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, Age of Onset
Item
How old was the patient at the onset of RLS?
integer
C0035258 (UMLS CUI [1,1])
C0206132 (UMLS CUI [1,2])
Restless Legs Syndrome, Pharmaceutical Preparations, Relationships
Item
Did the patient start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
boolean
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Restless Legs Syndrome, Pharmaceutical Preparations, Relationships
Item
If ’Yes’ please specify medication(s)
text
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
If female, did RLS symptoms develop during pregnancy?
text
C0035258 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Code List
If female, did RLS symptoms develop during pregnancy?
CL Item
Not applicable (3)
Limb movement, Sleep
Item
Has the patient ever had PLMS (Periodic Limb Movements during Sleep)?
boolean
C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
Limb movement, Sleep, Age of Onset
Item
How old was the patient at the onset of PLMS?
integer
C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0206132 (UMLS CUI [1,3])
Alcohol consumption
Item
Does the patient drink alcohol?
boolean
C0001948 (UMLS CUI [1])
Alcohol consumption, alcohol units/week
Item
Units/week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Caffeine consumption
Item
Does the patient drink caffeine (coffee, tea, caffeinated drinks)?
boolean
C0948365 (UMLS CUI [1])
Caffeine consumption, cups of coffee consumed per day (___cups/day)
Item
Cups/day
integer
C0948365 (UMLS CUI [1,1])
C2164136 (UMLS CUI [1,2])
Sleep Disorders
Item
Does the patient have any sleep disorder as defined by DSM IV?
boolean
C0851578 (UMLS CUI [1])
Item
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
text
C0035258 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
Code List
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
Item
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of PLMS?
text
C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
Code List
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of PLMS?
Item
Are the patient’s current symptoms mainly present ...
text
C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0439548 (UMLS CUI [1,3])
Code List
Are the patient’s current symptoms mainly present ...
CL Item
At nightime only (1)
CL Item
In evening and nightime (2)
CL Item
Daytime, evening and nightime (3)
Restless Legs Syndrome, limb movement, desire; Restless Legs Syndrome, Paresthesia; Restless Legs Syndrome, Dysesthesia
Item
The International RLS Study Group Criteria* defines RLS patients as having a desire to move the limbs usually associated with paresthesias or dysesthesias.
boolean
C0035258 (UMLS CUI [1,1])
C0596840 (UMLS CUI [1,2])
C0871633 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2,1])
C0030554 (UMLS CUI [2,2])
C0035258 (UMLS CUI [3,1])
C0392699 (UMLS CUI [3,2])
Restless Legs Syndrome, Motor Restlessness
Item
The International RLS Study Group Criteria* defines RLS patients as having motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort).
boolean
C0035258 (UMLS CUI [1,1])
C0700075 (UMLS CUI [1,2])
Restless Legs Syndrome, Symptoms, Rest; Restless Legs Syndrom, Physical activity, Feeling relief
Item
The International RLS Study Group Criteria* defines RLS patients as having symptoms worse or exclusively present at rest with at least partial and temporal relief by activity
boolean
C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0035253 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2,1])
C0026606 (UMLS CUI [2,2])
C0564405 (UMLS CUI [2,3])
Restless Legs Syndrome, Symptoms, Temporal periods of day
Item
The International RLS Study Group Criteria* defines RLS patients as having symptoms worse in the evening or night.
boolean
C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0439548 (UMLS CUI [1,3])
Item
Height (without shoes)
text
C0005890 (UMLS CUI [1])
Code List
Height (without shoes)
Body Height
Item
Height (without shoes)
float
C0005890 (UMLS CUI [1])
Item
Weight (without shoes)
text
C0005910 (UMLS CUI [1])
Code List
Weight (without shoes)
Body Weight
Item
Weight (without shoes)
float
C0005910 (UMLS CUI [1])
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) - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Semi-erect; Vital Signs Time
Item
After 10 minutes semi-supine - Time Vitals Taken
time
C0522019 (UMLS CUI [1,1])
C2826762 (UMLS CUI [1,2])
Semi-erect; Systolic Pressure
Item
After 10 minutes semi-supine - Blood Pressure (systolic)
integer
C0522019 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
Semi-erect; Diastolic blood pressure
Item
After 10 minutes semi-supine - Blood Pressure (diastolic)
integer
C0522019 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Semi-erect; Heart rate
Item
After 10 minutes semi-supine - Pulse
integer
C0522019 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Erect, Vital Signs Time
Item
After erect for 1 minute - Time Vitals Taken
time
C0522014 (UMLS CUI [1,1])
C2826762 (UMLS CUI [1,2])
Erect, Systolic Pressure
Item
After erect for 1 minute - Blood Pressure (systolic)
integer
C0522014 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
Erect, Diastolic blood pressure
Item
After erect for 1 minute - Blood Pressure (diastolic)
integer
C0522014 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Erect, Heart rate
Item
After erect for 1 minute - Pulse
integer
C0522014 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
12 lead ECG, Date in time
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
12 lead ECG, Abnormality
Item
Were any clinically significant abnormalities detected?
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Collection of blood specimen for laboratory procedure, Date in time
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory Procedures, Laboratory specimen identification label
Item
Please affix the Quest Diagnostics Laboratory label here.
text
C0022885 (UMLS CUI [1,1])
C4273937 (UMLS CUI [1,2])
Laboratory Procedures, Abnormality
Item
Were any clinically significant abnormalities detected?
boolean
C0022885 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
What was the result of the urine dipstick performed at this visit?
