1. Is the patient male or female and diagnosed with RLS using IRLSSG diagnostic criteria with a history of a minimum of 15 nights of RLS symptoms per month?
Item
1. Is the patient male or female and diagnosed with RLS using IRLSSG diagnostic criteria with a history of a minimum of 15 nights of RLS symptoms per month?
boolean
C0079399 (UMLS CUI [1])
C0035258 (UMLS CUI [2])
C2348561 (UMLS CUI [3,1])
C0679228 (UMLS CUI [3,2])
C0439603 (UMLS CUI [4])
2. Does the patient have a score of 15 or greater RLS Rating Scale at the baseline (Day 1) visit?
Item
2. Does the patient have a score of 15 or greater RLS Rating Scale at the baseline (Day 1) visit?
boolean
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
3. Is the patient aged between 18 and 79 years old, inclusive?
Item
3. Is the patient aged between 18 and 79 years old, inclusive?
boolean
C0001779 (UMLS CUI [1])
4. Does the patient have a body mass index (BMI = weight kg/height m2) within the range 19 to 29 kg.m-2?
Item
4. Does the patient have a body mass index (BMI = weight kg/height m2) within the range 19 to 29 kg.m-2?
boolean
C1305855 (UMLS CUI [1])
5. Has the patient given written informed consent prior to any specific study procedures being performed?
Item
5. Has the patient given written informed consent prior to any specific study procedures being performed?
boolean
C0021430 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
1. Does the patient suffer from RLS symptoms which require treatment during the daytime (daytime defined as 10:00 until 18:00)?
Item
1. Does the patient suffer from RLS symptoms which require treatment during the daytime (daytime defined as 10:00 until 18:00)?
boolean
C1457887 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0332169 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
2. Does the patient suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleep walking disorder and breathing related sleep disorder)?
Item
2. Does the patient suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleep walking disorder and breathing related sleep disorder)?
boolean
C0236991 (UMLS CUI [1])
C0035258 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0035258 (UMLS CUI [3,2])
C0027404 (UMLS CUI [4])
C0851578 (UMLS CUI [5])
C0037672 (UMLS CUI [6])
C1260922 (UMLS CUI [7,1])
C0037313 (UMLS CUI [7,2])
C0439849 (UMLS CUI [7,3])
3. Does the patient have signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anaemia or pregnancy at baseline)?
Item
3. Does the patient have signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anaemia or pregnancy at baseline)?
boolean
C1536279 (UMLS CUI [1])
C0035078 (UMLS CUI [2])
C0022661 (UMLS CUI [3])
C0162316 (UMLS CUI [4])
C0032961 (UMLS CUI [5])
4. Does the patient suffer from movement disorders (e.g. Parkinson’s disease, dyskinesias, and dystonias)?
Item
4. Does the patient suffer from 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])
5. Pharmaceutical Preparations | Drowsiness | Restless Legs Syndrome | Sleep | Discontinuation (procedure); Baseline; Before
Item
5. Is the patient taking any medication known to induce drowsiness, affect RLS or sleep? (The minimum discontinuation period is 5 half lives or 5 consecutive nights medication free, prior to baseline, whichever is the longer period.)
boolean
C0013227 (UMLS CUI [1])
C0013144 (UMLS CUI [2])
C0035258 (UMLS CUI [3])
C0037313 (UMLS CUI [4])
C0457454 (UMLS CUI [5,1])
C1442488 (UMLS CUI [5,2])
C0332152 (UMLS CUI [5,3])
6. Does the patient have diastolic blood pressure ≥110mmHg or ≤ 50mmHg OR systolic blood pressure ≥ 180mmHg or ≤ 90mmHg at baseline (Day 1 pre-dose)?
Item
6. Does the patient have diastolic blood pressure ≥110mmHg or ≤ 50mmHg OR systolic blood pressure ≥ 180mmHg or ≤ 90mmHg at baseline (Day 1 pre-dose)?
boolean
C0428883 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C1442488 (UMLS CUI [3])
7. Does the patient have a history or presence of symptomatic orthostatic hypotension?
Item
7. Does the patient have a history or presence of symptomatic orthostatic hypotension?
boolean
C0740482 (UMLS CUI [1])
8. OTC - Over The Counter; Pharmaceutical Preparations | Before; Medication dose; First (number)
Item
8. Has the patient received over-the-counter (OTC) medicine within 48 hours before the first dose of study drug? (Patients who have taken OTC medication may still be entered in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety)
boolean
C2709201 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C3174092 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
9. Has the patient exhibited intolerance to ropinirole or any dopamine agonist?
Item
9. Has the patient exhibited intolerance to ropinirole or any dopamine agonist?
boolean
C1744706 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C0178601 (UMLS CUI [2])
10. Childbearing Potential | Contraceptive methods | Oral contraception | Female Sterilization | Intrauterine Devices | Vaginal contraceptive diaphragm (device); Spermicidal foam or jelly; condom use | Contraceptive methods; systemic therapy | Norplant
Item
10. Is the patient a women of child-bearing potential who is not practising a clinically accepted method of contraception such as oral contraception, surgical sterilisation, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant)?
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0029151 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6,1])
C3843423 (UMLS CUI [6,2])
C0679782 (UMLS CUI [6,3])
C0700589 (UMLS CUI [7,1])
C1515119 (UMLS CUI [7,2])
C1145675 (UMLS CUI [8])
11. Is the patient a female of child bearing potential who has a positive pregnancy test or who is lactating at screening or day 1 visit?
