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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rufinamide | |||
| Anti-Epileptic Drugs | Includes those used off label as part of local clinical practice |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Long term use of rufinamide, and other anti-epileptic drugs | Evaluation, within the constraints of this population, of the impact on maturation anddevelopment that anti-epileptic drugs, including rufinamide, has on the LGS population; seizure control in LGS patients, including those taking rufinamide and other anti-epileptic drugs; assessment of healthcare resource utilisation. | At least three years |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graz | Austria | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28927712 | Derived | 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. |
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| 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 |
| Mantua | Italy |
| Milan | Italy |
| Padova | 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 |
| ID | Term |
|---|---|
| D065768 | Lennox Gastaut Syndrome |
| ID | Term |
|---|---|
| D000073376 | Epileptic Syndromes |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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