0 Evaluaciones
ID

27188

Descripción

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Parkinson Disease Module: Screening

Palabras clave

Versiones (1)
  1. 3/11/17 3/11/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

3 de noviembre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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    GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188

    Inglés

    Screening

    1 formularios  
    1. StudyEvent: ODM
      1. Screening
    Screening
    Descripción

    Screening

    Alias
    UMLS CUI-1
    C1710477
    UMLS CUI-2
    C1516637
    UMLS CUI-3
    C0013893
    Centre Number
    Descripción

    Centre Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Patient Number
    Descripción

    Patient Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Descripción

    Patient Initials

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2986440
    Visit Date
    Descripción

    Visit Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    How old was the patient at the onset of RLS?
    Descripción

    age of onset restless legs syndrome

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C0206132
    Did the patient start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
    Descripción

    medication caused RLS

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0085978
    If ’Yes’ please specify medication(s)
    Descripción

    medication caused RLS

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0035258
    If female, did RLS symptoms develop during pregnancy?
    Descripción

    RLS symptoms develop during pregnancy

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C0032961
    UMLS CUI [1,3]
    C1457887
    Has the patient ever had PLMS (Periodic Limb Movements during Sleep)?
    Descripción

    PLMS

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0596840
    UMLS CUI [1,2]
    C0037313
    UMLS CUI [2]
    C0035258
    If 'Yes': How old was the patient at the onset of PLMS?
    Descripción

    age of onset of PLMS

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0206132
    UMLS CUI [1,2]
    C0596840
    UMLS CUI [1,3]
    C0037313
    UMLS CUI [2]
    C0035258
    Does the patient drink alcohol?
    Descripción

    alcohol consumption

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001948
    If 'Yes": Units/week
    Descripción

    One unit is equivalent to: US - 1.5oz hard liquor, 1 beer, 4oz wine UK - 1 measure spirits, 1/2 pt beer, 1 small glass of wine

    Tipo de datos

    integer

    Unidades de medida
    • Units/week
    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0560579
    Units/week
    Does the patient drink caffeine (coffee, tea, caffeinated drinks)?
    Descripción

    consumption of caffeine

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0948365
    If 'Yes': Cups/day
    Descripción

    consumption of caffeine

    Tipo de datos

    integer

    Unidades de medida
    • Cups/day
    Alias
    UMLS CUI [1]
    C0948365
    Cups/day
    Does the patient have any sleep disorder as defined by DSM IV?
    Descripción

    sleep disorder

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0851578
    UMLS CUI [1,2]
    C0220952
    Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
    Descripción

    first degree relative diagnosed with RLS

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1517194
    UMLS CUI [1,2]
    C0035258
    Are the patient’s current symptoms mainly present ...
    Descripción

    time symptoms present

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0035258
    UMLS CUI [1,3]
    C0040223
    RLS Diagnostic Criteria
    Descripción

    RLS Diagnostic Criteria

    Alias
    UMLS CUI-1
    C0035258
    UMLS CUI-2
    C0679228
    1)...a desire to move the limbs usually associated with parethesias or dysesthesias
    Descripción

    The International RLS Study Group Criteria* defines RLS patients as having: Answer to all four diagnostic criteria must be ’Yes’ for the patient to be diagnosed with RLS

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0596840
    UMLS CUI [2]
    C0030554
    UMLS CUI [3]
    C0392699
    UMLS CUI [4]
    C0035258
    2)...motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort)
    Descripción

    The International RLS Study Group Criteria* defines RLS patients as having:

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0700075
    3) ...symptoms worse or exclusively present at rest with at least partial or temporal relief by activity
    Descripción

    The International RLS Study Group Criteria* defines RLS patients as having:

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C0026606
    UMLS CUI [1,3]
    C0564405
    4) ...symptoms worse in the evening or night
    Descripción

    The International RLS Study Group Criteria* defines RLS patients as having:

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3176727
    UMLS CUI [1,2]
    C0035258
    Demography
    Descripción

    Demography

    Alias
    UMLS CUI-1
    C0011298
    Date of birth
    Descripción

    Date of birth

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Descripción

    Gender

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Descripción

    Race

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0034510
    Race, if other please specify
    Descripción

    Race

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0034510
    Vital signs
    Descripción

