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This surveillance's objectives are
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2080 | Children ages >= 4 years: Patients weighing 15.0-30.0 kg: oral daily dose of 200 mg in two divided doses after meals for the first 2 days. The dose will be increased by up to 200 mg/day every two days. The maintenance dose should be 1000 mg/day in two divided doses after meals. The dose can be increased or decreased within a range not exceeding 1000 mg/day, and should be increased by up to 200 mg/day at intervals not less than 2 days. Patients weighing >= 30.1 kg: Adults: oral daily dose of 400 mg in two divided doses after meals for the first 2 days, then increased by up to 400 mg/day every two days. The maintenance dose should be 1800 mg/day for patients weighing 30.1-50.0 kg, 2400 mg/day for patients weighing 50.1-70.0 kg, and 3200 mg/day for patients weighing 70.1 kg or over in two divided doses after meals. Dose can be increased or decreased within a range not exceeding the above maintenance dose, and should be increased by up to 400 mg/day at intervals not less than 2 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rufinamide | Drug | Administration of Inovelon 100mg or 200mg Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigations on adverse events and adverse drug reactions | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of attacks | 12 weeks and every 6 months up to 2years | |
| Overall assessments of the improvement in the seriousness of seizures | 12 weeks and every 6 months up to 2years |
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All patients with Lennox-Gastaut syndrome and administrated Inovelon
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Patients with Lennox-Gastaut Syndrome
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Japan | |||||
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| ID | Term |
|---|---|
| D065768 | Lennox Gastaut Syndrome |
| C535500 | Epileptic encephalopathy, Lennox-Gastaut type |
| ID | Term |
|---|---|
| D000073376 | Epileptic Syndromes |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C079703 | rufinamide |
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| Tokyo |
| Japan |
| D009422 |
| Nervous System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |