1. Subjects diagnosed with RLS using the RLS Diagnostic Clinical Interview and the International RLS Study Group (IRLSSG) Diagnostic Criteria at the Screening Visit.
Item
1. Subjects diagnosed with RLS using the RLS Diagnostic Clinical Interview and the International RLS Study Group (IRLSSG) Diagnostic Criteria at the Screening Visit.
boolean
C0035258 (UMLS CUI [1])
C1537061 (UMLS CUI [2,1])
C0035258 (UMLS CUI [2,2])
2. Subjects > 18 years and < 80 years of age
Item
2. Subjects > 18 years and < 80 years of age.
boolean
C0001779 (UMLS CUI [1])
3. Restless Legs Syndrome; Frequencies (time pattern) | Restless Legs Syndrome; Pharmaceutical Preparations; Washout Period
Item
3. Subjects have had RLS symptoms with a history of a minimum of 20 evening and nights of RLS episodes during the month prior to the Screening Visit (e.g., any combination of evenings and/or nights for >20 days). In the case of a subject currently receiving medication for the treatment of RLS at the Screening Visit, this inclusion criterion can be waived. However, the subject must discontinue and washout any previous medication for the treatment of RLS or sleep prior to the Baseline Visit (Day 0). The minimum discontinuation period for washout is generally 5 half-lives of the medication or 7 consecutive nights medication-free prior to baseline, whichever is the longer period.
boolean
C0035258 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0035258 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1710661 (UMLS CUI [2,3])
4.During the Washout and Screening Phase, RLS symptoms must be present for at least 4 of the last 7 evening and nights immediately prior to the Baseline Visit (e.g., any combination of evenings and/or nights for >4 days).
Item
4.During the Washout and Screening Phase, RLS symptoms must be present for at least 4 of the last 7 evening and nights immediately prior to the Baseline Visit (e.g., any combination of evenings and/or nights for >4 days).
boolean
C1710661 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0220908 (UMLS CUI [2,1])
C0035258 (UMLS CUI [2,2])
C0439603 (UMLS CUI [2,3])
5.Subjects with a total score > 15 on the IRLS Rating Scale at baseline.
Item
5.Subjects with a total score > 15 on the IRLS Rating Scale at baseline.
boolean
C0449820 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
6.Subjects with RLS symptoms that cause significant sleep impairment based on clinical judgment and guided by subject response to question 4 of the IRLS Rating Scale (e.g., Ordinarily this will include a response of (3) severe or (4) very severe sleep disturbance) at the Baseline Visit.
Item
6.Subjects with RLS symptoms that cause significant sleep impairment based on clinical judgment and guided by subject response to question 4 of the IRLS Rating Scale (e.g., Ordinarily this will include a response of (3) severe or (4) very severe sleep disturbance) at the Baseline Visit.
boolean
C0035258 (UMLS CUI [1,1])
C0851578 (UMLS CUI [1,2])
7.Subjects must be experiencing RLS symptoms requiring treatment prior to bedtime, but no earlier than 5:00 PM.
Item
7.Subjects must be experiencing RLS symptoms requiring treatment prior to bedtime, but no earlier than 5:00 PM.
boolean
C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C0521112 (UMLS CUI [1,4])
8. Subjects must have given written informed consent prior to any specific study procedures.
Item
8. Subjects must have given written informed consent prior to any specific study procedures.
boolean
C0021430 (UMLS CUI [1])
1. Subjects requiring treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM).
Item
1. Subjects requiring treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM).
boolean
C0035258 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0332169 (UMLS CUI [1,4])
