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Clinical trials for 2021-003015-26

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   44335   clinical trials with a EudraCT protocol, of which   7366   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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    1 result(s) found for: 2021-003015-26. Displaying page 1 of 1.
    EudraCT Number: 2021-003015-26 Sponsor Protocol Number: AMZ002-002 Start Date*: 2022-04-12
    Sponsor Name:Amzell B.V.
    Full Title: A Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to Vigabatrin, in the Treatment of Infantile Spasms
    Medical condition: Monotherapy for the treatment of infantile spasms (IS) in infants and children 2 months to 24 months of age
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10021750 Infantile spasms PT
    21.1 10029205 - Nervous system disorders 10021751 Infantile spasms, with intractable epilepsy LLT
    20.0 10029205 - Nervous system disorders 10021752 Infantile spasms, without mention of intractable epilepsy LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) FR (Ongoing) PL (Prematurely Ended) IT (Ongoing)
    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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