Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency
研究概览
简要总结
Clinical study with Lyrica (pregabalin) in patients suffering from epilepsy. This drug is used as adjunctive therapy with one or more antiepileptics. Lyrica has potential to reduce seizure frequency.
详细描述
- Included all adult patients with partial seizures and without contraindications according to Summary of Product Characteristics (SmPC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with partial seizures.
排除标准
- •Contraindications according to Summary of Product Characteristics (SmPC).
研究组 & 干预措施
Lyrica
Adult patients with partial seizures (type of epilepsy). Inclusion criteria according to Summary of Product Characteristics
干预措施: Lyrica (pregabalin) (Drug)
结局指标
主要结局
Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency
时间窗: Baseline through week 16 or early termination (ET)
Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 - Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency \* 100, divided by the partial seizure frequency at the baseline visit.
次要结局
- Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)(Baseline)
- Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit(Week 16 or ET)
- Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit(Baseline and week 16 or ET)
- Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study(Week 4 through week 16 or ET)
- Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit(Baseline, week 4 and week 16 or ET)
- Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET(Baseline and week 16 or ET)