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Clinical trials for Early childhood

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   44365   clinical trials with a EudraCT protocol, of which   7389   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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    104 result(s) found for: Early childhood. Displaying page 1 of 6.
    1  2  3  4  5  6  Next»
    EudraCT Number: 2007-000576-16 Sponsor Protocol Number: R076477PSZ3001 Start Date*: 2012-03-09
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Randomized, Multicenter, Double-Blind, Weight-Based, Fixed-Dose, Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of Extended Release Paliperidone for the Treatment of Schizo...
    Medical condition: Adolescent Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10008525 Childhood schizophrenia LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-000210-19 Sponsor Protocol Number: CRIT124D2302E1 Start Date*: 2011-06-10
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 6-month, open-label extension to a 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of Ritalin® LA in the treatment of adult patients with childhood-on...
    Medical condition: Adult patients with childhood-onset Attention Deficit Hyperactivity Disorder
    Disease: Version SOC Term Classification Code Term Level
    14.0 10037175 - Psychiatric disorders 10003735 Attention deficit-hyperactivity disorder LLT
    14.0 10037175 - Psychiatric disorders 10003737 Attention deficit/hyperactivity disorder NOS LLT
    14.0 10037175 - Psychiatric disorders 10003736 Attention deficit/hyperactivity disorder PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) BE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2010-021979-85 Sponsor Protocol Number: 2009-323 Start Date*: 2017-06-01
    Sponsor Name:The Pediatric Clinics, The Juliane Marie Center, The Danish National Hospital "Rigshospitalet"
    Full Title: Danish: BCG vaccination og sygelighed blandt danske småbørn. En prospektivt, randomiseret, klinisk lægemiddelafprøvning. English: Bacille Calmette Guérin immunisation at birth and childhood morbidi...
    Medical condition: The study aims to test the hypothesis of the positive non-specific effect of BCG immunization at birth on early childhood morbidity in a high-income country.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10054112 Hospitalisation LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2016-002875-81 Sponsor Protocol Number: NL58621.041.16 Start Date*: 2016-10-19
    Sponsor Name:UMC Utrecht
    Full Title: Bumetanide for the Autism Spectrum Clinical Effectiveness Trial
    Medical condition: Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10008520 Childhood autism LLT
    20.0 10037175 - Psychiatric disorders 10063844 Autism spectrum disorder PT
    20.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    20.0 10037175 - Psychiatric disorders 10061345 Pervasive developmental disorder LLT
    20.0 10037175 - Psychiatric disorders 10003805 Autism LLT
    20.0 10037175 - Psychiatric disorders 10034739 Pervasive developmental disorder NOS LLT
    20.0 10037175 - Psychiatric disorders 10064104 ADHD LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-018161-12 Sponsor Protocol Number: SPD503-315 Start Date*: 2010-12-23
    Sponsor Name:Shire Development Inc
    Full Title: A Phase 3, Double-blind, Placebo-controlled, Multicentre, Randomised withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adol...
    Medical condition: Attention-Deficit/Hyperactive Disorder (ADHD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004873 10068451 ADHD, combined type LLT
    14.1 100000004873 10068453 ADHD, predominantly inattentive type LLT
    14.1 100000004873 10068452 ADHD, predominantly hyperactive-impulsive type LLT
    14.1 100000004873 10064104 ADHD LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) NL (Completed) ES (Completed) SE (Completed) BE (Completed) IT (Completed)
    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: 2008-007236-18 Sponsor Protocol Number: 1484/08 Start Date*: 2008-12-01
    Sponsor Name:POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    Full Title: Effects of cardioprotective therapy, carvedilol vs ramipril, in patients affected by Duchenne and Becker muscular dystrophy. Clinical significance and prognostic value of Cardiac Magnetic Resonance...
    Medical condition: Duchenne and Becher muscular dystrophy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013801 Duchenne muscular dystrophy LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-000106-11 Sponsor Protocol Number: I14039 Start Date*: 2016-04-18
    Sponsor Name:Limoges Hospital
    Full Title: EVALUATION OF THE EFFICIENCY OF TREATMENT BY BUMETANIDE ON AUTISTIC CHILDREN WITH A KNOWN ETIOLOGY: MULTICENTER AND DOUBLE-BLIND STUDY WITH RANDOMIZED PARALLEL GROUP, AGAINST PLACEBO.
    Medical condition: autism
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029205 - Nervous system disorders 10003805 Autism PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-002274-31 Sponsor Protocol Number: U1111-1215-8606 Start Date*: 2020-12-16
    Sponsor Name:Department of Biomedical Sciences, University of Copenhagen
    Full Title: Young adults with early-onset obesity treated with semaglutide
    Medical condition: Obesity
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10029885 Obesity, unspecified LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-002985-22 Sponsor Protocol Number: TFS01 Start Date*: 2015-11-18
    Sponsor Name:Mika J. Mäkelä
    Full Title: Efficacy of Intermittent Tiotropium in Early Childhood Wheezing
    Medical condition: Early childhood wheezing
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004855 10047921 Wheeze LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2015-001042-28 Sponsor Protocol Number: CONCERTAATT4080 Start Date*: 2015-04-24
    Sponsor Name:Ortho-McNeil Janssen Scientific Affairs LLC
    Full Title: Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral and Cognitive Effects of CONCERTA on Older Children with ADHD (The ABC Study)
    Medical condition: Attention Deficit Hyperactivity Disorder
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004873 10003735 Attention deficit-hyperactivity disorder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001081-26 Sponsor Protocol Number: CONCERTAATT4069 Start Date*: 2015-04-24
    Sponsor Name:Ortho-McNeil Janssen Scientific Affairs LLC
    Full Title: The ABC Study: A Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral, and Cognitive Effects of CONCERTA on Older Children with ADHD
    Medical condition: Attention Deficit Hyperactivity Disorder
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004873 10003735 Attention deficit-hyperactivity disorder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-010393-38 Sponsor Protocol Number: RB 09.017 Start Date*: 2009-12-04
    Sponsor Name:CHU de BREST
    Full Title: ETUDE DE L’EFFICACITE D’UN TRAITEMENT PAR BUMETANIDE DANS UNE POPULATION D’ENFANTS AUTISTES
    Medical condition: Autisme
    Disease: Version SOC Term Classification Code Term Level
    12.0 10003806 Autism infantile LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-003750-89 Sponsor Protocol Number: KKS-186 Start Date*: 2013-02-14
    Sponsor Name:Philipps-University Marburg
    Full Title: A placebo-controlled, double blind, randomised trial with crossover-design investigating the effect of oxytocin nasal spray on neuronal processes of empathy
    Medical condition: high-functioning autism spectrum disorders: autistic disorder (F84.0), Asperger syndrome (F84.5), atypical autism (F 84.1)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004852 10021737 Infantile autism LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-001220-31 Sponsor Protocol Number: RISAUT4002 Start Date*: 2015-03-31
    Sponsor Name:Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
    Full Title: Risperidone in the Treatment of Children and Adolescents With Autistic Disorder: A Double-Blind, Placebo-Controlled Study of Efficacy and Safety, Followed by an Open-Label Extension Study of Safety
    Medical condition: Autistic disorder
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004852 10003808 Autistic disorder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-000586-45 Sponsor Protocol Number: S56327 Start Date*: 2014-05-08
    Sponsor Name:KU Leuven
    Full Title: Oxytocin-based pharmacotherapy for Autism Spectrum Disorders: Investigating the neural and behavioral effects of a promising intervention approach
    Medical condition: Young male adults with Autism Spectrum Disorders (18-30 years)
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004852 10003808 Autistic disorder LLT
    Population Age: Adults Gender: Male
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2008-001689-97 Sponsor Protocol Number: LOC/07-11 Start Date*: 2009-12-11
    Sponsor Name:CHU de Rennes
    Full Title: Etude de la relation dose-effet de la mélatonine dans l'autisme infantile.
    Medical condition: Autisme infantile, notamment les troubles du sommeil et de la communication
    Disease: Version SOC Term Classification Code Term Level
    12.0 10003805 Autism LLT
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-003067-59 Sponsor Protocol Number: AOB/2013/01 Start Date*: 2017-01-25
    Sponsor Name:AZIENDA OSPEDALIERA G. BROTZU
    Full Title: A single-center, randomized, double-blind, placebo-controlled, cross-over study of intranasal oxytocin in young adults with Autism Spectrum Disorder
    Medical condition: Autism Spectrum Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10003805 Autism LLT
    Population Age: Adults Gender: Male
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-000254-28 Sponsor Protocol Number: RC31/19/0500 Start Date*: 2022-05-19
    Sponsor Name:University Hospital of Toulouse
    Full Title: Interest of oxytocin as an adjuvant treatment of psycho-educational measures in challenging behaviors in children with autism spectrum disorders and moderate to severe intellectual disability: feas...
    Medical condition: autism
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10003805 Autism LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-001266-17 Sponsor Protocol Number: DMD114349 Start Date*: 2011-08-08
    Sponsor Name:GlaxoSmithKline Research and Development LTD
    Full Title: An open-label extension study of the long-term safety, tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy
    Medical condition: Duchenne Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    16.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: BE (Prematurely Ended) FR (Ongoing) DE (Completed) GB (Prematurely Ended) NL (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended) Outside EU/EEA BG (Prematurely Ended) HU (Prematurely Ended) DK (Prematurely Ended) CZ (Prematurely Ended)
    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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