NCT01863602已完成不适用
Special Drug Use Investigation for LAMICTAL (Long Term)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 850
- 主要终点
- The incidence of adverse drug reactions
研究概览
简要总结
The objectives of this post-marketing surveillance (PMS) are to grasp the actual use of lamotrigine tablets to collect safety information in the long-term use according to seizure type and concomitant antiepileptic drug (AED), and to confirm its efficacy.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome
- •Subjects who are treated with lamotrigine tablets
排除标准
- 未提供
研究组 & 干预措施
Subjects prescribed lamotrigine tablets
Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome to whom lamotrigine tablets are administered.
干预措施: Lamotrigine tablets (Drug)
结局指标
主要结局
The incidence of adverse drug reactions
时间窗: 1 year
Occurrence of skin disorder after the start of treatment
时间窗: 1 year
Presence or absence of skin disorder and its details after the start of treatment will be investigated as a priority investigation item
次要结局
- Overall improvement of subjects' symptoms(1 year)
研究者
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