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0031809
    Height
    Descripción

    (without shoes)

    Tipo de datos

    float

    Unidades de medida
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Descripción

    (without shoes)

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Sitting blood pressure systolic
    Descripción

    Sitting blood pressure systolic

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0277814
    mmHg
    Sitting blood pressure diastolic
    Descripción

    Sitting blood pressure diastolic

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0277814
    mmHg
    Sitting heart rate
    Descripción

    Sitting heart rate

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0277814
    beats/min
    Electrocardiogram
    Descripción

    Electrocardiogram

    Alias
    UMLS CUI-1
    C0013798
    UMLS CUI-2
    C0430456
    Date of ECG
    Descripción

    Date of ECG

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0011008
    Were any clinically significant abnormalities detected?
    Descripción

    ECG abnormalities

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C0430456
    Laboratory Evaluation
    Descripción

    Laboratory Evaluation

    Alias
    UMLS CUI-1
    C0022885
    Date of blood sample
    Descripción

    Date of blood sample

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Were any clinically significant abnormalities detected?
    Descripción

    laboratory abnormalities

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1853129
    Urine Dipstick
    Descripción

    Urine Dipstick

    Alias
    UMLS CUI-1
    C0430370
    What was the result of the urine dipstick performed at this visit?
    Descripción

    result of the urine dipstick

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0430370
    UMLS CUI [1,2]
    C0456984
    Pregnancy dipstick
    Descripción

    Pregnancy dipstick

    Alias
    UMLS CUI-1
    C0430056
    UMLS CUI-2
    C0430370
    Is the patient a female of child-bearing potential?
    Descripción

    child-bearing potential

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1960468
    Pregnancy dipstick test result
    Descripción

    If ’Yes’, please perform a pregnancy dipstick test and record result below.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0427777
    UMLS CUI [1,2]
    C0430370
    Significant medical/surgical history and physical examination
    Descripción

    Significant medical/surgical history and physical examination

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0031809
    UMLS CUI-3
    C0012634
    Patient Initials
    Descripción

    Patient Initials

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2986440
    Is the patient suffering from or has he/she suffered from any significant medical or surgical condition?
    Descripción

    medical or surgical condition

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0012634
    UMLS CUI [2]
    C0009488
    Diagnosis
    Descripción

    If the patient is suffering from or has ever suffered from any significant medical or surgical condition please list below one diagnosis per line. (Please print clearly)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0009488
    Year of first diagnosis
    Descripción

    Year of first diagnosis

    Tipo de datos

    partialDate

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0439234
    Medical condition ongoing
    Descripción

    Medical condition ongoing

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0549178
    Prior and concomitant medication
    Descripción

    Prior and concomitant medication

    Alias
    UMLS CUI-1
    C2347852
    UMLS CUI-2
    C0013227
    UMLS CUI-3
    C2826257
    Has the patient taken any medication (excluding any pharmacotherapy medication for treatment of RLS) in the 3 months prior to study entry?
    Descripción

    If ‘Yes’, please record details below (Please print clearly)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0013227
    Drug Name (Trade Name Preferred)
    Descripción

    Drug Name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2360065
    Total Daily Dose
    Descripción

    Total Daily Dose

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0013227
    mg
    Medical Illness/Diagnosis
    Descripción

    Medical Illness/Diagnosis

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C3146298
    Start Date of medication (be as precise as possible)
    Descripción

    Start Date of medication

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    End Date of medication
    Descripción

    (or if Continuing mark box in upcoming question)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Medication continuing?
    Descripción

    Medication continuing?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
    RLS pharmacotherapy history
    Descripción

    RLS pharmacotherapy history

    Alias
    UMLS CUI-1
    C0013216
    UMLS CUI-2
    C0035258
    Has the patient taken any pharmacotherapy medication for treatment of RLS?
    Descripción

    If ‘Yes’, please record details below (Please print clearly)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0035258
    Drug Name (Trade Name Preferred)
    Descripción

    Drug Name

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2360065
    UMLS CUI [1,2]
    C0013216
    Start Date pharmacotherapy (be as precise as possible)
    Descripción

    Start Date pharmacotherapy

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0808070
    End Date pharmacotherapy
    Descripción

    (or if Continuing mark box in upcoming question)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0806020
    Medication continuing?
    Descripción

    Medication continuing?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0549178
    Did the patient respond to the treatment?
    Descripción

    Did the patient respond to the treatment?

