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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   44393   clinical trials with a EudraCT protocol, of which   7405   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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    715 result(s) found for: Pediatric Disorders. Displaying page 5 of 36.
    « Previous 1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2024-000605-33 Sponsor Protocol Number: VENL-CAZ-3002 Start Date*: 2026-03-17
    Sponsor Name:Viatris Pharmaceutical Japan GK
    Full Title: An open-label, long-term extension, multicenter study to evaluate the safety and efficacy of venlafaxine in Japanese pediatric outpatients with Major Depressive Disorder (MDD) or Persistent Depress...
    Medical condition: Major Depressive Disorder (MDD) or Persistent Depressive Disorder (PDD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2017-003649-10 Sponsor Protocol Number: CA40192 Start Date*: 2018-03-13
    Sponsor Name:Roche Farma S.A. (Soc unipersonal) que realiza el ensayo en España y que actúa como represntante de FHoffmann-La Roche
    Full Title: A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LES...
    Medical condition: Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    20.0 10017947 - Gastrointestinal disorders 10009900 Colitis ulcerative PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) GB (GB - no longer in EU/EEA) PL (Prematurely Ended) DE (Completed) BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-003333-11 Sponsor Protocol Number: AG348-C-023 Start Date*: 2022-04-25
    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 Not Regular...
    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: ES (Ongoing) DE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-003482-25 Sponsor Protocol Number: CICL670F2429 Start Date*: 2018-04-19
    Sponsor Name:Novartis Pharma AG
    Full Title: A single-arm interventional Phase IV, post-authorisation study evaluating the safety of pediatric patients with transfusional hemosiderosis treated with deferasirox crushed film coated tablets
    Medical condition: Transfusional Hemosiderosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10019613 Hemosiderosis LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003246-26 Sponsor Protocol Number: HPN-100-005SO Start Date*: 2015-02-10
    Sponsor Name:Hyperion Therapeutics, Inc.
    Full Title: A Phase 2, Fixed-Sequence, Open-Label, Switch-Over Study of the Safety and Tolerability of HPN 100 Compared to Sodium Phenylbutyrate in Children 6–17 Years of Age with Urea Cycle Disorders, with a ...
    Medical condition: Urea Cycle Disorders (UCDs)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-002807-10 Sponsor Protocol Number: 5592-097 Start Date*: 2015-09-02
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous (IV) and Powder for Oral Suspension Formulations of Posaconazole (POS) in Immunocompromised Pediatric Subjects with Neutropenia
    Medical condition: Prophylaxis of invasive fungal infections in immunocompromised pediatric subjects with neutropenia or expected neutropenia.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10017534 Fungal infection NOS LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) NO (Completed) SE (Completed) DK (Completed) CZ (Completed) ES (Completed) BE (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-001900-13 Sponsor Protocol Number: D4280C00014 Start Date*: 2013-06-05
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase I Study to Assess the Pharmacokinetics, Safety and Tolerability of a Single Dose of Ceftazidime-Avibactam (CAZ-AVI) in Children From 3 Months of Age to <18 Years Who Are Receiving Systemic ...
    Medical condition: hospitalized pediatric patients receiving systemic antibiotic therapy for suspected or confirmed infection.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10021804 Infection bacterial LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-003394-15 Sponsor Protocol Number: VP-VEC-162-4201 Start Date*: 2016-06-28
    Sponsor Name:Vanda Pharmaceuitcals Inc.
    Full Title: OPEN-LABEL STUDY TO INVESTIGATE THE PHARMACOKINETICS AND SAFETY OF TASIMELTEON IN TOTALLY BLIND CHILDREN AND ADOLESCENTS WITH NON-24-HOUR SLEEP- WAKE DISORDER
    Medical condition: This study will be an open-label, single dose, non-controlled trial to evaluate the pharmacokinetics and safety of tasimelteon in children who are 3 years to less than 18 years of age, totally blin...
    Disease: Version SOC Term Classification Code Term Level
    19.0 10037175 - Psychiatric disorders 10040984 Sleep disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-023505-36 Sponsor Protocol Number: E2080-G000-303 Start Date*: Information not available in EudraCT
    Sponsor Name:Eisai Ltd
    Full Title: A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to ...
    Medical condition: Lennox Gastaut Syndrome
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) IT (Completed) GR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-002528-42 Sponsor Protocol Number: 0431-083 Start Date*: 2011-12-30
    Sponsor Name:Merck Sharp & Dohme Corp. A subsidiary of Merck & Co. Inc
    Full Title: A Phase III, Multicenter, Double-Blind, Randomized, Placebo- and Metformin-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric Patients with Type 2 Diabetes Me...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LV (Completed) LT (Completed) DE (Completed) ES (Prematurely Ended) IT (Completed) BG (Completed) AT (Completed) DK (Completed) SE (Completed) HU (Completed) PL (Completed) SK (Completed) Outside EU/EEA GR (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-003976-42 Sponsor Protocol Number: OT_101_001 Start Date*: Information not available in EudraCT
    Sponsor Name:Ocumension (Hong Kong) Limited
    Full Title: A phase III, randomized, double-masked, placebo controlled, parallel-group, multicenter study of the safety and efficacy of OT-101 (Atropine 0.01%) in treating the progression of myopia in pediatri...
