A 13-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150-600 Mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Central Post-Stroke Pain (CPSP)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)
研究概览
简要总结
Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Positive history of clinical stroke at least 4 months prior to randomization CPSP--3 months prior to screening
排除标准
- •History of dementia or any other severe cognitive impairment
- •Diabetic Peripheral Neuropathy (DPN)
研究组 & 干预措施
Pregabalin
The change from in pain scores from baseline to endpoint among stroke subjects receiving pregabalin will be compared to change in pain scores from baseline to endpoint among stroke subjects receiving matched placebo.
干预措施: Pregabalin (Drug)
Placebo
The change in pain scores from baseline to endpoint will be compared among the two treatment groups- ie subjects receiving 12 weeks of pregabalin treatment vs subjects receiving 12 weeks of placebo treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)
时间窗: Up to Week 12
Mean pain score obtained from last 7 available DPRS scores up to and including day of Week 12 visit or early termination (ET) equivalent. DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.
次要结局
- Pain Score as Measured by DPRS(Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12)
- Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint(Baseline, Week 12)
- Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint(Baseline, Week 12)
- QANeP - Pain Rating Scales(Baseline, Week 12)
- Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])(Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12)
- Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only(Week 12)
- Neuropathic Pain Symptom Inventory (NPSI)(Week 12)
- Medical Outcome Study (MOS) Sleep Scale(Week 12)
- Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep(Week 12)
- Hospital Anxiety and Depression Scale (HADS) - ITT Population(Week 12)
- Euro Quality of Life (EQ-5D)- Health State Profile Utility Score(Week 12)
- EQ-5D - VAS(Week 12)
- Patient Global Impression of Change (PGIC)(Week 12)
- Clinical Global Impression of Change (CGIC)(Week 12)
- Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold(Baseline, Week 12)