Item
11. Is the patient a female of child bearing potential who has a positive pregnancy test or who is lactating at screening or day 1 visit?
boolean
C3831118 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0220908 (UMLS CUI [4])
12. DSM-IV; Alcohol abuse | DSM-IV; Drug abuse | Substance Dependence | alcohol units/day | alcohol units/week
Item
12. Does the patient meet DSM-IV criteria for substance ’abuse’ (alcohol or drugs) or substance ’dependence’ within 6 months prior to screening? (abuse of alcohol defined as an intake of grater than 3 units per day or 21 units per week for male or 2 units per day or 14 units per week for females. (one unit is equivalent to half pint of beer, one measure of sprits or one small glass of wine)
boolean
C0220952 (UMLS CUI [1,1])
C0085762 (UMLS CUI [1,2])
C0220952 (UMLS CUI [2,1])
C0013146 (UMLS CUI [2,2])
C0038580 (UMLS CUI [3])
C0560578 (UMLS CUI [4])
C0560579 (UMLS CUI [5])
13. Gastrointestinal Diseases | Liver diseases | Kidney Diseases | Other medical condition | Interferes with; drug absorption | C0521102 Interferes with; drug distribution (pharmacokinetics) | Interferes with; drug metabolism | Interferes with; drug elimination
Item
13. Does the patient have a history or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs?
boolean
C0017178 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C3843040 (UMLS CUI [4])
C0521102 (UMLS CUI [5,1])
C0678745 (UMLS CUI [5,2])
C0521102 (UMLS CUI [6,1])
C0699903 (UMLS CUI [6,2])
C0521102 (UMLS CUI [7,1])
C0683140 (UMLS CUI [7,2])
C0521102 (UMLS CUI [8,1])
C0683141 (UMLS CUI [8,2])
14. Physical Examination; Abnormality | risk factors | Interferes with
Item
14. Does the patients have an abnormality on physical examination? A patient with a clinical abnormality may be included only if the Investigator considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
boolean
C0031809 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2])
C0521102 (UMLS CUI [3])
15. Chemistry, Clinical; Hematologic Tests; Abnormality | Laboratory test finding; Normal Range | Age | risk factors
Item
15. Does the patient have an abnormality on clinical chemistry of haematology examination at screening? (Patients with laboratory parameters outside the reference range for this age group will only be included if the Investigator considers that such findings will not introduce additional risk factors)
boolean
C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C0086715 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C0035648 (UMLS CUI [4])
16. 12 lead ECG; Abnormality | risk factors; Interferes with
Item
16. Does the patient have an abnormal 12 lead ECG at the screening visit? A patient with an abdominal ECG trace may be included only if the Investigator considers that the abnormality will not introduce additional risks factors and will not interfere with study procedures.
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
17. Does the patient have a positive urine test for drugs of abuse at screening?
Item
17. Does the patient have a positive urine test for drugs of abuse at screening?
boolean
C0202274 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
18. Will the patient, in the opinion of the Investigator, be non-compliant with the visit schedule or other study procedures?
Item
18. Will the patient, in the opinion of the Investigator, be non-compliant with the visit schedule or other study procedures?
boolean
C0457432 (UMLS CUI [1])
C0545082 (UMLS CUI [2,1])
C0086960 (UMLS CUI [2,2])
C2700391 (UMLS CUI [3])
19. Has the patient participated in a clinical trial with any drug within 3 months before the screening visit?
Item
19. Has the patient participated in a clinical trial with any drug within 3 months before the screening visit?
boolean
C2348568 (UMLS CUI [1])
20. Does the patient have positive hepatitis B surface antigen, hepatitis C antibodies and HIV - I/II antibody results at screening?
Item
20. Does the patient have positive hepatitis B surface antigen, hepatitis C antibodies and HIV - I/II antibody results at screening?
boolean
C0019168 (UMLS CUI [1])
C0166049 (UMLS CUI [2])
C0019683 (UMLS CUI [3])
21. Withdraw (activity) | Hormone replacement therapy; Introduction - action | Hormone replacement therapy; Changed status | Drug inhibition of cytochrome p450 CYP1A2 enzyme | Drug induction of cytochrome p450 CYP1A2 enzyme
Item
21. Has there been a withdrawal, introduction or change in dose hormone replacement therapy (HRT) and/or any drug known to substantiality inhibit or induce CYPIA2 within 7 days prior to first dose?
boolean
C2349954 (UMLS CUI [1])
C0282402 (UMLS CUI [2,1])
C0579004 (UMLS CUI [2,2])
C0282402 (UMLS CUI [3,1])
C0443172 (UMLS CUI [3,2])
C1827504 (UMLS CUI [4])
C1827490 (UMLS CUI [5])
22. Is the patient taking fluctuating doses of oestrogen in both HRT or oral contraception?
Item
22. Is the patient taking fluctuating doses of oestrogen in both HRT or oral contraception?
boolean
C0279494 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
C0231241 (UMLS CUI [1,3])
C0282402 (UMLS CUI [2])
C0029151 (UMLS CUI [3])
23. Will participation in this study result in the patient having donated more than 1500mL blood in the previous 12 months?
Item
23. Will participation in this study result in the patient having donated more than 1500mL blood in the previous 12 months?
boolean
C0005794 (UMLS CUI [1])