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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   44364   clinical trials with a EudraCT protocol, of which   7388   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 ).  
     
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    Clinical Trial Results:
    Ensaio clínico prospectivo, randomizado, de observador cego, com grupos paralelos e multicêntrico, para avaliar a eficácia e a segurança de duas diluições diferentes de NT 201 em pacientes com espasticidade do membro superior Prospective, randomized, observer-blind, parallel-group, multi-center trial to assess efficacy and safety of two different dilutions of NT 201 in patients with upper limb spasticity

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines
    Summary
    EudraCT number
    		 2006-003036-30
    Trial protocol
    		 PT   DE   GB   AT   FR   IT  
    Global completion date
    08 May 2008

    Paediatric regulatory details
    Is the trial part of an agreed EMA paediatric investigation plan?
    No
    Is the trial in scope of article 45 of Regulation (EC) No 1901/2006?
    No
    Is the trial in scope of article 46 of Regulation (EC) No 1901/2006?
    No

    Results information
    Results version number
    		 v2(current)
    This version publication date
    25 Jan 2017
    First version publication date
    28 Dec 2016
    Other versions
    		 v1
    Version creation reason
    • Changes to summary attachments
    Exchange results summary attachment to correct upload error
    Summary report(s)
    		 CTgov_receipt_MRZ 60201-0607-1
    Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03 for further information.
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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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