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0521982
    UMLS CUI [1,2]
    C0013216
    UMLS CUI [1,3]
    C0035258
    Did the patient tolerate the treatment?
    Descripción

    Did the patient tolerate the treatment?

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013220
    UMLS CUI [1,2]
    C0013216
    UMLS CUI [1,3]
    C0035258
    Screening Inclusion/Exclusion Criteria
    Descripción

    Screening Inclusion/Exclusion Criteria

    Alias
    UMLS CUI-1
    C1710477
    UMLS CUI-2
    C0013893
    Patient is 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 their 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.
    Descripción

    Please complete the following inclusion criteria. If any of the above questions have been answered ’No’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0035258
    UMLS CUI [2]
    C1512693
    Patient is ≥ 18 years old and < 80 years of age.
    Descripción

    Please complete the following inclusion criteria. If any of the above questions have been answered ’No’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C1512693
    Patient has given written informed consent prior to any specific study procedures.
    Descripción

    Please complete the following inclusion criteria. If any of the above questions have been answered ’No’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2]
    C1512693
    Patient is suffering from RLS symptoms which require treatment during the daytime (daytime defined as 10.00 until 18.00).
    Descripción

    Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C1457887
    UMLS CUI [1,3]
    C0332169
    UMLS CUI [2]
    C0680251
    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).
    Descripción

    Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0236991
    UMLS CUI [2]
    C0680251
    Patient is suffering from a movement disorder (e.g. Parkinson’s Disease, dyskinesias or dystonias).
    Descripción

    Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0026650
    UMLS CUI [2]
    C0680251
    Patient has medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, etc.).
    Descripción

    Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C1280519
    UMLS CUI [2]
    C0680251
    Patient has exhibited intolerance to ropinirole or any other dopamine agonist.
    Descripción

    Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0178601
    UMLS CUI [2]
    C0680251
    Patient meets DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 6 months prior to Screening
    Descripción

    Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    UMLS CUI [2]
    C0680251
    Patient is a woman, of childbearing potential who 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). Please refer to document: CD-5.5, Informed Consent (Phase I-IV), section entitled ’Recommendations For Use of Women Of Childbearing Potential in Clinical Research Studies for SmithKline Beecham’
    Descripción

    Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0420837
    UMLS CUI [2]
    C0680251
    Patient is a woman who has a positive pregnancy test or is lactating.
    Descripción

    Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    UMLS CUI [2]
    C0680251
    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.).
    Descripción

    Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0009488
    UMLS CUI [2]
    C0680251
    Patient who, in the opinion of the Investigator, would be non-compliant with the visit schedule or other study procedures.
    Descripción

    Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    UMLS CUI [2]
    C0680251
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    Similar models

