European Registry of Anti-Epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS)
European Registry of Anti-epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS).
1 other identifier
observational
109
8 countries
49
Brief Summary
This is a registry study, where sites will enter patients with LGS who require a modification in anti-epileptic therapy (either the addition of another anti-epileptic drug, or the change of one drug to another). This will include patients who are started on rufinamide. Patients will be reviewed according to local practice, but it is envisaged that review will occur at approximately one month, three months and six months, and then every six months. Upon entry to the registry baseline details concerning disease severity, diagnosis, prior therapy, and developmental assessment will be recorded. On each subsequent visit the patient (usually through their caregiver) will be asked about current medication, general seizure profile, any seizures deemed to be of medical significance, tolerability, AEs (including suicidal-related events), and healthcare resource utilisation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2008
Longer than P75 for all trials
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedMay 4, 2016
May 1, 2016
7.3 years
November 18, 2013
May 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety during the use of rufinamide and other anti-epileptic drugs
Evaluation of the incidence of seizures of medical significance (including status epilepticus, new / worsening of seizure types and withdrawal seizures) during exposure to anti-epileptic drugs, including rufinamide, in patients with LGS; incidence of hypersensitivity reactions during the exposure to anti-epileptic drugs, including rufinamide; common AEs identified with anti-epileptic drugs, as they may be related to this specific population; including sedation, neurological AEs, suicidal-related events, events associated with blood dyscrasias, and the potential increased risk of infections.
At least three years
Secondary Outcomes (1)
Long term use of rufinamide, and other anti-epileptic drugs
At least three years
Study Arms (2)
Rufinamide
Anti-Epileptic Drugs
Includes those used off label as part of local clinical practice
Eligibility Criteria
Participation in this study will be offered to any patient of four years or older, who has a known diagnosis of LGS, who requires a change in anti-epileptic therapy. This will include patients who are started on rufinamide, as an adjuvant therapy.
You may qualify if:
- Patients will be four years and older
- 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
You may not qualify if:
- Female patients who are pregnant, lactating, or whom are planning to become pregnant
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Limitedlead
Study Sites (49)
Unknown Facility
Graz, Austria
Unknown Facility
Innsbruck, Austria
Unknown Facility
Linz, Austria
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Mödling, Austria
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Steyr, Austria
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Vienna, Austria
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Wein, Austria
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Copenhagen, Denmark
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Dianalund, Denmark
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Besançon, France
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Lyon, France
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Marseille, France
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Paris, France
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Reims, France
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Strasbourg, France
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Tain-l'Hermitage, France
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Berlin, Germany
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Bernau, Germany
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Bielefeld, Germany
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Bonn, Germany
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Erlangen, Germany
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Freiburg im Breisgau, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Jena, Germany
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Kehl, Germany
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Kiel, Germany
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Münster, Germany
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Stuttgart, Germany
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Tübingen, Germany
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Vogtareuth, Germany
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Mantova, Italy
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Milan, Italy
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Padua, Italy
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Roma, Italy
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Trieste, Italy
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Verona, Italy
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Barcelona, Spain
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Córdoba, Spain
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Esplugues de Llobregat, Spain
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Madrid, Spain
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Málaga, Spain
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Pamplona, Spain
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Lund, Sweden
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Birmingham, United Kingdom
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Cardiff, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Manchester, United Kingdom
Unknown Facility
West Yorkshire, United Kingdom
Related Publications (1)
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.
PMID: 28927712DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2013
First Posted
November 25, 2013
Study Start
June 1, 2008
Primary Completion
October 1, 2015
Study Completion
November 1, 2015
Last Updated
May 4, 2016
Record last verified: 2016-05