NCT00676403已完成2 期
Randomized, Double-Blind, 6-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6
研究概览
简要总结
To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe idiopathic RLS
- •symptoms occur predominantly in the evening
- •symptoms interfere with sleep onset or maintenance
排除标准
- •Any secondary RLS
- •require treatment for daytime RLS symptoms
- •symptomatic neuropathies
研究组 & 干预措施
1
Placebo Comparator
Placebo
干预措施: placebo (Drug)
2
Experimental
investigational treatment
干预措施: Pregabalin (Drug)
3
Experimental
investigational treatment
干预措施: Pregabalin (Drug)
4
Experimental
investigational treatment
干预措施: Pregabalin (Drug)
5
Experimental
investigational treatment
干预措施: Pregabalin (Drug)
6
Experimental
investigational treatment
干预措施: Pregabalin (Drug)
结局指标
主要结局
Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6
时间窗: Baseline, Week 6
IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline.
次要结局
- Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)(Week 6)
- Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6)
- Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline(Baseline, Week 1, Week 2, Week 4, Week 6)
- Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline(Baseline, Week 1, Week 2, Week 4, Week 6)
- Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline(Baseline, Week 1, Week 2, Week 4, Week 6)
- Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6)
- Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)(Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF))
- Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6)
- Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6)
- Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline(Baseline, Week 1, Week 2, Week 4, Week 6)
- Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline(Baseline, Week 1, Week 2, Week 4, Week 6)
- Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6)
- Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline(Baseline, Week 1, Week 2, Week 4, Week 6)
- Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline(Baseline,, Week 1, Week 2, Week 4, Week 6)
- Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline(Baseline,, Week 1, Week 2, Week 4, Week 6)
- Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week(Week 1, Week 2, Week 4, Week 6)
- Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6(Baseline, Week 6)
- Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6(Baseline, Week 6)
- Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores(Baseline, Week 6)
研究者
研究点 (1)
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