2. Signs of secondary RLS (e.g. end stage renal disease, iron deficient anemia or pregnancy at Baseline Visit).
Item
2. Signs of secondary RLS (e.g. end stage renal disease, iron deficient anemia or pregnancy at Baseline Visit).
boolean
C1261469 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
C0162316 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
3. Subjects with a serum ferritin level of < 10 mcg/L (ng/mL) that has not resolved by the time of the Baseline Visit.
Item
3. Subjects with a serum ferritin level of < 10 mcg/L (ng/mL) that has not resolved by the time of the Baseline Visit.
boolean
C0696113 (UMLS CUI [1])
Laboratory test result abnormal; Clinical Significance | Electrocardiogram abnormal; Clinical Significance | Physical Examination; Abnormal; Clinical Significance | Myocardial Ischemia | Abnormal cardiac conduction; Clinical Significance | Cardiac Arrhythmia; Clinical Significance
Item
4. Subjects having a clinically significant abnormal lab, ECG, or physical exam findings not resolved by time of baseline examinations. Abnormal 12-lead ECG findings include, but are not limited to the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias
boolean
C0438215 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0522055 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
C2826293 (UMLS CUI [3,3])
C0151744 (UMLS CUI [4])
C0232219 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0003811 (UMLS CUI [6,1])
C2826293 (UMLS CUI [6,2])
5. Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
Item
5. Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
boolean
C0236991 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0027404 (UMLS CUI [3])
C0851578 (UMLS CUI [4,1])
C0037320 (UMLS CUI [4,2])
C0037672 (UMLS CUI [5])
C0236845 (UMLS CUI [6])
6. Subjects diagnosed with movement disorders (e.g. Parkinson’s Disease, dyskinesias, and dystonias).
Item
6. Subjects diagnosed with movement disorders (e.g. Parkinson’s Disease, dyskinesias, and dystonias).
boolean
C0026650 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C0013384 (UMLS CUI [3])
C0013421 (UMLS CUI [4])
7. Subjects who have medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern.
Item
7. Subjects who have medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern. These may include, but are not limited to the following disorders: diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, pleuro-pulmonary fibrosis).
boolean
C0012634 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0036043 (UMLS CUI [2,3])
C2699424 (UMLS CUI [2,4])
C0011849 (UMLS CUI [3])
C0031117 (UMLS CUI [4])
C0003873 (UMLS CUI [5])
C0016053 (UMLS CUI [6])
C0740482 (UMLS CUI [7])
C0007222 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0035078 (UMLS CUI [9])
C0085605 (UMLS CUI [10])
C0034069 (UMLS CUI [11])
8.Subjects with augmentation and/or end-of-dose rebound symptoms at baseline.
Item
8.Subjects with augmentation and/or end-of-dose rebound symptoms at baseline. Augmentation is defined as RLS symptoms that occurred while on treatment and occur >2 hours earlier than they did before, symptoms which are more severe than when not treated, symptoms which start after less time at rest than they did before treatment, or symptoms which involve other parts of the body, such as the arms or trunk.
boolean
C1293122 (UMLS CUI [1])
C0549262 (UMLS CUI [2])
C0035258 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
C2745955 (UMLS CUI [3,3])
C0035258 (UMLS CUI [4,1])
C1457887 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C0035258 (UMLS CUI [5,1])
C1457887 (UMLS CUI [5,2])
C0229962 (UMLS CUI [5,3])
9. Subjects with a history of alcohol or substance abuse within the past year.
Item
9. Subjects with a history of alcohol or substance abuse within the past year.
boolean
C0085762 (UMLS CUI [1,1])
C1299544 (UMLS CUI [1,2])
10. Subjects with a diastolic blood pressure >110mmHg or <50mmHg or systolic blood pressure > 180mmHg or <90mmHg at the Screening or Baseline Visit.
Item
10. Subjects with a diastolic blood pressure >110mmHg or <50mmHg or systolic blood pressure > 180mmHg or <90mmHg at the Screening or Baseline Visit.
boolean
C0428883 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
11. Subjects taking any medication known to induce drowsiness, affect RLS or sleep and that have not been discontinued prior to the Baseline Visit.
Item
11. Subjects taking any medication known to induce drowsiness, affect RLS or sleep and that have not been discontinued prior to the Baseline Visit. These medications include the following: - antidepressants (tricyclic antidepressants, noradrenaline [norepinephrine]/ serotonin re-uptake inhibitors, selective serotonin re-uptake inhibitors, bupropion), anticonvulsants, opioids (including propoxyphene and oxycodone), anxiolytics, all sedatives/hypnotics (including benzodiazepines), lithium, oral neuroleptics, stimulants (including methylphenidate), antipsychotics, dopamine agonists, dopamine antagonists, clonidine, and sedating antihistamines (e.g. chlorpheniramine, diphenhydramine, hydroxyzine) or any preparations containing these antihistamines - The minimum discontinuation period is generally 5 half lives or 7 consecutive evening/nights medication free, prior to baseline, whichever is the longer period. Exceptions to this general rule are as follows: fluoxetine, monoamine oxidase inhibitors: 4 weeks; depot neuroleptics: 12 weeks. - Exceptions may be made in the case of subjects who have been taking stable doses of one of the excluded medications for at least 3 months prior to study start and it can be confirmed that the medication is not affecting the subject’s symptoms of RLS or sleep. These exceptions will be made on a case by case basis after consultation with the sponsor. For these exceptions, the dose of the excluded medication must remain stable throughout the duration of the study.