    Medical condition: myopia
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) SK (Trial now transitioned) IE (Trial now transitioned) HU (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-000175-86 Sponsor Protocol Number: CN138-180 Start Date*: 2017-04-07
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization,
    Full Title: A 52-Week, Open-label, Multicenter Study of the Safety and Tolerability 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: 2017-000239-15 Sponsor Protocol Number: SFY10717 Start Date*: 2017-03-20
    Sponsor Name:Sanofi
    Full Title: An open-label, uncontrolled 4-week study to assess the safety, efficacy and pharmacokinetics of Allegra® (dry syrup formulation) 15 mg or 30 mg twice daily in pediatric patients with perennial all...
    Medical condition: Rhinitis perennial
    Disease: Version SOC Term Classification Code Term Level
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10039094 Rhinitis perennial PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-003028-19 Sponsor Protocol Number: PS_KSS_001_2019 Start Date*: 2019-10-30
    Sponsor Name:IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA
    Full Title: Clinical-instrumental definition of the phenotypic spectrum, response to treatment and natural history in Pearson and Kearns-Sayre syndrome
    Medical condition: Pearson and Kearns-Sayre syndrome.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10058799 Mitochondrial encephalomyopathy PT
    20.1 10010331 - Congenital, familial and genetic disorders 10058799 Mitochondrial encephalomyopathy PT
    20.1 10010331 - Congenital, familial and genetic disorders 10051403 Mitochondrial DNA deletion PT
    20.1 10010331 - Congenital, familial and genetic disorders 10051403 Mitochondrial DNA deletion PT
    20.0 10010331 - Congenital, familial and genetic disorders 10074070 Mitochondrial encephalopathy LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-003144-76 Sponsor Protocol Number: GBT440-038 Start Date*: 2020-01-10
    Sponsor Name:Global Blood Therapeutics, Inc.
    Full Title: An Open-Label Extension Study of Voxelotor Administered Orally to Pediatric Participants with Sickle Cell Disease Who Have Participated in Voxelotor Clinical Trials
    Medical condition: Sickle Cell Disease
    Disease: Version SOC Term Classification Code Term Level
    21.0 10010331 - Congenital, familial and genetic disorders 10040644 Sickle cell disease PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2009-016374-32 Sponsor Protocol Number: MK-0462-082 Start Date*: 2010-02-15
    Sponsor Name:Merck & Co., Inc.
    Full Title: A Worldwide, Randomized, Double Blind, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adole...
    Medical condition: Acute treatment of migraine, with or without aura, in children and adolescents, ages 6 to 17 years, who do not have a satisfactory response to prior treatment with nonsteroidal anti-inflammatory dr...
    Disease: Version SOC Term Classification Code Term Level
    12.0 10066635 Acute migraine LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) FI (Completed) BE (Completed) ES (Completed) EE (Completed) LV (Completed) SE (Completed) FR (Completed) DK (Completed) GB (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-004154-25 Sponsor Protocol Number: CLCZ696B2319E1 Start Date*: Information not available in EudraCT
    Sponsor Name:Novartis Pharma AG
    Full Title: A multicenter study to evaluate long-term safety and tolerability of open label sacubitril/valsartan in pediatric patients with heart failure due to systemic left ventricle systolic dysfunction wh...
    Medical condition: Pediatric heart failure : Patients (≥ 13 months) with HF due to systemic left ventricular systolic dysfunction. [Note: All patients per protocol for the core study CLCZ696B2319 (PANORAMA-HF) ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10019279 Heart failure LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: PL (Completed) FR (Completed) BG (Completed) PT (Completed) CZ (Completed) ES (Ongoing) HU (Completed) HR (Completed) DE (Completed) AT (Completed) IT (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2011-004618-40 Sponsor Protocol Number: 20110100 Start Date*: Information not available in EudraCT
    Sponsor Name:Amgen Inc.
    Full Title: An Open-label, Single-arm Study to Assess the Safety and Tolerability of Cinacalcet HCl in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Years with Chronic Kidney Disease an...
    Medical condition: Secondary hyperparathyroidism in pediatric subjects with chronic kidney disease receiving hemodialysis or peritoneal dialysis
    Disease: Version SOC Term Classification Code Term Level
    16.0 10014698 - Endocrine disorders 10020708 Hyperparathyroidism secondary PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) NL (Temporarily Halted) PL (Completed) HU (Completed) CZ (Completed) IT (Completed) SK (Completed) BE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-001630-33 Sponsor Protocol Number: MEM-MD-69 Start Date*: 2012-11-14
    Sponsor Name:Forest Research Institute, Inc
    Full Title: An Open-Label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients with Autism, Asperger’s Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
    Medical condition: Autism or Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with Memantine
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10003484 Asperger's disorder PT
    14.1 10029205 - Nervous system disorders 10008520 Childhood autism LLT
    14.1 10037175 - Psychiatric disorders 10034739 Pervasive developmental disorder NOS LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) BE (Completed) ES (Completed) NL (Ongoing) EE (Completed) FR (Ongoing) IS (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001156-19 Sponsor Protocol Number: D9614C00007 Start Date*: 2012-03-08
    Sponsor Name:AstraZeneca LP
    Full Title: A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Esomeprazole Magnesium in Pediatric Patients 1 to 11 Years-Old Inclusive with Endoscopically-Proven Gastroeso...
    Medical condition: Pediatric patients 1 to 11 years old, inclusive, with endoscopically-proven GERD.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10017885 Gastrooesophageal reflux disease PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
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