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Clinical trials for NIH Toolbox

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   44363   clinical trials with a EudraCT protocol, of which   7387   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.
    How to search [pdf]
    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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    3 result(s) found for: NIH Toolbox. Displaying page 1 of 1.
    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: 2017-001982-26 Sponsor Protocol Number: OZM-063 Start Date*: 2018-04-26
    Sponsor Name:The Hospital for Sick Children
    Full Title: A phase II, open-labeled, multi-center, randomized controlled trial of Vinblastine +/- Bevacizumab for the treatment of chemotherapy-naïve children with unresectable or progressive low grade glioma...
    Medical condition: Unresectable or progressive low grade glioma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018338 Glioma PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-004539-36 Sponsor Protocol Number: 16NC06 Start Date*: 2020-05-19
    Sponsor Name:Great Ormond Street Hospital for Children NHS Foundation Trust
    Full Title: Study of Montelukast In Children with Sickle Cell Disease (SMILES)
    Medical condition: Sleep-disordered breathing
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10078294 Obstructive sleep apnoea hypopnoea syndrome LLT
    21.0 100000004855 10040977 Sleep apnoea LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
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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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