NCT00627003已完成3 期
A Double-blind, Randomized, Placebo-controlled Multicenter Efficacy Study for the Treatment of Patients With Restless Legs Syndrome (RLS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 43
- 主要终点
- Sleep efficiency
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with RLS. Also, additional objective and subjective sleep parameters and quality of life will be assessed.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic RLS
- •Moderate to severe symptoms as indicated by an IRLS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4
- •In a baseline polysomnography, patients had to have periodic leg movements during sleep arousal index greater than 5/hour of total sleep time
排除标准
- •Patients suffering from seconadry RLS, due to causes such as iron deficiency or renal disease, or suffering from secondary RLS while taking drugs suspected of causing secondary forms of RLS
研究组 & 干预措施
1
Experimental
干预措施: Cabergoline (Drug)
2
Experimental
干预措施: Placebo (Other)
结局指标
主要结局
Sleep efficiency
时间窗: Week 5
PLMS-arousal index (PLMS-AI)
时间窗: Week 5
次要结局
- Sleep Questionnaire Form A(Weeks 2 and 5)
- Quality of Life for RLS questionnaire(Weeks 2 and 5)
- Clinical Global Impressions(Weeks 2 and 5)
- Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography(Weeks 2 and 5)
- Total score of the severity rating scale of the International RLS (IRLS) Study Group(Weeks 2 and 5)
- RLS-6 severity scales(Weeks 2 and 5)
研究者
相似试验
已完成
3 期
A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLSRestless Legs SyndromeNCT00625547Pfizer361
终止
4 期
Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.Parkinson DiseaseNCT00174239Pfizer220
已完成
3 期
Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS BiomarkersOvarian Hyperstimulation SyndromeNCT01535859KK Women's and Children's Hospital46
已完成
1 期
A Pilot Study of Cabergoline for the Treatment of Cocaine DependenceCocaine DependenceCocaine AbuseCocaine AddictionSubstance AbuseNCT01651364Baylor College of Medicine11
已完成
3 期
24 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus and HypertensionHypertensionDiabetes Mellitus, Type 2NCT02182830Boehringer Ingelheim166