Efficacy and Safety of Generic Substitution of Original Levetiracetam in Patients With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change from baseline seizure frequency
研究概览
简要总结
The retrospective pre-post observational study was conducted to evaluate the real-world evidence of efficacy and tolerability of generic levetiracetam (oral tablet) which was switched from original levetiracetam (oral tablet) in patients with epilepsy at the national hospital for neurology and neurosurgery in Thailand. Epilepsy patients who received generic substitution to original levetiracetam at the same dose and had stable conditions of seizure were only included. In the period of 6 months, the investigators assessed the change of seizure frequency, the incidence of hospitalization due to breakthrough seizure, the incidence of adverse events and the incidence of composite outcomes related to dosage adjustment of antiepileptic drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of epilepsy for at least 6 months prior to generic levetiracetam substitution;
- •Same dosage form and strength of generic substitution to original levetiracetam;
- •Stable dose of original levetiracetam and stable seizure frequency prior to generic levetiracetam substitution;
- •Stable dose of generic levetiracetam after generic levetiracetam substitution
排除标准
- •Absence seizure with levetiracetam monotherapy;
- •Original levetiracetam in dosage form of oral solution or intravenous solution prior to generic levetiracetam substitution;
- •Poor compliance;
- •Death or loss of follow up;
- •Unavailable data for evaluation of outcomes
研究组 & 干预措施
Generic levetiracetam
干预措施: Generic levetiracetam (Drug)
结局指标
主要结局
Change from baseline seizure frequency
时间窗: At baseline, 3 and 6 months after generic levetiracetam substitution
Change from baseline seizure frequency per month at 3 and 6 months
次要结局
- Composite outcomes(During 6 months of generic levetiracetam substitution)
- Hospitalization(During 6 months of generic levetiracetam substitution)
- Adverse events(During 6 months of generic levetiracetam substitution)