A 4-Week, Randomized, Double-Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting From Ropinirole Immediate Release (IR) to Ropinirole Controlled Release for RLS (CR-RLS) Formulation (Formerly Ropinirole Extended Release [XR]) in Patients With Restless Legs Syndrome (RLS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period
研究概览
简要总结
This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for 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
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
- •Diagnosis of RLS using IRLS Study Group (IRLSSG) diagnostic criteria.
- •Subjects currently being treated for RLS with a stable dose (for at least 2 weeks) of ropinirole IR given once daily.
- •Subjects with RLS symptoms during both the evening and night or night time only.
- •Subjects who have given written informed consent to participate.
排除标准
- •Subjects who require treatment of daytime RLS symptoms.
- •Signs of secondary RLS, serum ferritin level less than 10 mcg/L.
- •Movement Disorders, Clinically significant or unstable medical conditions.
- •Abnormal labs, electrocardiogram (ECG) or physical findings.
- •Receiving prohibited medications.
- •Sleeping habits incompatible with study design.
- •Intolerance to ropinirole or other dopamine agonist.
- •Pregnant or lactating.
- •Women of child-bearing potential who are not practicing an acceptable method of birth control.
研究组 & 干预措施
Ropinirole cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR
Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg controlled release for Restless Legs Syndrome (CR-RLS) in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.
干预措施: Ropinirole IR 1 mg (Drug)
Ropinirole cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR
Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg controlled release for Restless Legs Syndrome (CR-RLS) in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.
干预措施: Ropinirole IR 1 mg Placebo (Drug)
Ropinirole cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR
Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg controlled release for Restless Legs Syndrome (CR-RLS) in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.
干预措施: Ropinirole CR 2 mg (Drug)
Ropinirole cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR
Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg controlled release for Restless Legs Syndrome (CR-RLS) in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.
干预措施: Ropinirole CR 2 mg Placebo (Drug)
Ropinirole cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS
Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
干预措施: Ropinirole IR 1 mg (Drug)
Ropinirole cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS
Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
干预措施: Ropinirole IR 1 mg Placebo (Drug)
Ropinirole cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS
Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
干预措施: Ropinirole CR 2 mg (Drug)
Ropinirole cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS
Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
干预措施: Ropinirole CR 2 mg Placebo (Drug)
Ropinirole cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR
Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.
干预措施: Ropinirole IR 2 mg (Drug)
Ropinirole cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR
Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.
干预措施: Ropinirole IR 2 mg Placebo (Drug)
Ropinirole cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR
Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.
干预措施: Ropinirole CR 3 mg (Drug)
Ropinirole cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR
Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.
干预措施: Ropinirole CR 3 mg Placebo (Drug)
Ropinirole cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS
Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
干预措施: Ropinirole IR 2 mg (Drug)
Ropinirole cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS
Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
干预措施: Ropinirole IR 2 mg Placebo (Drug)
Ropinirole cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS
Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
干预措施: Ropinirole CR 3 mg (Drug)
Ropinirole cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS
Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
干预措施: Ropinirole CR 3 mg Placebo (Drug)
Ropinirole cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR
Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.
干预措施: Ropinirole IR 2 mg (Drug)
Ropinirole cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR
Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.
干预措施: Ropinirole IR 2 mg Placebo (Drug)
Ropinirole cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR
Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.
干预措施: Ropinirole CR 3 mg (Drug)
Ropinirole cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR
Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.
干预措施: Ropinirole CR 3 mg Placebo (Drug)
Ropinirole cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS
Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
干预措施: Ropinirole IR 2 mg (Drug)
Ropinirole cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS
Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
干预措施: Ropinirole IR 2 mg Placebo (Drug)
Ropinirole cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS
Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
干预措施: Ropinirole CR 3 mg (Drug)
Ropinirole cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS
Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
干预措施: Ropinirole CR 3 mg Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period
时间窗: Up to 5 weeks
AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. In each of the 6 cohorts, there were 2 conversions, one of which was IR to CR-RLS and the other one IR to IR. Two populations were defined: the first conversion population and the second conversion population. The first conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 1 period and during the post-conversion 1 period. The second conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 2 period and during the post-conversion 2 period.
次要结局
- Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion(Up to 4 weeks)
- Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion(Up to 5 weeks)
- Number of Participants With SAEs and Severity of AEs(Up to 5 weeks)
- Change From Pre-conversion in Pulse Rate to One Week Post-conversion(Up to 5 weeks)
- Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion(Up to 5 weeks)
- Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC)(Up to 5 weeks)
- Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure(Up to 5 weeks)
- Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS(Up to 5 weeks)