    Screening

    1 formularios
    1. StudyEvent: ODM
      1. Screening
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Screening
    C1710477 (UMLS CUI-1)
    C1516637 (UMLS CUI-2)
    C0013893 (UMLS CUI-3)
    Centre Number
    Item
    Centre Number
    integer
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    integer
    C1830427 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    age of onset restless legs syndrome
    Item
    How old was the patient at the onset of RLS?
    integer
    C0035258 (UMLS CUI [1,1])
    C0206132 (UMLS CUI [1,2])
    medication caused RLS
    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])
    C0085978 (UMLS CUI [1,3])
    medication caused RLS
    Item
    If ’Yes’ please specify medication(s)
    text
    C0013227 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    Item
    If female, did RLS symptoms develop during pregnancy?
    integer
    C0035258 (UMLS CUI [1,1])
    C0032961 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
    RLS symptoms develop during pregnancy
    Code List
    If female, did RLS symptoms develop during pregnancy?
    CL Item
    No (1)
    CL Item
    Yes (2)
    CL Item
    Not applicable (3)
    PLMS
    Item
    Has the patient ever had PLMS (Periodic Limb Movements during Sleep)?
    boolean
    C0596840 (UMLS CUI [1,1])
    C0037313 (UMLS CUI [1,2])
    C0035258 (UMLS CUI [2])
    age of onset of PLMS
    Item
    If 'Yes': How old was the patient at the onset of PLMS?
    integer
    C0206132 (UMLS CUI [1,1])
    C0596840 (UMLS CUI [1,2])
    C0037313 (UMLS CUI [1,3])
    C0035258 (UMLS CUI [2])
    alcohol consumption
    Item
    Does the patient drink alcohol?
    boolean
    C0001948 (UMLS CUI [1])
    alcohol consumptions
    Item
    If 'Yes": Units/week
    integer
    C0001948 (UMLS CUI [1,1])
    C0560579 (UMLS CUI [1,2])
    consumption of caffeine
    Item
    Does the patient drink caffeine (coffee, tea, caffeinated drinks)?
    boolean
    C0948365 (UMLS CUI [1])
    consumption of caffeine
    Item
    If 'Yes': Cups/day
    integer
    C0948365 (UMLS CUI [1])
    sleep disorder
    Item
    Does the patient have any sleep disorder as defined by DSM IV?
    boolean
    C0851578 (UMLS CUI [1,1])
    C0220952 (UMLS CUI [1,2])
    Item
    Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
    integer
    C1517194 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    first degree relative diagnosed with RLS
    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?
    CL Item
    No (1)
    CL Item
    Yes (2)
    CL Item
    Unknown (3)
    Item
    Are the patient’s current symptoms mainly present ...
    integer
    C1457887 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    time symptoms present
    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)
    Item Group
    RLS Diagnostic Criteria
    C0035258 (UMLS CUI-1)
    C0679228 (UMLS CUI-2)
    desire to move the limbs usually associated with parethesias or dysesthesias
    Item
    1)...a desire to move the limbs usually associated with parethesias or dysesthesias
    boolean
    C0596840 (UMLS CUI [1])
    C0030554 (UMLS CUI [2])
    C0392699 (UMLS CUI [3])
    C0035258 (UMLS CUI [4])
    motor restlessness
    Item
    2)...motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort)
    boolean
    C0700075 (UMLS CUI [1])
    symptoms worse at rest with at least partial or temporal relief by activity
    Item
    3) ...symptoms worse or exclusively present at rest with at least partial or temporal relief by activity
    boolean
    C0035258 (UMLS CUI [1,1])
    C0026606 (UMLS CUI [1,2])
    C0564405 (UMLS CUI [1,3])
    symptoms worse in the evening or night
    Item
    4) ...symptoms worse in the evening or night
    boolean
    C3176727 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    Item Group
    Demography
    C0011298 (UMLS CUI-1)
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    Male (M)
    CL Item
    Female (F)
    Item
    Race
    integer
    C0034510 (UMLS CUI [1])
    Race
    Code List
    Race
    CL Item
    White (1)
    CL Item
    Black (2)
    CL Item
    Oriental (3)
    CL Item
    Other (4)
    Race
    Item
    Race, if other please specify
    text
    C0034510 (UMLS CUI [1])
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    Height
    Item
    Height
    float
    C0005890 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Sitting blood pressure systolic
    Item
    Sitting blood pressure systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Sitting blood pressure diastolic
    Item
    Sitting blood pressure diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Sitting heart rate
    Item
    Sitting heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Item Group
    Electrocardiogram
    C0013798 (UMLS CUI-1)
    C0430456 (UMLS CUI-2)
    Date of ECG
    Item
    Date of ECG
    date
    C0430456 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    ECG abnormalities
    Item
    Were any clinically significant abnormalities detected?
    boolean
    C0522055 (UMLS CUI [1,1])
    C0430456 (UMLS CUI [1,2])
    Item Group
    Laboratory Evaluation
    C0022885 (UMLS CUI-1)
    Date of blood sample
    Item
    Date of blood sample
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    laboratory abnormalities
    Item
