NCT00298623已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 222
- 主要终点
- The change from baseline to the end of treatment in International Restless Legs Syndrome (IRLS) rating scale score.
研究概览
简要总结
The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary RLS, based on the International RLS Study Group Diagnostic Criteria.
- •History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started;
- •Documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights during the Baseline study period;
- •Total RLS severity score of 15 or greater on the International Restless Legs Syndrome Study Group Rating Scale (IRLS rating scale) at Visit 1 and at Visit 2;
- •Discontinuation of dopamine agonists and/or gabapentin at least 2 weeks prior to Baseline;
- •Discontinuation of other treatments for RLS (e.g., opioids, benzodiazepines) at least 2 weeks prior to Baseline;
- •If female of child-bearing potential, the subject must agree to use clinically accepted birth control through completion of the study;
- •Body Mass Index of 34 or below;
- •Estimated creatinine clearance of at least 60 mL/min;
排除标准
- •A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
- •Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias, and dystonias);
- •Abnormal laboratory results, electrocardiogram (ECG) or physical findings;
- •Pregnant or lactating women;
- •Women of childbearing potential who are not practicing an acceptable method of birth control.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Other)
XP13512 (GSK1838262)
Experimental
干预措施: XP13512 (GSK1838262) (Drug)
结局指标
主要结局
The change from baseline to the end of treatment in International Restless Legs Syndrome (IRLS) rating scale score.
时间窗: 12-week treatment period
The proportion of subjects at the end of treatment who are "much improved" or "very much improved" on the Investigator-rated CGI of Improvement
时间窗: 12-week treatment period
次要结局
- Onset of efficacy. Subjective measures of sleep.(12-week treatment period)
研究者
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