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Clinical trials for Exposure hierarchy

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   44339   clinical trials with a EudraCT protocol, of which   7369   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: Exposure hierarchy. Displaying page 1 of 1.
    EudraCT Number: 2008-002062-62 Sponsor Protocol Number: ALS-TAL-201 Start Date*: 2008-10-14
    Sponsor Name:Teva Pharmaceutical Industries, Ltd
    Full Title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral S...
    Medical condition: Amyotrophic lateral sclerosis (ALS).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052653 Amyotrophic lateral sclerosis gene carrier PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) FR (Completed) ES (Completed) IT (Completed) BE (Completed) HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-002754-36 Sponsor Protocol Number: 3119002 Start Date*: 2018-05-08
    Sponsor Name:Orion Corporation
    Full Title: Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS
    Medical condition: Amyotrophic lateral sclerosis (ALS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10002026 Amyotrophic lateral sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) BE (Completed) FI (Completed) AT (Completed) ES (Completed) NL (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-000985-21 Sponsor Protocol Number: Bay14-2222/12800 Start Date*: 2009-12-07
    Sponsor Name:Bayer HealthCare Pharmaceuticals Inc
    Full Title: Randomized, controlled, parallel, prospective trial to evaluate the effect of secondary prophylaxis with rFVIII therapy in severe hemophilia A adult and/or adolescent subjects, as applicable, compa...
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10060612 Hemophilia A LLT
    Population Age: Adults Gender: Male
    Trial protocol: BG (Completed)
    Trial results: View results
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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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