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Clinical trials for Developmental Stage

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    20 result(s) found for: Developmental Stage. Displaying page 1 of 1.
    EudraCT Number: 2014-001411-39 Sponsor Protocol Number: ABT-002 Start Date*: 2018-09-04
    Sponsor Name:Abeona Therapeutics Inc
    Full Title: Phase I/II gene transfer clinical trial of rAAV9.CMV.hNAGLU for Mucopolysaccharidosis (MPS) IIIB
    Medical condition: MPS IIIB is a devastating lysosomal storage disease, caused by a N-α-acetylglucosaminidase (NAGLU) gene defect. Infants with MPS IIIB appear normal at birth, but the disease is relentlessly progre...
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Prematurely Ended) FR (Prematurely Ended) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-004860-78 Sponsor Protocol Number: P1209NY Start Date*: 2014-05-09
    Sponsor Name:G. Pohl-Boskamp GmbH & Co. KG
    Full Title: A randomised, active-controlled, observer-blind, non-inferiority study to investigate the efficacy, safety and tolerability of a local treatment with dimeticone-based pediculicides in head lice inf...
    Medical condition: Pediculosis capitis
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004862 10019199 Head pediculosis LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-001559-38 Sponsor Protocol Number: GEICAM/2018-06 Start Date*: 2022-01-20
    Sponsor Name:GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)
    Full Title: A Randomized Phase II Study to Evaluate the Incidence of Discontinuations due to Diarrhoea at 3 Cycles in patients with Early-stage HER2-positive (HER2+), Hormone Receptor-positive (HR+) Breast Can...
    Medical condition: HER2+, HR+ Early stage Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER2 positive breast cancer PT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10083234 Hormone receptor positive breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-001783-21 Sponsor Protocol Number: 3288 Start Date*: 2012-07-11
    Sponsor Name:Childrens's Research Institute
    Full Title: Optimizing Pain Treatment in Pre-Term Neonates
    Medical condition: Critically Ill Premature Neonates between 23 and 32 weeks of gestation who are receiving morphine as part of their routine medical management of pain or other medically indicated condition for whic...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10056350 Pain management PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-002425-21 Sponsor Protocol Number: 11054 Start Date*: 2012-02-10
    Sponsor Name:University of Nottingham
    Full Title: Efficacy of Dehydroepiandrosterone to overcome the effect of ovarian aging
    Medical condition: Women having low ovarian reserve undergoing IVF/ICSI treatment
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-001903-60 Sponsor Protocol Number: EFC14643 Start Date*: 2018-07-04
    Sponsor Name:Sanofi-aventis recherche & développement
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Heterozygous Famil...
    Medical condition: Hypercholesterolaemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10020603 Hypercholesterolaemia PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) FR (Completed) IT (Completed) DE (Completed) AT (Completed) Outside EU/EEA NL (Completed) HU (Completed) SI (Completed) ES (Completed) PL (Completed) FI (Completed) BG (Completed) CZ (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2019-002548-26 Sponsor Protocol Number: 0139 Start Date*: 2020-12-16
    Sponsor Name:Royal College of Surgeons in Irlenad
    Full Title: Can Pentoxifylline improve long-term outcomes in preterm infants with late-onset sepsis or necrotizing enterocolitis? A pragmatic, randomised, placebo controlled trial
    Medical condition: Late onset sepsis & necrotising enterocolitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053598 Late onset neonatal sepsis LLT
    20.1 100000004856 10028884 Necrotising enterocolitis LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-002379-40 Sponsor Protocol Number: CAFQ056B2278 Start Date*: 2012-01-09
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome
    Medical condition: Fragile X syndrome
    Disease: Version SOC Term Classification Code Term Level
    16.1 10010331 - Congenital, familial and genetic disorders 10017324 Fragile X syndrome PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) DE (Prematurely Ended) Outside EU/EEA GB (Prematurely Ended) ES (Temporarily Halted) DK (Prematurely Ended) IT (Completed) FR (Completed) NL (Prematurely Ended) BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-023777-19 Sponsor Protocol Number: SToP-BPD Start Date*: Information not available in EudraCT
    Sponsor Name:Academic Medical Center
    Full Title: Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants: the SToP-BPD study
    Medical condition: bronchopulmonary dysplasia
    Disease: Version SOC Term Classification Code Term Level
    12.1 10006475 Bronchopulmonary dysplasia LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-005336-23 Sponsor Protocol Number: Baby-OSCAR Start Date*: 2014-12-16
    Sponsor Name:University of Oxford
    Full Title: Outcome After Selective Early Treatment for Closure of Patent Ductus Arteriosus in Pre-term Babies
    Medical condition: Patent ductus arteriosus of the newborn
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2011-004184-79 Sponsor Protocol Number: NIAD-01 Start Date*: 2013-05-01
    Sponsor Name:Dermal Laboratories Limited
    Full Title: A placebo controlled evaluation of a developmental gel for the treatment of atopic eczema
    Medical condition: The medical condition to be investigated in this study is atopic eczema, also known as atopic dermatitis.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10003641 Atopic eczema LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2022-002653-26 Sponsor Protocol Number: PULMESCELL-2 Start Date*: 2023-07-21
    Sponsor Name:Fundación para la Investigación Biomédica Hospital Ramón y Cajal
    Full Title: PHASE II CLINICAL TRIAL TO ESTABLISH THE SAFETY OF THE USE OF EXPANDED ALLOGENEIC FETAL UMBILICAL CORD STEM MESENCHYMAL CELLS IN PRETERM PATIENTS WITH BRONCHOPULMONARY DYSPLASIA
    Medical condition: Live newborns weighing ≤ 1250 grams and gestational age ≤ 28 weeks, who are on mechanical ventilation with a FiO2 ≥ 0.3 between days 5 and 14 of life, with no immediate extubation foreseeable
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2023-001104-33 Sponsor Protocol Number: AT0071002 Start Date*: 2023-12-22
    Sponsor Name:Applied Therapeutics Inc.
