Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial. A Phase IV Open-Label Trial Using 150,300, 600 mg/Day Of Pregabalin
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase
研究概览
简要总结
The purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED (Antiepileptic drugs).
详细描述
This study was terminated on 17 March 2009 due to delayed enrollment. The decision to terminate the trial was not based on any safety concerns, but rather on timelines and the difficulty in enrolling patients in this open label, single group study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or Female who are diagnosed of partial seizure (simple partial, complex partial, partial seizure secondarily generalized) as defined in the international league of epilepsy classification of seizure.
排除标准
- •Patients having a treatable cause of seizure, currently receiving vigabatrin, having a progressive neurological or systemic disorder.
研究组 & 干预措施
Pregabalin
干预措施: Pregabalin (Drug)
结局指标
主要结局
Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase
时间窗: Week 9 to Week 21 or End of Treatment (early termination)
28-day seizure rate (at observation period \[obs\]) = \[(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 \[Week 9\] date)\] \* 28. Percent change = \[(28-day seizure rate obs minus 28-day seizure rate at baseline \[b\]) divided by 28-day seizure rate b\] \* 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency.
次要结局
- Response Ratio (RR)(Week 9 to Week 21 or End of Treatment (early termination))
- Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale(Week 21, LOCF)
- Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21(Week 21 or End of Treatment (early termination))
- Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period(Week 9 to Week 21 or End of Treatment (early termination))
- Percent of Seizure- Free Participants During the Treatment Observation Period(Week 9 to Week 21 or Early Termination (end of treatment))
- Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period(Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9))
- Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period(Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9))
- Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period(Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9))
- Treatment Satisfaction: Patient General Impression to Change (PGIC)(Week 21, LOCF)
- Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)(Week 21, LOCF)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS)(Week 21, LOCF)