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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   44338   clinical trials with a EudraCT protocol, of which   7368   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 3 of 36.
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    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: 2018-004409-17 Sponsor Protocol Number: M16-049 Start Date*: 2019-06-24
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: An Open-label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects with Severe Atopic Dermatitis
    Medical condition: Severe Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10012438 Dermatitis atopic PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NO (Completed) NL (Ongoing)
    Trial results: View results
    EudraCT Number: 2018-002924-18 Sponsor Protocol Number: 1517-CL-1001 Start Date*: 2019-07-11
    Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
    Full Title: A Phase 1 Crossover Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet and Pediatric Azo Dye free Mini-tablet (Solid and Suspension)...
    Medical condition: Healthy Adult Volunteers (intended indication is anemia associated with chronic kidney disease (CKD))
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10002272 Anemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-003120-17 Sponsor Protocol Number: PDY16963 Start Date*: Information not available in EudraCT
    Sponsor Name:Genzyme Corporation
    Full Title: A 3-part study to evaluate the efficacy and safety of venglustat in combination with Cerezyme in adult and pediatric patients with Gaucher disease Type 3 (GD3) with open-label long-term treatment
    Medical condition: Gaucher disease type 3
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10075699 Gaucher's disease type III PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) DE (Prematurely Ended) HU (Prematurely Ended) FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-000953-38 Sponsor Protocol Number: MK-1986-014 Start Date*: 2018-02-07
    Sponsor Name:Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1, Single-and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old
    Medical condition: Treatment or prophylaxis against Gram-positive infections
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BG (Completed) GB (GB - no longer in EU/EEA) NO (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-004082-27 Sponsor Protocol Number: 117366 Start Date*: 2017-11-14
    Sponsor Name:LLC Novartis Pharma
    Full Title: An extension study of eltrombopag in pediatric patients with chronic immune (idiopathic) thrombocytopenia purpura (ITP)
    Medical condition: Chronic immune (idiopathic) thrombocytopenia purpura
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10005329 Blood and lymphatic system disorders SOC
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-001294-84 Sponsor Protocol Number: OPBGC&RS2011-004_CA2012 Start Date*: 2012-09-03
    Sponsor Name:EDISON PHARMACEUTICALS INC.
    Full Title: Prospective open label trial to evaluate the maintenance of the efficacy and the long term safety of EPI-743 in children with Leigh Disease
    Medical condition: Leigh Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10027433 Metabolism and nutrition disorders SOC
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-000174-11 Sponsor Protocol Number: CN138603 Start Date*: 2017-04-07
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc
    Full Title: Safety and Efficacy of Aripiprazole in the Long-Term Maintenance Treatment of Pediatric Subjects with Irritability Associated with Autistic Disorder
    Medical condition: Irritability in Autism Disorder
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-006352-36 Sponsor Protocol Number: VPN-10-18 Start Date*: 2013-04-11
    Sponsor Name:Lithuanian University of Health Sciences, Endocrinology Department
    Full Title: Obesity in children and adolescents: complications, associated risks and early intervention (lifestyle changes and insulin sensitivity improving medicine (metformin) effectiveness and safety evalua...
    Medical condition: The aim of our study is to establish the effectivenes and safety of metformin use in pediatric obese population; to assess the prevalence of insulin resistance, metabolic syndrome, polycystic ovary...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10029883 Obesity PT
    14.1 10027433 - Metabolism and nutrition disorders 10033307 Overweight PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-011115-20 Sponsor Protocol Number: NordLOTS protocol step 3 1.1 Start Date*: 2009-08-14
    Sponsor Name:The Centre for Child and Adolescent Mental Health, Eastern and Southern Norway (R.BUP)
    Full Title: Nordic Longterm OCD treatment Study: A Nordic Multicenter treatment study evaluating a stepped care model based on the "Expert Clinical Guidelines". The study is performed with no sponsor from phar...
    Medical condition: Obsessive Compulsive Disorder
    Disease: Version SOC Term Classification Code Term Level
    9.1 10049596 Obsession LLT
    9.1 10010219 Compulsions LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing) NO (Ongoing) DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-002253-30 Sponsor Protocol Number: INCB39110-120 Start Date*: 2019-07-01
    Sponsor Name:Incyte Corporation
    Full Title: An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in...
