Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 707
- 主要终点
- Investigations on adverse events and adverse drug reactions
研究概览
简要总结
This surveillance's objectives are
- Unknown adverse reactions
- Incidences of adverse drug reaction
- Efficacy during long-term administration
- Factors considered to have effect to safety and effectiveness
- Incidences of status epileptics, skin disorders and hyper sensitivity reaction, and central nervous system-related adverse events(ataxia , somnolence and/or dizzy, etc.)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Rufinamide (Drug)
结局指标
主要结局
Investigations on adverse events and adverse drug reactions
时间窗: Up to 2 years
次要结局
- Overall assessments of the improvement in the seriousness of seizures(12 weeks and every 6 months up to 2years)
- Frequency of attacks(12 weeks and every 6 months up to 2years)