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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   44381   clinical trials with a EudraCT protocol, of which   7393   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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    7,393 result(s) found. Displaying page 196 of 370.
    EudraCT Number: 2022-004131-61 Sponsor Protocol Number: M16-904 Start Date*: 2023-04-18
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children with Ce...
    Medical condition: Central Precocious Puberty
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-000956-12 Sponsor Protocol Number: 277HV101 Start Date*: Information not available in EudraCT
    Sponsor Name:Biogen Idec Research Limited
    Full Title: A Randomized, Blinded, Placebo-Controlled, Phase 1 Single Ascending Dose Study in Healthy Adult Male Volunteers and an Open-Label Multiple Ascending Dose Study in Pediatric SMA Participants Previou...
    Medical condition: Spinal muscular atrophy
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10041582 Spinal muscular atrophy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) DE (Ongoing) PT (Prematurely Ended) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-001429-16 Sponsor Protocol Number: HORA-PDE6B-001 Start Date*: 2017-07-28
    Sponsor Name:HORAMA SA
    Full Title: Safety and Efficacy of a Unilateral Subretinal Administration of HORA-PDE6B in Patients Harboring Mutations in the PDE6B Gene Leading to a Defect in PDE6B Expression.
    Medical condition: Retinitis Pigmentosa
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-006088-61 Sponsor Protocol Number: I8R-MC-IGBO Start Date*: 2024-03-05
    Sponsor Name:Eli Lilly and Company
    Full Title: An Open-Label, Multi-Center, Single-Dose Study to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Nasal Glucagon in Pediatric Patients with Type 1 Diabetes Aged 1 to <4 y...
    Medical condition: severe hypoglycemia
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-002997-35 Sponsor Protocol Number: OVG2014/05 Start Date*: 2015-02-06
    Sponsor Name:University of Oxford
    Full Title: A phase III multi-centre randomised, double blind, placebo controlled trial to assess the role of intravenous immunoglobulin in the management of children with encephalitis (The IgNiTE study)
    Medical condition: Encephalitis
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004862 10014594 Encephalitis infection LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2018-000566-11 Sponsor Protocol Number: 39-2018 Start Date*: 2018-06-05
    Sponsor Name:University of Oulu
    Full Title: Extremely low gestational age infants' PARAcetamol Study
    Medical condition: Open ductus arteriosus of a premature infant
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001189-13 Sponsor Protocol Number: C4181005 Start Date*: 2021-02-26
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 2 MULTIPLE DOSE, RANDOMIZED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA
    Medical condition: Achondroplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10000452 Achondroplasia LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: PT (Prematurely Ended) DK (Prematurely Ended) BE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-004187-35 Sponsor Protocol Number: FACE-01 Start Date*: Information not available in EudraCT
    Sponsor Name:Falun Hospital
    Full Title: The FACE (Facial nerve palsy And Cortisone Evaluation) study in children: a randomised double-blind, placebo-controlled, multicenter trial.
    Medical condition: Facial Nerve Palsy (Bells Palsy)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004852 10077335 Facial nerve paresis LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2023-001064-26 Sponsor Protocol Number: TMC278LAHTX4002 Start Date*: 2024-05-24
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 4, Open-Label, Rollover Study to Provide Continued Access to Cabotegravir Long-acting Injection and Rilpivirine Long-acting Injection to Participants Living with Human Immunodeficiency Viru...
    Medical condition: Human Immunodeficiency Virus 1
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10020443 Human immunodeficiency virus syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2022-003221-22 Sponsor Protocol Number: TAK-555-3010 Start Date*: 2024-01-15
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: Phase 3, Multicenter, Randomized Study With 2 Different Doses of Prucalopride Administered to Male and Female Pediatric Subjects Aged 6 Months to 17 Years With Functional Constipation, Consisting o...
    Medical condition: Constipation
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2024-000165-25 Sponsor Protocol Number: mRNA-1273-P306 Start Date*: 2024-05-30
    Sponsor Name:ModernaTX, Inc.