    Medical condition: Male or female, 28 days to less than 18 years of age, who have received an allogeneic hematopoietic stem cell transplant (allo-HSCT) and have developed Grade II to IV acute GVHD
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021428 - Immune system disorders 10066260 Acute graft versus host disease PT
    20.1 10021428 - Immune system disorders 10066262 Acute graft versus host disease in skin PT
    20.1 10021428 - Immune system disorders 10066264 Acute graft versus host disease in intestine PT
    20.1 10021428 - Immune system disorders 10066263 Acute graft versus host disease in liver PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) FR (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-022647-38 Sponsor Protocol Number: P06107 Start Date*: 2011-11-16
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering Corporation
    Full Title: Efficacy and Safety of 3-Week Fixed-Dose Asenapine Treatment in Pediatric Acute Manic or Mixed Episodes Associated with Bipolar I Disorder (Protocol No. P06107)
    Medical condition: Acute Manic or Mixed Episodes Associated with Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    14.0 10037175 - Psychiatric disorders 10068455 Bipolar I disorder, hypomanic LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-006788-11 Sponsor Protocol Number: NBI-827104-CSWS2025 Start Date*: 2022-03-25
    Sponsor Name:Neurocrine Biosciences, Inc.
    Full Title: Long-Term, Open-Label Extension Study to Evaluate the Safety and Tolerability of NBI-827104 in Pediatric Subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep
    Medical condition: Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (EECSWS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10077380 Epileptic encephalopathy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed) ES (Completed) DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-004849-26 Sponsor Protocol Number: Parachute04 Start Date*: 2015-02-05
    Sponsor Name:UMC Utrecht
    Full Title: PARACHUTE-trial Prospective Analysis of an individualized dosing Regimen of ATG (Thymoglobulin) in Children Undergoing HCT: redUcing Toxicity and improving Efficacy – a single arm phase II study
    Medical condition: Leukemia and immunedeficiency syndromes
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10021428 Immune system disorders SOC
    20.1 100000004864 10024329 Leukemia LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-005624-98 Sponsor Protocol Number: 109MS309 Start Date*: 2015-09-09
    Sponsor Name:Biogen Idec Research Limited
    Full Title: A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms o...
    Medical condition: Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    18.0 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) EE (Prematurely Ended) AT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-004379-38 Sponsor Protocol Number: H8H-MC-LAHW Start Date*: Information not available in EudraCT
    Sponsor Name:Eli Lilly and Company
    Full Title: A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients with Migraine
    Medical condition: Migraine
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10027599 Migraine PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) GB (GB - no longer in EU/EEA) BE (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004643-12 Sponsor Protocol Number: POP6739 Start Date*: 2015-03-26
    Sponsor Name:Sanofi-aventis
    Full Title: Post-marketing study of Amaryl® (Glimepiride) in patients with type 2 diabetes to investigate pediatric and adult population pharmacokinetics [multicenter, non-comparative, 12-28 weeks, non-blind t...
    Medical condition: Patients with type 2 diabetes
    Disease: Version SOC Term Classification Code Term Level
    17.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-003008-38 Sponsor Protocol Number: 105MS306 Start Date*: 2019-06-17
    Sponsor Name:Biogen Idec Research Limited
    Full Title: An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years f...
    Medical condition: Relapsing Remitting Multiple Sclerosis (RRMS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    20.0 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) FR (Completed) PT (Completed) BG (Trial now transitioned) HU (Trial now transitioned) BE (Completed) SK (Trial now transitioned) GR (Completed) DE (Completed) ES (Ongoing) HR (Trial now transitioned) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004301-31 Sponsor Protocol Number: MLN0002-3025 Start Date*: 2021-06-25
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Dise...
    Medical condition: Moderately to severely active Crohn’s disease (CD)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10058815 Crohn's disease acute episode LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Completed) CZ (Prematurely Ended) SK (Prematurely Ended) HU (Trial now transitioned) IT (Trial now transitioned) ES (Prematurely Ended) HR (Trial now transitioned) PL (Trial now transitioned) BE (Trial now transitioned) Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2021-003265-36 Sponsor Protocol Number: AG348-C-022 Start Date*: 2022-05-10
    Sponsor Name:Agios Pharmaceuticals, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Subjects With Pyruvate Kinase Deficiency Who Are Regularly T...
    Medical condition: Pyruvate Kinase Deficiency
    Disease: Version SOC Term Classification Code Term Level
    21.1 10010331 - Congenital, familial and genetic disorders 10037682 Pyruvate kinase deficiency anaemia PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) CZ (Trial now transitioned) DK (Trial now transitioned) IT (Prematurely Ended) NL (Trial now transitioned)
    Trial results: (No results available)
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    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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