol Number: TAK-633-3008 Start Date*: 2022-12-06
    Sponsor Name:Takeda
    Full Title: A Phase 3, Open-label Safety Study of Teduglutide in Japanese Pediatric Patients With Short Bowel Syndrome Who are Dependent on Parenteral Support, Aged 4 Months of Corrected Gestational Age or Old...
    Medical condition: Short Bowel Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-005097-25 Sponsor Protocol Number: KIDS-STEP Start Date*: Information not available in EudraCT
    Sponsor Name:Universitätskinderspital beider Basel (UKBB)
    Full Title: A randomised placebo-controlled multi-centre effectiveness trial of adjunct betamethasone therapy in hospitalised children with community acquired pneumonia (CAP)
    Medical condition: Children with community acquired pneumonia (CAP).
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002863-24 Sponsor Protocol Number: 65364 Start Date*: 2019-01-11
    Sponsor Name:Erasmus MC
    Full Title: Intralesional steroid injections to prevent refractory strictures in patinets with esophageal atresia - a randomized controlled trial
    Medical condition: Recurrent stenosis after correction of esophageal atresia
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) FI (Trial now transitioned) FR (Trial now transitioned) DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-004893-26 Sponsor Protocol Number: D6992C00044 Start Date*: 2007-05-03
    Sponsor Name:AstraZeneca AB
    Full Title: An open-label, non-comparative trial to evaluate the safety, efficacy and pharmacokinetics of FASLODEX (fulvestrant) in girls with progressive precocious puberty associated with McCune-Albright Syn...
    Medical condition: Progressive precocious puberty associated with McCune-Albright Syndrome
    Disease:
    Population Age: Children, Under 18 Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-001968-33 Sponsor Protocol Number: P171006J Start Date*: 2019-01-16
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Étude ouverte de phase 1/2 évaluant la sécurité et l’efficacité de l’injection de cellules CD34 + autologues transduites ex vivo par le vecteur lentiviral GLOBE1 qui exprime le gène de la globi...
    Medical condition: Patients with Sickle Cell disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10040644 Sickle cell disease LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-004287-98 Sponsor Protocol Number: TCD17197 Start Date*: 2022-03-16
    Sponsor Name:Sanofi-Aventis Recherche & Developpement
    Full Title: An open-label, first-in-human, dose-escalation/expansion study of SAR443579 administered as single agent by intravenous infusion in patients with relapsed or refractory acute myeloid leukemia (R/R ...
    Medical condition: Relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplasia (HR-MDS)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10003917 B-cell type acute leukaemia PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10081513 Acute myeloid leukaemia refractory PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-003778-30 Sponsor Protocol Number: DRO-200/III/21/1 Start Date*: 2021-12-29
    Sponsor Name:Drossapharm AG
    Full Title: Randomized, controlled, multi-center trial to evaluate the efficacy and safety of Lixim 70 mg wirkstoffhaltiges Pflaster (etofenamate 70 mg medicated plaster) vs. placebo in the local symptomatic a...
    Medical condition: Acute strains, sprains or bruises of soft tissues following blunt trauma, e.g. sports injuries
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-000926-23 Sponsor Protocol Number: B1851178 Start Date*: 2024-03-07
    Sponsor Name:Pfizer, Inc.
    Full Title: A PHASE 3 OPEN-LABEL TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN INFANTS AND YOUNG CHILDREN IN CHINA WHO ARE NAIVE TO PNEUMOCOCCAL V...
    Medical condition: Pneumococcal Infections
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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