NCT00996944.

Methods	Parallel RCT Subjects completing the screening period will be randomised (1:1) to receive ropinirole immediate release (IR) or placebo for 12 weeks.
Participants	Male and female patients aged 18 to 79 years Inclusion criteria at week ‐1 (at the screening visit): patients who are diagnosed with symptomatic restless legs syndrome associated with CKD managed with haemodialysis. RLS are diagnosed based on the IRLSSG diagnostic criteria.QTc criteria. Patients with QTc < 450 msec or < 480 msec for patients with bundle branch block Exclusion criteria at week ‐1 (at the screening visit): signs of primary RLS; sleep disorder not associated with RLS (narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder; complication of movement disorder; severe hepatic/cardiac/pulmonary disorder or haematopoietic disorder other than those on haemodialysis (including haemofiltration and haemodiafiltration); history of malignancies within the past 5 years, with the exception of basal cell carcinoma or carcinoma in situ of cervix; medical history or complication of substance abuse; supine systolic blood pressure(SBP) < 100 mm Hg or >190 mm Hg or supine diastolic blood pressure (DBP) ≥ 120 mm Hg before the dialysis; intolerant to ropinirole hydrochloride (HCl) or other dopamine agonists or ropinirole HCl or other dopamine agonists are considered to be of safety concern by the investigator/sub‐investigator; history of augmentation or end‐of‐dose‐rebound in the early morning after medications of dopamine agonists (including ropinirole HCl) and/or L‐dopa; without night time sleeping habit (e.g. night‐shift worker) and those who must drastically change the habitual bedtime during the study duration; participated in another clinical study of an investigational product or medical device within the last 12 weeks prior to the start of the screening period; pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study; current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones); presence of HBsAG, positive hepatitis C test result within 3 months of screening; medical conditions which could affect efficacy and safety assessment; unable to discontinue prohibited medications during the screening period; will imminently receive a transplant; changed the dose or administration method of anxiolytics or hypnotics and sedatives within the last 4 weeks prior to the start of the screening period, and/or patients who used more than two drugs; others whom the investigator/sub‐investigator considers ineligible for the study. Exclusion criteria at week 0 (start of the treatment period): supine SBP of < 100 mm Hg or > 190 mm Hg or supine DBP of ≥120 mm Hg before the dialysis at Week 0; started treatment with medications including an oestrogen drug product, anxiolytics, hypnotics and sedatives or who have changed the dose or administration method of such medications between week ‐1 (start of the screening period) and week 0 (start of the treatment period); serum ferritin level is < 10 μg/L (ng/mL) at the screening visit
Interventions	Treatment group The treatment with IR will be started at the initial dose of 0.25 mg/d within 1 to 3 hours before bedtime. The maximum available dose is 3 mg/d. For all subjects completing short‐term period and entering the long‐term treatment period, the open‐label treatment will be started from IR 0.25 mg/d regardless of dose levels during short‐term period. The dose will be upward titrated from 0.25 mg/d to 0.5 mg/d and after that in increments of 0.5 mg/d until sufficient efficacy is obtained (targeting "much improved" or "very much improved" in the CGI‐Improvement scores without safety/tolerability problem Control group Matching placebo to IR in the double‐blind treatment period. All participants completing the double‐blind treatment period were eligible to continue in the open‐label long‐term treatment period. In the open‐label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR‐ropinirole IR group.
Outcomes	IRLS rating scale at week 0 and week 12 Number with the indicated CGI‐improvement scores at week 12 RLS‐QOL PSQI Mean daily number of hours of RLS symptoms Drug clearance rate on‐dialysis and off‐dialysis
Notes	This study was prematurely terminated after 5 months had passed since its initiation, because GlaxoSmithKline concluded that it was impossible to recruit sufficient participants within a reasonable timeframe. In this study, no participants had completed. The maximum duration was 24 weeks plus follow‐up (up to week 64) Some data available on ClinicalTrials.gov