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
What was the result of the urine dipstick performed at this visit?
Childbearing Potential
Item
Is the patient a female of child-bearing potential?
boolean
C3831118 (UMLS CUI [1])
Item
If ’Yes’, please perform a pregnancy dipstick test and record result below.
text
C0430056 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
If ’Yes’, please perform a pregnancy dipstick test and record result below.
Medical History, History of surgical procedures
Item
Is the patient suffering from or has he/she ever suffered from any significant medical or surgical condition?
boolean
C0262926 (UMLS CUI [1,1])
C0489540 (UMLS CUI [1,2])
Medical History, Diagnosis; History of surgical procedures, Diagnosis
Item
Diagnosis (Only in the absence of a diagnosis, record the signs and symptoms on separate lines.)
text
C0262926 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
Medical History, Diagnosis, Year; History of surgical procedures, Diagnosis, Year
Item
Year of first diagnosis (if known)
integer
C0262926 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,3])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0439234 (UMLS CUI [2,3])
Item
Past / Ongoing
integer
C0262926 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C1444637 (UMLS CUI [1,4])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
C1444637 (UMLS CUI [2,4])
Pharmaceutical Preparations
Item
Has the patient taken any medication (excluding any pharmacotherapy medication for treatment of RLS) in the 3 months prior to study entry?
boolean
C0013227 (UMLS CUI [1])
Pharmaceutical Preparations, Medication name
Item
Drug Name (Trade Name Preferred)
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Pharmaceutical Preparations, Daily Dose, Total
Item
Total Daily Dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Pharmaceutical Preparations, Disease
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0013227 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Pharmaceutical Preparation, Start Date
Item
Start Date (be as precise as possible)
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Pharmaceutical Preparation, End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Pharmaceutical Preparations, Continuous
Item
Continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Restless Legs Syndrome, Pharmaceutical Preparations, Medical History
Item
Has the patient taken any pharmacotherapy medication for treatment of RLS?
boolean
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Restless Legs Syndrome, Pharmaceutical Preparations, Medication name
Item
Drug Name (Trade Name Preferred)
text
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Restless Legs Syndrome, Pharmaceutical Preparations, Start Date
Item
Start Date (be as precise as possible)
date
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Restless Legs Syndrome, Pharmaceutical Preparations, End Date
Item
End Date
date
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Restless Legs Syndrome, Pharmaceutical Preparations, Continuous
Item
Continuing
boolean
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Item
Did the patient respond to the treatment? (mark one)
text
C0035258 (UMLS CUI [1,1])
C0150839 (UMLS CUI [1,2])
Code List
Did the patient respond to the treatment? (mark one)
Item
Did the patient tolerate the treatment? (mark one)
text
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0556444 (UMLS CUI [1,3])
Code List
Did the patient tolerate the treatment? (mark one)
Restless Legs Syndrome, Diagnosis
Item
Inclusion - Patients diagnosed with RLS using IRLSSG diagnostic criteria with a history of a minimum of 15 nights of RLS symptoms during the previous month. In the case of a patient currently receiving medication for the treatment of RLS, the investigator should use his/her best clinical judgement to assess whether that patient would have suffered from a minimum of 15 nights with RLS symptoms if they had not been taking any medication.
boolean
C0035258 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Age
Item
Inclusion - Patient is ≥ 18 years old and < 80 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
Inclusion - Patient has given written informed consent prior to any specific study procedures.
boolean
C0021430 (UMLS CUI [1])
Restless Legs Syndrome, Daytime
Item
Exclusion - Patient is suffering from RLS symptoms which require treatment during the daytime (daytime defined as 10.00 until 18.00).
boolean
C0035258 (UMLS CUI [1,1])
C0332169 (UMLS CUI [1,2])
Primary Sleep Disorders
Item
Exclusion - Patient suffers 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])
Movement Disorders
Item
Exclusion - Patient is suffering from a movement disorder (e.g. Parkinson's Disease, dyskinesias or dystonias).
boolean
C0026650 (UMLS CUI [1])
Disease
Item
Exclusion - Patient has medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, etc.).
boolean
C0012634 (UMLS CUI [1])
Ropinirole, Intolerance to substance; Dopamine Agonists, Intolerance to substance
Item
Exclusion - Patient has exhibited intolerance to ropinirole or any other dopamine agonist
boolean
C0244821 (UMLS CUI [1,1])
C1744706 (UMLS CUI [1,2])
C0178601 (UMLS CUI [2,1])
C1744706 (UMLS CUI [2,2])
Substance Use Disorders; Substance Dependence
Item
Exclusion - Patient meets DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 6 months prior to Screening.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Female, Childbearing Potential, Contraceptive methods
Item
Exclusion - Patient is a woman, of child-bearing potential and is not practising a clinically accepted method of contraception such as oral contraception, surgical sterilisation, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant).
boolean
C0086287 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Female, Pregnancy; Female, Breast Feeding
Item
Exclusion - Patient is a woman who has a positive pregnancy test or is lactating.
boolean
C0086287 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0086287 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
Disease
Item
Exclusion - Patient has clinically significant or unstable medical conditions which in the opinion of the investigator would render the patient unsuitable for the study (e.g., symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, etc.).
boolean
C0012634 (UMLS CUI [1])
Non-Compliance
Item
Exclusion - Patient who, in the opinion of the Investigator, would be non-compliant with the visit schedule or other study procedures.
boolean
C0457432 (UMLS CUI [1])