European Registry of Anti-Epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||European Registry of Anti-epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS).|
- Safety during the use of rufinamide and other anti-epileptic drugs [ Time Frame: At least three years ] [ Designated as safety issue: Yes ]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.
- Long term use of rufinamide, and other anti-epileptic drugs [ Time Frame: At least three years ] [ Designated as safety issue: No ]Evaluation, within the constraints of this population, of the impact on maturation and development 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.
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Includes those used off label as part of local clinical practice