European Registry of Anti-Epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS)
NCT ID: NCT01991041
Last Updated: 2016-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
109 participants
OBSERVATIONAL
2008-06-30
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rufinamide
No interventions assigned to this group
Anti-Epileptic Drugs
Includes those used off label as part of local clinical practice
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients will have an established diagnosis of Lennox-Gastaut syndrome, and:
* Documented history or current presence of multiple seizure types associated with LGS (including tonic or atonic seizures (drop attacks) and atypical absences)
* Documented history or current presence of typical EEG abnormalities (e.g., bursts of slow spike and wave activity)
* Presence of intellectual / learning disability (a variable degree is permitted)
* Patients entered on the registry will be those requiring a modification in their current anti-epileptic medication. This includes but is not limited to patients who are commenced on rufinamide as adjuvant therapy
Exclusion Criteria
* Female patients, of child bearing potential, who are not willing to use appropriate contraception (This is at the discretion of the investigator)
* Those starting rufinamide and for whom the investigator considers it necessary to administer in contradiction to the indications, and warnings within the current Summary of Product Characteristics (SPC).
4 Years
ALL
No
Sponsors
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Eisai Limited
INDUSTRY
Responsible Party
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Locations
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Graz, , Austria
Innsbruck, , Austria
Linz, , Austria
Mödling, , Austria
Steyr, , Austria
Vienna, , Austria
Wein, , Austria
Copenhagen, , Denmark
Dianalund, , Denmark
Besançon, , France
Lyon, , France
Marseille, , France
Paris, , France
Reims, , France
Strasbourg, , France
Tain-l'Hermitage, , France
Berlin, , Germany
Bernau, , Germany
Bielefeld, , Germany
Bonn, , Germany
Erlangen, , Germany
Freiburg im Breisgau, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Jena, , Germany
Kehl, , Germany
Kiel, , Germany
Münster, , Germany
Stuttgart, , Germany
Tübingen, , Germany
Vogtareuth, , Germany
Mantova, , Italy
Milan, , Italy
Padua, , Italy
Roma, , Italy
Trieste, , Italy
Verona, , Italy
Barcelona, , Spain
Córdoba, , Spain
Esplugues de Llobregat, , Spain
Madrid, , Spain
Málaga, , Spain
Pamplona, , Spain
Lund, , Sweden
Birmingham, , United Kingdom
Cardiff, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
West Yorkshire, , United Kingdom
Countries
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References
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Nikanorova M, Brandt C, Auvin S, McMurray R. Real-world data on rufinamide treatment in patients with Lennox-Gastaut syndrome: Results from a European noninterventional registry study. Epilepsy Behav. 2017 Nov;76:63-70. doi: 10.1016/j.yebeh.2017.08.026. Epub 2017 Sep 15.
Other Identifiers
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E2080-E044-401
Identifier Type: -
Identifier Source: org_study_id
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