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Clinical trials for Pediatric Disorders

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   44346   clinical trials with a EudraCT protocol, of which   7374   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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    710 result(s) found for: Pediatric Disorders. Displaying page 8 of 36.
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    EudraCT Number: 2021-001337-40 Sponsor Protocol Number: BXCL501-105 Start Date*: 2021-10-05
    Sponsor Name:BioXcel Therapeutics, Inc.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DETERMINE EFFICACY AND SAFETY OF BXCL501 IN AGITATION ASSOCIATED WITH PEDIATRIC SCHIZOPHRENIA AND BIPOLAR DISORDER
    Medical condition: Subject that meets DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder, or other specified/unspecified schizophrenia spectrum and/or other psychotic disorders OR Subjec...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10039628 Schizophrenia and other psychotic disorders HLGT
    20.0 10037175 - Psychiatric disorders 10039629 Schizophrenia childhood LLT
    21.1 10037175 - Psychiatric disorders 10057667 Bipolar disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Restarted)
    Trial results: (No results available)
    EudraCT Number: 2010-021793-12 Sponsor Protocol Number: AC-052-374 Start Date*: 2011-04-04
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with p...
    Medical condition: Pulmonary arterial hypertension (PAH) in children
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004855 10064910 Familial (FPAH) LLT
    16.1 100000004855 10064909 Idiopathic (IPAH) LLT
    16.1 100000004855 10064908 Associated with (APAH) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) CZ (Completed) FR (Ongoing) NL (Completed) ES (Completed) IT (Completed) PL (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-000811-29 Sponsor Protocol Number: I6T-MC-AMAY Start Date*: 2023-08-16
    Sponsor Name:Eli Lilly and Company
    Full Title: A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn’s Disease (MACARONI-23)
    Medical condition: Clinical Study to Evaluate Mirikizumab in Pediatric Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned) FR (Trial now transitioned) AT (Trial now transitioned) PT (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003053-42 Sponsor Protocol Number: CNTO1959PSO3011 Start Date*: 2018-09-04
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics (PK) of Subcutaneously Administered Guselkumab for the Trea...
    Medical condition: Chronic Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) DE (Trial now transitioned) NL (Ongoing) PL (Trial now transitioned) HU (Trial now transitioned) Outside EU/EEA IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-003453-16 Sponsor Protocol Number: SHP677-304 Start Date*: 2019-07-31
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRIC AND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD)
    Medical condition: severe von Willebrand Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed) DE (Completed) ES (Completed) AT (Completed) IT (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-001465-24 Sponsor Protocol Number: GC-LTFU-001 Start Date*: 2018-02-26
    Sponsor Name:Celgene Corporation
    Full Title: Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells.
    Medical condition: Defined by parent protocol. The study will enroll all adult and paediatric subjects who received at least one genetically modified T cells infusion in a previous Celgene sponsored study.
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10025631 Malignant lymphoid neoplasm NOS LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) DE (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) AT (Trial now transitioned) FR (Trial now transitioned) FI (Trial now transitioned) SE (Trial now transitioned) GB (GB - no longer in EU/EEA) NO (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-005789-42 Sponsor Protocol Number: TDR14311 Start Date*: 2016-08-02
    Sponsor Name:SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    Full Title: Randomized, Double-blind, Placebo-controlled, Dose escalation, Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients with Type 2 Diabetes Mellitus Not Adequat...
    Medical condition: Pediatric Patients with Type 2 Diabetes Mellitus Not Adequately Controlled with Metformin and/or Basal Insulin
    Disease: Version SOC Term Classification Code Term Level
    19.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-005311-49 Sponsor Protocol Number: I6T-MC-AMAZ Start Date*: 2022-11-09
    Sponsor Name:ELI LILLY & COMPANY, LILLY CORPORATE CENTER
    Full Title: Master protocol for a Phase 3, multicenter, open-label, long-term extension study to evaluate the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ul...
    Medical condition: - Crohn´s Disease. - Moderately to severely active Ulcerative Colitis.
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004381-19 Sponsor Protocol Number: NBI-74788-CAH2006 Start Date*: 2021-06-07
    Sponsor Name:Neurocrine Biosciences, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects with Classic Congenital Adrenal Hyperplasia, Followed by O...
    Medical condition: Classic Congenital Adrenal Hyperplasia (CAH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010323 Congenital adrenal hyperplasia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GR (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-000651-16 Sponsor Protocol Number: 0869-208 Start Date*: 2011-07-20
    Sponsor Name:Merck Sharp & Dohme (Sweden) AB
    Full Title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of Aprepitant for the Prevention...