boolean
C0013227 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C0013227 (UMLS CUI [1,5])
C0013144 (UMLS CUI [1,6])
C0035258 (UMLS CUI [1,7])
C0037313 (UMLS CUI [1,8])
C0457454 (UMLS CUI [1,9])
C0003290 (UMLS CUI [2])
C0162758 (UMLS CUI [3])
C0003286 (UMLS CUI [4])
C0242402 (UMLS CUI [5,1])
C0033493 (UMLS CUI [5,2])
C0030049 (UMLS CUI [5,3])
C0040616 (UMLS CUI [6])
C0020592 (UMLS CUI [7,1])
C0005064 (UMLS CUI [7,2])
C0023870 (UMLS CUI [8])
C0040615 (UMLS CUI [9,1])
C0442027 (UMLS CUI [9,2])
C0304402 (UMLS CUI [10,1])
C0025810 (UMLS CUI [10,2])
C0040615 (UMLS CUI [11])
C0178601 (UMLS CUI [12])
C0242702 (UMLS CUI [13])
C0009014 (UMLS CUI [14])
C0360183 (UMLS CUI [15,1])
C0008281 (UMLS CUI [15,2])
C0012522 (UMLS CUI [15,3])
C0020404 (UMLS CUI [15,4])
C0457454 (UMLS CUI [16,1])
C1524031 (UMLS CUI [16,2])
C0016365 (UMLS CUI [17])
C0026457 (UMLS CUI [18])
C0040615 (UMLS CUI [19,1])
C0086129 (UMLS CUI [19,2])
12. Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacin, cimetidine, fluvoxamine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to Baseline Visit.
Item
12. Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacin, cimetidine, fluvoxamine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to Baseline Visit. Subjects already on these agents may be enrolled, but must remain on stable doses of the agents from 7 days prior to Baseline Visit through to the follow-up visit at end of study.
boolean
C0282402 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0282402 (UMLS CUI [2,1])
C0579004 (UMLS CUI [2,2])
C0282402 (UMLS CUI [3,1])
C1707811 (UMLS CUI [3,2])
C1827504 (UMLS CUI [4,1])
C0008809 (UMLS CUI [4,2])
C0008783 (UMLS CUI [4,3])
C0085228 (UMLS CUI [4,4])
C0282402 (UMLS CUI [4,5])
C1827490 (UMLS CUI [5,1])
C0543414 (UMLS CUI [5,2])
C0028978 (UMLS CUI [5,3])
13. Subjects who have exhibited intolerance to ropinirole or any other dopamine agonist.
Item
13. Subjects who have exhibited intolerance to ropinirole or any other dopamine agonist.
boolean
C1744706 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0178601 (UMLS CUI [2,2])
14. Night workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study.
Item
14. Night workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study.
boolean
C0555008 (UMLS CUI [1])
C0547101 (UMLS CUI [2,1])
C4698019 (UMLS CUI [2,2])
C0035171 (UMLS CUI [2,3])
C0547101 (UMLS CUI [3,1])
C4698019 (UMLS CUI [3,2])
C0680104 (UMLS CUI [3,3])
15. Participation in any clinical drug or device trial in the one month prior to the Baseline Visit.
Item
15. Participation in any clinical drug or device trial in the one month prior to the Baseline Visit.
boolean
C2348568 (UMLS CUI [1])
15. Subjects non-compliant with the visit schedule or other study procedures.
Item
15. Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule or other study procedures.
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
17. Women who have a positive pregnancy test or who are lactating.
Item
17. Women who have a positive pregnancy test or who are lactating.
boolean
C0032961 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
18. Women of child-bearing potential who are not practicing a clinically accepted method of contraception.
Item
18. Women of child-bearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (e.g. Norplant).
boolean
C1960468 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C3176353 (UMLS CUI [2,2])
C0029151 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6,1])
C3843423 (UMLS CUI [6,2])
C0009653 (UMLS CUI [6,3])
C0700589 (UMLS CUI [7,1])
C1515119 (UMLS CUI [7,2])