    Full Title: A Sequential, Two-Part Study to Evaluate the Clinical Benefit, Safety, Pharmacokinetics, and Pharmacodynamics of AT-007 in Pediatric Patients with Classic Galactosemia (CG)
    Medical condition: Galactosemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10017610 Galactosemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2011-001785-17 Sponsor Protocol Number: GENA-13 Start Date*: 2011-09-27
    Sponsor Name:Octapharma AG
    Full Title: Clinical Study in Previously Treated Children with Severe Haemophilia A to Investigate the Long-Term Immunogenicity, Tolerability and Efficacy of Human-cl rhFVIII
    Medical condition: Severe Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (Completed) FR (Completed) CZ (Completed) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2017-001531-40 Sponsor Protocol Number: WIL-30 Start Date*: 2020-08-13
    Sponsor Name:Octapharma AG
    Full Title: Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Pediatric Patients with Severe Hemophilia A
    Medical condition: Severe hemophilia A (<1% FVIII:C)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-004058-11 Sponsor Protocol Number: RM-493-023 Start Date*: Information not available in EudraCT
    Sponsor Name:Rhythm Pharmaceuticals, Inc.
    Full Title: A Phase 3 trial of Setmelanotide (RM-493), a Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström syndrome (AS) Patients with Moderate to Severe Obesity
    Medical condition: Obesity and hyperphagia in patients with Bardet-Biedl Syndrome or Alström syndrome
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed) ES (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2007-006997-27 Sponsor Protocol Number: CRAD001M2301 Start Date*: 2011-06-01
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, double-blind, placebo-controlled study of RAD001 in the treatment of patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC)
    Medical condition: This study will evaluate the antitumor activity of RAD001 versus placebo in patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC).
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) IT (Completed) GB (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-000618-20 Sponsor Protocol Number: 40084-22084 Start Date*: 2012-11-05
    Sponsor Name:European Organization for the Research and Treatment of Cancer (EORTC)
    Full Title: A PHASE II-R and A PHASE III TRIAL EVALUATING BOTH *ERLOTINIB (PH II-R) AND CHEMORADIATION (PH III) AS ADJUVANT TREATMENT FOR PATIENTS WITH RESECTED HEAD OF PANCREAS ADENOCARCINOMA
    Medical condition: Patients with resected head of pancreas adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052747 Adenocarcinoma pancreas PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003441-38 Sponsor Protocol Number: 1042-TSC-3001 Start Date*: Information not available in EudraCT
    Sponsor Name:Marinus Pharmaceuticals Inc.
    Full Title: A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults with Tuberous Sclerosis Complex (TSC)-related Epilepsy (TrustTSC)
    Medical condition: Tuberous Sclerosis Complex (TSC)-related epilepsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10032062 Other forms of epilepsy, with intractable epilepsy LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) DE (Ongoing) ES (Ongoing) IT (Ongoing) BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-000974-22 Sponsor Protocol Number: MRX-701 Start Date*: 2021-01-29
    Sponsor Name:Mirum Pharmaceuticals Inc.
    Full Title: Randomized, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects with Biliary Atresia after Hepatoportoenterostomy
    Medical condition: Biliary atresia (BA) is a rare, inflammatory condition of the biliary tree that presents in the first weeks of life and leads to bile duct obstruction and consequent liver injury, fibrosis and cirr...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10004653 Biliary atresia LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) FR (Ongoing) PL (Completed) GB (GB - no longer in EU/EEA) IT (Ongoing)
    Trial results: (No results available)
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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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