    Medical condition: Pediatric Chemotherapy induced nausea and vomiting (CINV)
    Disease: Version SOC Term Classification Code Term Level
    13.1 10017947 - Gastrointestinal disorders 10052401 Vomiting post chemotherapy LLT
    13.1 10017947 - Gastrointestinal disorders 10056989 Nausea post chemotherapy LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) PT (Not Authorised) LT (Completed) ES (Completed) NL (Completed) DK (Completed) HU (Completed) SI (Completed) GR (Completed) GB (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-005237-30 Sponsor Protocol Number: REMICADEPIB4002 Start Date*: 2009-12-01
    Sponsor Name:Janssen Biologics B.V.
    Full Title: A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis
    Medical condition: Pediatric patients with a confirmed diagnosis of CD or UC .
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004856 10013099 Disease Crohns LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-003964-18 Sponsor Protocol Number: CV181-153 Start Date*: 2014-10-02
    Sponsor Name:Bristol-Myers Squibb Company
    Full Title: Evaluation of the Pharmacokinetics of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin in Children and Adolescents Aged 10 to 17 Years with Type 2 Diabetes Mellitus Following Oral Administration o...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    17.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: Removed from public view
    EudraCT Number: 2021-000630-34 Sponsor Protocol Number: MLN0002-3029 Start Date*: 2022-12-09
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease
    Medical condition: Active Ulcerative Colitis (UC) or Crohn's disease (CD)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) PL (Trial now transitioned) CZ (Prematurely Ended) ES (Prematurely Ended) SK (Prematurely Ended) GR (Trial now transitioned) BE (Trial now transitioned) LT (Completed) HR (Trial now transitioned) Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2010-020310-28 Sponsor Protocol Number: C10-003 Start Date*: 2011-07-07
    Sponsor Name:ALEXION PHARMACEUTICALS, INC.
    Full Title: AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS)
    Medical condition: Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10019515 Hemolytic uremic syndrome LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) GB (Completed) FR (Completed) AT (Completed) IT (Completed) BE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-005003-24 Sponsor Protocol Number: 109MS202 Start Date*: 2015-06-01
    Sponsor Name:Biogen Idec Research Limited
    Full Title: Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years
    Medical condition: Relapsing-Remitting Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    17.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LV (Completed) DE (Completed) CZ (Completed) BG (Completed) PL (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023206-12 Sponsor Protocol Number: FARM6HCEM5 Start Date*: 2008-09-26
    Sponsor Name:AZIENDA OSPEDALIERA VINCENZO MONALDI DI NAPOLI
    Full Title: Arterial Hypertension After Successful Aortic Decoarctation: Atenolol vs Enalapril Comparison of Efficacy and Tolerability in Pediatric Age.
    Medical condition: Aortic coarctation and hypertensive patients
    Disease: Version SOC Term Classification Code Term Level
    9.1 10007541 SOC
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-002349-36 Sponsor Protocol Number: 0462-107 Start Date*: 2011-06-30
    Sponsor Name:Merck & Co., Inc.
    Full Title: An Open-Label Single-Dose Study to Evaluate the Pediatric Palatability of Maxalt Oral Disintegrating Tablets
    Medical condition: Migraine
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10027599 Migraine PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-020852-79 Sponsor Protocol Number: A0081041 Start Date*: 2011-08-24
    Sponsor Name:Pfizer Inc.235 East 42nd Street, New York, NY 10017
    Full Title: A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 4 -16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES
    Medical condition: Partial onset seizures
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004852 10034089 Partial seizures NOS LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) LT (Prematurely Ended) FI (Completed) NL (Completed) FR (Ongoing) HU (Completed) BE (Completed) EE (Completed) SE (Completed) PL (Completed) AT (Completed) GR (Completed) IT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2017-003770-14 Sponsor Protocol Number: 3030-202-002 Start Date*: 2018-10-11
    Sponsor Name:Allergan LTD
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Eluxadoline in Pediatric Patients (Age 12 to 17 Years) with Irrit...
    Medical condition: Irritable Bowel Syndrome with Diarrhea (IBS-D)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10023003 Irritable bowel syndrome PT
    20.1 10017947 - Gastrointestinal disorders 10060845 Diarrhea predominant irritable bowel syndrome LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Prematurely Ended) HU (Completed) NL (Completed) DE (Prematurely Ended) PL (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-005732-18 Sponsor Protocol Number: DU176b-A-U157 Start Date*: 2016-06-29
    Sponsor Name:Daiichi Sankyo , Inc.
    Full Title: A Phase 1, Open-Label, Single-dose, Non-randomized Study to Evaluate Pharmacokinetics and Pharmacodynamics of Edoxaban in Pediatric Patients
    Medical condition: Edoxaban is being investigated for use in pediatric patients who may require anticoagulation therapy.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10010495 Congenital heart disease NOS LLT
    19.0 100000004851 10057396 Thrombophilia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) FR (Ongoing) IT (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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