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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   44394   clinical trials with a EudraCT protocol, of which   7406   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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    4,466 result(s) found. Displaying page 1 of 224.
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    EudraCT Number: 2010-020841-29 Sponsor Protocol Number: ADAPT Start Date*: 2011-07-07
    Sponsor Name:King`s College London [...]
    1. King`s College London
    2. Guy`s & St Thomas` NHS Foundation Trust
    Full Title: The role of anti-IgE (omalizumab) in the management of severe recalcitrant paediatric atopic eczema
    Medical condition: Severe eczema in children
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004858 10003641 Atopic eczema LLT
    19.0 100000004858 10014189 Eczema allergic atopic LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-004898-32 Sponsor Protocol Number: SAM103848 Start Date*: 2016-12-08
    Sponsor Name:GlaxoSmithKline Research & Development Ltd.
    Full Title: Pediatric Asthma Clinical Effectiveness study (PEACE). A Randomized, Double-Blind, Double Dummy, Parallel Group comparative clinical study of Salmeterol/Fluticasone propionate Inhalation Powder (50...
    Medical condition: Asthma
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-002109-20 Sponsor Protocol Number: AAV2-hRPE65v2-301 Start Date*: 2016-10-24
    Sponsor Name:Spark Therapeutics, Inc.
    Full Title: A Safety and Efficacy Study in Subjects with Leber Congenital Amaurosis (LCA) Using Adeno-Associated Viral Vector to Deliver the Gene for Human RPE65 to the Retinal Pigment Epithelium (RPE) [AAV2-h...
    Medical condition: Leber Congenital Amaurosis (LCA)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10070667 Leber's congenital amaurosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000263-32 Sponsor Protocol Number: V260-028 Start Date*: 2017-03-07
    Sponsor Name:Merck & Co., Inc.
    Full Title: A Double-Blind, Randomized, Placebo-Controlled, Safety and Tolerability Study of Live Pentavalent Human-Bovine Rotavirus Reassortant Vaccine in Chinese Healthy Adults, Children and Infants
    Medical condition: Prevention of Rotavirus Gastroenteritis Caused by Serotypes G1, G2, G3, G4, and G-Serotypes Associated With P1A [8] (e.g., G9) in Infants
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10039232 Rotavirus gastroenteritis LLT
    Population Age: Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002849-30 Sponsor Protocol Number: CCTL019B2101J/CHP-959 Start Date*: 2017-11-16
    Sponsor Name:University of Pennsylvania
    Full Title: A Phase I/IIA Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRzeta and 4-1BB Signaling Domains in Patients With Chemotherapy Resistant Or Refractory CD19+ Leuk...
    Medical condition: Chemotherapy resistant or refractory CD19+ B-cell Leukemia and Lymphoma.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10063621 Acute lymphoblastic leukaemia recurrent LLT
    20.0 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    20.0 10005329 - Blood and lymphatic system disorders 10025320 Lymphomas non-Hodgkin's B-cell HLGT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-005111-40 Sponsor Protocol Number: CN138-178 Start Date*: 2017-04-07
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc
    Full Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Flexible- Dosed Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents with Autistic Disorder
    Medical condition: Autistic Disorder
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000611-17 Sponsor Protocol Number: LTS12745 Start Date*: 2017-08-28
    Sponsor Name:Alfresa Pharma Corporation and Sanofi KK
    Full Title: A Long term study of M071754 - A open-label study in patients with infantile spasms.
    Medical condition: Patients diagnosed with infantile spasms
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10021750 Infantile spasms PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004680-39 Sponsor Protocol Number: AUTO3-PA1 Start Date*: 2017-06-21
    Sponsor Name:Autolus Limited
    Full Title: A Single Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO3, a CAR T Cell Treatment Targeting CD19 and CD22 in Paediatric and Adult Patients with R...
    Medical condition: Acute lymphoblastic leukaemia (ALL)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    20.0 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-004318-82 Sponsor Protocol Number: CTBM100CUS03 Start Date*: 2017-05-15
    Sponsor Name:Novartis Pharmaceuticals Corporation
    Full Title: Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    20.0 100000004862 10021860 Infection Pseudomonas aeruginosa LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003820-22 Sponsor Protocol Number: 2016-Longterm-OX Start Date*: 2016-12-22
    Sponsor Name:Dutch Growth Research Foundation
    Full Title: Intranasal administration of oxytocin in children with Prader-Willi Syndrome. A randomized, open-label, cross-over trial of different treatment regimens of oxytocin administration. Effects on eatin...