    Full Title: An Open-Label, Phase 3 Study to Evaluate the Safety and Immunogenicity of mRNA Vaccines for SARS-CoV-2 Variants in Participants Aged 6 Months to <6 Years
    Medical condition: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2021-001425-48 Sponsor Protocol Number: BLUEBERRY Start Date*: 2021-07-07
    Sponsor Name:Division of Anaesthesiology - Department of Acute Medicine - Geneva Children's Hospital, University Hospitals of Geneva
    Full Title: Dexamethasone and postoperative bleeding following tonsillectomy in children
    Medical condition: Tonsillectomy/tonsillotomy
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-001443-52 Sponsor Protocol Number: LLB-2019-02 Start Date*: 2019-11-13
    Sponsor Name:LABO'LIFE Belgium sprl
    Full Title: Randomized study to evaluate 2LVERU® JUNIOR and 2LVERU® efficacy on the treatment of warts. Protocol EVAsION
    Medical condition: Non genital warts infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10035150 Planar warts LLT
    20.0 100000004864 10035158 Plantar warts LLT
    20.0 100000004864 10047828 Warts LLT
    21.1 100000004864 10010115 Common warts LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2023-000944-46 Sponsor Protocol Number: 217218 Start Date*: 2024-05-31
    Sponsor Name:GLAXOSMITHKLINE BIOLOGICALS SA
    Full Title: A Phase IIa observer-blind, randomized, controlled, age-de-escalation, single center interventional study to evaluate the safety, reactogenicity, and immune response of the GVGH iNTS vaccine agains...
    Medical condition: Prevention of invasive nontyphoidal Salmonella disease
    Disease:
    Population Age: Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2019-005039-94 Sponsor Protocol Number: IC2019-05 Start Date*: 2020-12-08
    Sponsor Name:Institut Curie
    Full Title: RETINO 2018 : Ocular conservative treatment for retinoblastoma: efficacy of the new management strategies and visual outcome.
    Medical condition: Retinoblastoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2024-000202-16 Sponsor Protocol Number: MLB-01-003 Start Date*: 2024-05-31
    Sponsor Name:ML Bio Solutions
    Full Title: AN OPEN LABEL PHASE 2 STUDY OF BBP 418 IN PATIENTS WITH LIMB GIRDLE MUSCULAR DYSTROPHY TYPE 2I (MLB 01 003)
    Medical condition: Limb Girdle Muscular Dystrophy 2I/R9
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2020-000085-42 Sponsor Protocol Number: LLB-2019-03 Start Date*: Information not available in EudraCT
    Sponsor Name:LABO'LIFE Belgium sprl
    Full Title: Randomized, placebo-controlled, double blind study to evaluate the efficacy of 2LEBV® and 2LXFS® on asthenia in patients with an EBV infection. EBVAST Study
    Medical condition: Epstein-Barr Virus infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10014077 EBV infection LLT
    23.0 100000004862 10014078 EBV infection reactivation LLT
    21.1 100000004848 10056906 EBV antibody positive LLT
    21.0 100000004848 10056907 EBV antigen positive LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000063-51 Sponsor Protocol Number: mRNA-1273-P305 Start Date*: 2024-01-01
    Sponsor Name:ModernaTX, Inc.
    Full Title: A Phase 2/3, Randomized, Observer-blind, Active-controlled, Multicenter Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison with mRNA-1273 (Prototype) Booster ...
    Medical condition: SARS-CoV-2
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-002927-14 Sponsor Protocol Number: AGO/2012/004 Start Date*: 2013-07-10
    Sponsor Name:University Ghent
    Full Title: Dosistitratie van lisinopril bij kinderen van 1 tot 18 jaar met primaire of secundaire hypertensie
    Medical condition: Hypertensie
    Disease: Version SOC Term Classification Code Term Level
    14.1 10047065 - Vascular disorders 10020781 Hypertension malignant LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023168-41 Sponsor Protocol Number: 1248.6 Start Date*: 2011-10-17
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG,
    Full Title: A randomised, double-blind, double-dummy, placebo-controlled, parallel-group study to assess and compare efficacy and safety of an 8-week treatment with BI 54903 at doses of 45.5, 90.9 and 181.8 μg...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003561 Asthma, unspecified LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BG (Completed) FR (Ongoing) SK (Prematurely Ended)
    Trial results: View results
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
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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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