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
- 199
- 主要终点
- Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency
研究概览
简要总结
The primary efficacy parameter will be the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •age over 18 years old, patients with epilepsia with partial seizures
- •Enrollment to study is fully on physician decision in compliance with current SPC.
排除标准
- •Patient who did not meet indication according to SPC Lyrica
结局指标
主要结局
Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency
时间窗: Baseline through Week 16
Responders: number of subjects with a 50 percent (%) or greater reduction in partial seizure frequency from Baseline to Final visit. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase \* 28 divided by total number of days in the maintenance treatment phase. Missing category includes subjects with missing attack date, insufficient length of treatment period or no seizures in both baseline and treatment periods. Subjects with zero seizures in the baseline period and some seizures in the treatment period were treated as non-responders.
次要结局
- Antiepileptic Drugs Used in the Past(Baseline)
- Change in 28 Day Partial Seizure Frequency(Baseline through Week 16 (Final Visit ))
- Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study(Week 8 up to Week 16 (Last 4 weeks of the treatment period))
- Concomitant Drug Treatments(Baseline through Week 16 (Final Visit))
- Average Dosage of Pregabalin Taken at Baseline and Final Visit(Baseline, Week 16 (Final Visit ))
- Visual Analog Scale of Anxiety (VAS-A)(Baseline, Week 4, Week 16 (Final Visit), Last Observation Carried Forward)
- Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A)(Baseline, Week 16 (Final Visit), Last Observation Carried Forward)
- Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)(Baseline)
- Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C)(Week 16 (Final Visit))
- Medical Outcomes Sleep Scale (MOS-S)(Baseline, Week 16 (Final Visit ))
- Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale(Baseline, Week 16 (Final Visit))