    Medical condition: Prader-Willi syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10036476 Prader-Willi syndrome PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Not Authorised)
    Trial results: (No results available)
    EudraCT Number: 2015-003537-99 Sponsor Protocol Number: ML28249 Start Date*: 2016-07-05
    Sponsor Name:F. Hoffmann-La Roche AG
    Full Title: A PHASE IV MULTICENTER, RANDOMIZED, OPEN LABEL, TWO-PERIOD CROSSOVER STUDY IN PATIENTS WITH CYSTIC FIBROSIS TO EVALUATE THE COMPARABLE EFFICACY AND SAFETY OF PULMOZYME® DELIVERED BY THE ERAPID™ NEB...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-005023-92 Sponsor Protocol Number: 4658-203 Start Date*: 2017-03-28
    Sponsor Name:Sarepta Therapeutics, Inc.
    Full Title: An Open-Label, Multi-Center Study to Evaluate the Safety, Efficacy and Tolerability of Eteplirsen in Early Stage Duchenne Muscular Dystrophy
    Medical condition: Patients with Duchenne Muscular Dystropy Amenable to Exon 51 Skipping
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-002613-30 Sponsor Protocol Number: GH-3899 Start Date*: 2016-04-25
    Sponsor Name:Novo Nordisk A/S
    Full Title: A 12-month, open-labelled, randomised, parallel-group, multi-centre, interventional trial to evaluate the efficacy and safety of recombinant human growth hormone (hGH) (Norditropin® Nordilet®) ther...
    Medical condition: Idiopathic short stature
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004859 10066333 Idiopathic short stature LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-003135-36 Sponsor Protocol Number: CYD67 Start Date*: 2019-10-31
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially with Gardasil® in Healthy Subjects Aged 9 to 13 Years in Malaysia
    Medical condition: Dengue Fever Dengue Hemorrhagic Fever Human Papillomavirus Disease
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004155-43 Sponsor Protocol Number: PA-CL-PED-01 Start Date*: 2016-05-04
    Sponsor Name:Vifor Fresenius Medical Care Renal Pharma France
    Full Title: An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and...
    Medical condition: Control of serum phosphorus levels in paediatric and adolescent subjects with chronic kidney disease (CKD).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004857 10076411 Chronic kidney disease stage 4 LLT
    20.0 100000004857 10076412 Chronic kidney disease stage 5 LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) DE (Prematurely Ended) PL (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-003536-12 Sponsor Protocol Number: CIGE025B1301E1 Start Date*: 2016-02-16
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: An Extension Study to CIGE025B1301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children (6 - 15 Years) With Inadequately Controlled Allergic Asthma Despite...
    Medical condition: Allergic Asthma
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002411-34 Sponsor Protocol Number: 20140315 Start Date*: 2019-01-28
    Sponsor Name:Amgen Inc.
    Full Title: Phase 3, Randomized, Open-label, Controlled, Multiple-Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 days to < 18 Years of age With Sec...
    Medical condition: Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10020708 Hyperparathyroidism secondary PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2015-003060-37 Sponsor Protocol Number: ANZUP1302 Start Date*: 2017-04-05
    Sponsor Name:Cambridge University Hospitals NHS Foundation Trust
    Full Title: UK P3BEP - A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours
    Medical condition: International germ cell classification catergory (IGCCC) intermediate or poor-risk metastatic germ cell tumours
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068971 Germ cell cancer metastatic PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-002252-27 Sponsor Protocol Number: TED-C14-006 Start Date*: 2016-09-19
    Sponsor Name:NPS Pharmaceuticals, Inc.
    Full Title: A 24-Week Double-blind, Safety, Efficacy, and Pharmacodynamic Study Investigating Two Doses of Teduglutide in Pediatric Subjects Through 17 Years of Age with Short Bowel Syndrome who are Dependent ...
    Medical condition: Short Bowel Syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) FI (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2017-002729-39 Sponsor Protocol Number: C-07-40 Start Date*: 2017-11-07
    Sponsor Name:Alcon Research Ltd
    Full Title: An Evaluation of the Safety and Efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% for the Treatment of Bacterial Conjunctivitis in the USA
    Medical condition: Bacterial conjunctivitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061784 Conjunctivitis bacterial PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly 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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