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Clinical trials for 2009-014544-11

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.

    The EU Clinical Trials Register currently displays   37556   clinical trials with a EudraCT protocol, of which   6160   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).
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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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    1 result(s) found for: 2009-014544-11. Displaying page 1 of 1.
    EudraCT Number: 2009-014544-11 Sponsor Protocol Number: C10953/3069/ES/MN Start Date*: 2010-05-21
    Sponsor Name:Cephalon Inc
    Full Title: Estudio abierto de 12 meses para la evaluación de la seguridad, la tolerabilidad y la eficacia de armodafinil (150 mg/día y 250 mg/día) como tratamiento para pacientes con somnolencia excesiva asoc...
    Medical condition: Pacientes con somnolencia excesiva asociada a un trauma craneo-cerebral no penetrante leve o moderado. Excessive sleepiness accociated with mild or moderate closed traumatic brain injury
    Disease: Version SOC Term Classification Code Term Level
    12.0 10060690 Traumatic brain injury LLT
    12.0 10015595 Excessive daytime sleepiness LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Prematurely Ended)
    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.
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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