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Clinical trials for Rufinamide

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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    6 result(s) found for: Rufinamide. Displaying page 1 of 1.
    EudraCT Number: 2010-023505-36 Sponsor Protocol Number: E2080-G000-303 Start Date*: Information not available in EudraCT
    Sponsor Name:Eisai Ltd
    Full Title: A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to ...
    Medical condition: Lennox Gastaut Syndrome
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) IT (Completed) GR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004944-12 Sponsor Protocol Number: E2080-A001-301 Start Date*: 2017-03-14
    Sponsor Name:Eisai Inc.
    Full Title: A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients with Refractory Partial Seizures
    Medical condition: Refractory partial seizures
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004950-14 Sponsor Protocol Number: E2080-A001-302 Start Date*: 2017-04-21
    Sponsor Name:Eisai Inc.
    Full Title: An Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients with Refractory Partial Seizures
    Medical condition: Refractory partial seizures
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004953-34 Sponsor Protocol Number: E2080-J081-305 Start Date*: 2017-02-23
    Sponsor Name:Eisai Co, Ltd.
    Full Title: A Long Term Extension Study of E2080 in Patients with Lennox-Gastaut Syndrome
    Medical condition: Lennox-Gastaut Syndrome
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004952-30 Sponsor Protocol Number: E2080-J081-304 Start Date*: 2017-02-13
    Sponsor Name:Eisai Co, Ltd.
    Full Title: A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients
    Medical condition: Lennox-Gastaut Syndrome (LSG)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-002195-40 Sponsor Protocol Number: 13/0656 Start Date*: 2014-09-02
    Sponsor Name:University College London
    Full Title: A randomised controlled trial of the ketogenic diet in the treatment of epilepsy in children under the age of two years
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
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    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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