Study Coordinating Center, Identification number
Item
Centre Number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Patient Number
integer
C2348585 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Restless Legs Syndrome, Score
Item
Inclusion - Patient has a total score ≥ 15 on the RLS Rating Scale at baseline.
boolean
C0035258 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Secondary Restless Legs Syndrome; Iron deficiency anemia; Pregnancy
Item
Exclusion - Signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anemia, or pregnancy at baseline.
boolean
C0035258 (UMLS CUI [1])
C0162316 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
Augmentation procedure; Rebound effect
Item
Exclusion - Patient suffers from augmentation and/or end of dose rebound at baseline.
boolean
C1293122 (UMLS CUI [1])
C0549262 (UMLS CUI [2])
Laboratory Procedures, Abnormality; ECG abnormality; Physical Examination, Abnormality
Item
Patient has a clinically significant abnormal lab, ECG or physical exam findings not resolved by time of baseline examinations.
boolean
C0022885 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1832603 (UMLS CUI [2])
C0031809 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
Pharmaceutical Preparations, Drowsiness, Relationships; Pharmaceutical Preparations, Restless Legs Syndrome, Relationships; Pharmaceutical Preparations, Sleep, Relationships
Item
Exclusion - Patient is taking any medication known to induce drowsiness, affect RLS or sleep (the minimum discontinuation period is generally 5 half lives or 7 consecutive nights medication free, prior to baseline, whichever is the longer period).
boolean
C0013227 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0035258 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0037313 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
Systolic Pressure; Diastolic blood pressure
Item
Exclusion - Patient has a diastolic blood pressure ≥ 110mmHg or ≤ 50mmHg OR systolic blood pressure ≥180mmHg or ≤ 90mmHg at baseline.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Study Subject Participation Status
Item
Exclusion - Patient has participated in any clinical drug or device trial in the three months prior to the baseline visit.
boolean
C2348568 (UMLS CUI [1])
Hormon Replacement Therapy; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 CYP1A2 Inhibitors
Item
Exclusion - Patient has had a withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrollment. Patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrollment through to the end of study.
boolean
C0282402 (UMLS CUI [1])
C3850050 (UMLS CUI [2])
C3850068 (UMLS CUI [3])
Heart rate
Item
Pulse (after 5 minutes sitting)
integer
C0018810 (UMLS CUI [1])
Systolic Pressure, Sitting position
Item
Sitting Blood Pressure (after 5 minutes sitting) - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Diastolic blood pressure, Sitting position
Item
Sitting Blood Pressure (after 5 minutes sitting) - Distolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
No signs/symptoms, Baseline
Item
Please mark this box if no baseline events occurred prior to randomisation into study.
boolean
C3846032 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Event, Baseline, Signs and Symptoms
Item
Baseline Event (please print clearly)
text
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
Event,Baseline, Date of onset, Time of onset
Item
Onset Date and Time
datetime
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
C0449244 (UMLS CUI [1,4])
Item
Outcome
text
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Event Course
text
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,3])
Event, Baseline, Number of Episodes
Item
Event Course Intermittent - No. of episodes
integer
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
Item
Intensity (maximum)
text
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Code List
Intensity (maximum)
Item
Relationship to study procedures performed prior to randomisation
text
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
Code List
Relationship to study procedures performed prior to randomisation
Event, Baseline, Therapeutic procedure
Item
Corrective Therapy
boolean
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Event, Baseline, Patient withdrawn from trial
Item
Was patient withdrawn due to this specific event?
boolean
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0422727 (UMLS CUI [1,3])
Item
Which one of the following categories best describes the patient at this time?
text
C0242271 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Code List
Which one of the following categories best describes the patient at this time?
CL Item
Full time employment (1)
CL Item
Part-time employment (2)
CL Item
Volunteer/Unpaid work (3)
CL Item
Unemployed due to RLS (4)
CL Item
Unemployed due to other (NON-RLS) disability (5)
CL Item
Unemployed for other reason (6)
Part-time Employment, Hours worked per week
Item
If Part-time employment - list approximate hours per week
integer
C0682294 (UMLS CUI [1,1])
C2584953 (UMLS CUI [1,2])
Volunteer work, Unpaid work, Hours worked per week
Item
If Volunteer/Unpaid work - list approximate hours per week
integer
C2367294 (UMLS CUI [1,1])
C0557361 (UMLS CUI [1,2])
C2584953 (UMLS CUI [1,3])
Retirement, Date in time
Item
If Retired - Date of retirement
date
C0035345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Please mark the one box below which best describes the category of the patient's occupation: (International Standard Classification of Occupations, ISCO-88 COM)
text
C0421456 (UMLS CUI [1])
Code List
Please mark the one box below which best describes the category of the patient's occupation: (International Standard Classification of Occupations, ISCO-88 COM)
CL Item
Legislator, senior official or manager (e.g. specialist managers, directors and chief executives) 2=Professional (e.g. teaching, legal, science and health professionals) (1)
CL Item
Technician or associate professional (computer associates, nurses/midwives, ship & aircraft controllers, police inspectors, finance & sales) (3)
CL Item
Clerk (e.g. secretaries, cashiers and other office clerks) (4)
CL Item
Service worker or shop and market sales worker (e.g. housekeeping and restaurant services, shop salesperson & demonstrators, and models) (5)
CL Item
Skilled agricultural or fishery worker (e.g. animal/crop producers, market gardeners, fishery workers, hunters and trappers) (6)
CL Item
Craft and related trades worker (e.g. miners, builders, blacksmiths, potters, glass-makers, textile workers) (7)
CL Item
Plant and machine operator or assembler (e.g. metal processing plant operators, food and related products machine operators) (8)
Randomization, Numbers
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Experimental drug, Containers, Identifier
Item
Container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])