NCT00288639已完成4 期
Lyrica (Pregabalin) Administered As An Add-On Therapy For Partial Seizures (LEADER) An Open-Label, Multicenter Add-On Therapy Trial
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.8 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2005年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 8
- 主要终点
- Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period
研究概览
简要总结
The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.
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
- •Outpatients equal to or greater than 18 years of age with diagnosis of epilepsy with partial seizures having minimum of two partial seizures during a two month period before the baseline visit
- •Having a clinical history of epilepsy and AED treatment at least 1 year prior to inclusion
排除标准
- •AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures
- •Having absences seizures
- •Having had status epileptics within the year prior to inclusion
- •Having a progressive neurological or systematic disorder
- •Having known significant renal or hepatic dysfunction
结局指标
主要结局
Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period
时间窗: 8 week baseline period & 12 week treatment observation period
Percentage change from baseline=\[(12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate)/ 8 week baseline period seizure frequency rate\] x 100. Seizure frequencies per 28-day period: = (total # of partial seizures in period x 28 / (total # of days in period).
次要结局
- Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period.(8 week baseline period and 21 week treatment period)
- Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between the 8 Week Baseline Period and 4 Week Intervals During the 21 Week Open-label Treatment Period.(8 week baseline period and 21 week treatment period)
- Number of Subjects Seizure-free(last 4 weeks & whole 12 week treatment observation period)
- Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period.(8 week baseline observation period & last 4 weeks of observation period)
- Subjects Achieving Seizure Freedom During Observation Period(Day 147 from the first dose of study drug)
- Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency(8 week baseline observation period & 12 week treatment observation period)
- Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC)(End of 21-week treatment)
- Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC)(End of 21-week treatment)
- Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores(Baseline, end of 21-week treatment)
- Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21.(Baseline, End of 21-week treatment)
- Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline(Baseline, End of 21-week treatment)
- Subjects Assessment of Optimal Sleep(Baseline, End of 21-week treatment)
研究者
研究点 (8)
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