NCT00363857已完成3 期
A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering From Restless Legs Syndrome (RLS)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 49
- 主要终点
- Improvement in RLS severity rating scale at Week 12
研究概览
简要总结
A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.
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
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Restless Legs Syndrome (RLS) with symptoms such as: uncomfortable or "creepy-crawly" sensations in your legs, overwhelming urge to move your legs to relieve these sensations, sensations go away when you move your legs, or trouble falling asleep or staying asleep because of these symptoms.
- •Patients must give written informed consent prior to any specific study procedures.
排除标准
- •Patients who suffer from narcolepsy, sleep terror disorder, sleepwalking disorder, or a breathing related sleep disorder.
- •Patients diagnosed with renal failure (end-stage renal disease) iron deficient anemia or pregnancy.
- •Patients suffering from other movement disorders (i.e. Parkinson's Disease).
- •Patients who have medical conditions such as diabetes, peripheral neuropathy, rheumatoid arthritis, or fibromyalgia syndrome.
- •Participation in any clinical drug or device trial in the last three months.
- •Other inclusion or exclusion criteria to be evaluated by the physician.
结局指标
主要结局
Improvement in RLS severity rating scale at Week 12
次要结局
- Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12.
研究者
研究点 (49)
Loading locations...
相似试验
已完成
3 期
A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)Restless Legs SyndromeNCT00225862GlaxoSmithKline140
已完成
4 期
12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs SyndromeRestless Legs Syndrome (RLS)Restless Legs SyndromeNCT00373542GlaxoSmithKline39
已完成
3 期
Ropinirole XR (Extended Release) In Patients With Restless Legs SyndromeRestless Legs SyndromeNCT00197080GlaxoSmithKline380
终止
3 期
Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02GastroparesisDiabetes MellitusNCT03426345Allergan311
终止
3 期
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01GastroparesisDiabetes MellitusNCT03285308Allergan336