    Were any clinically significant abnormalities detected?
    boolean
    C1853129 (UMLS CUI [1])
    Item Group
    Urine Dipstick
    C0430370 (UMLS CUI-1)
    Item
    What was the result of the urine dipstick performed at this visit?
    integer
    C0430370 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    result of the urine dipstick
    Code List
    What was the result of the urine dipstick performed at this visit?
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    Item Group
    Pregnancy dipstick
    C0430056 (UMLS CUI-1)
    C0430370 (UMLS CUI-2)
    child-bearing potential
    Item
    Is the patient a female of child-bearing potential?
    boolean
    C1960468 (UMLS CUI [1])
    Item
    Pregnancy dipstick test result
    integer
    C0427777 (UMLS CUI [1,1])
    C0430370 (UMLS CUI [1,2])
    result of the urine dipstick
    Code List
    Pregnancy dipstick test result
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    Item Group
    Significant medical/surgical history and physical examination
    C0262926 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    C0012634 (UMLS CUI-3)
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    medical or surgical condition
    Item
    Is the patient suffering from or has he/she suffered from any significant medical or surgical condition?
    boolean
    C0012634 (UMLS CUI [1])
    C0009488 (UMLS CUI [2])
    Diagnosis
    Item
    Diagnosis
    text
    C0011900 (UMLS CUI [1,1])
    C0009488 (UMLS CUI [1,2])
    Year of first diagnosis
    Item
    Year of first diagnosis
    partialDate
    C0011900 (UMLS CUI [1,1])
    C0439234 (UMLS CUI [1,2])
    Item
    Medical condition ongoing
    integer
    C0012634 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Medical condition
    Code List
    Medical condition ongoing
    CL Item
    Past (1)
    CL Item
    Ongoing (2)
    CL Item
    Past + Ongoing (3)
    Item Group
    Prior and concomitant medication
    C2347852 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    C2826257 (UMLS CUI-3)
    medication
    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])
    Drug Name
    Item
    Drug Name (Trade Name Preferred)
    text
    C2360065 (UMLS CUI [1])
    Total Daily Dose
    Item
    Total Daily Dose
    float
    C2348070 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Medical Illness/Diagnosis
    Item
    Medical Illness/Diagnosis
    text
    C0011900 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C3146298 (UMLS CUI [1,3])
    Start Date of medication
    Item
    Start Date of medication (be as precise as possible)
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    End Date of medication
    Item
    End Date of medication
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Medication continuing?
    Item
    Medication continuing?
    boolean
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Item Group
    RLS pharmacotherapy history
    C0013216 (UMLS CUI-1)
    C0035258 (UMLS CUI-2)
    pharmacotherapy medication for treatment of RLS
    Item
    Has the patient taken any pharmacotherapy medication for treatment of RLS?
    boolean
    C0013216 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    Drug Name
    Item
    Drug Name (Trade Name Preferred)
    text
    C2360065 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    Start Date pharmacotherapy
    Item
    Start Date pharmacotherapy (be as precise as possible)
    date
    C0013216 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    End Date pharmacotherapy
    Item
    End Date pharmacotherapy
    date
    C0013216 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Medication continuing?
    Item
    Medication continuing?
    boolean
    C0013216 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Item
    Did the patient respond to the treatment?
    integer
    C0521982 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    C0035258 (UMLS CUI [1,3])
    first degree relative diagnosed with RLS
    Code List
    Did the patient respond to the treatment?
    CL Item
    No (1)
    CL Item
    Yes (2)
    CL Item
    Unknown (3)
    Item
    Did the patient tolerate the treatment?
    integer
    C0013220 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    C0035258 (UMLS CUI [1,3])
    first degree relative diagnosed with RLS
    Code List
    Did the patient tolerate the treatment?
    CL Item
    No (1)
    CL Item
    Yes (2)
    CL Item
    Unknown (3)
    Item Group
    Screening Inclusion/Exclusion Criteria
    C1710477 (UMLS CUI-1)
    C0013893 (UMLS CUI-2)
    diagnosed with RLS
    Item
    Patient is 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 their 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])
    C1512693 (UMLS CUI [2])
    age
    Item
    Patient is ≥ 18 years old and < 80 years of age.
    boolean
    C0001779 (UMLS CUI [1])
    C1512693 (UMLS CUI [2])
    informed consent
    Item
    Patient has given written informed consent prior to any specific study procedures.
    boolean
    C0021430 (UMLS CUI [1])
    C1512693 (UMLS CUI [2])
    RLS symptoms daytime
    Item
    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])
    C1457887 (UMLS CUI [1,2])
    C0332169 (UMLS CUI [1,3])
    C0680251 (UMLS CUI [2])
    primary sleep disorder
    Item
    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])
    C0680251 (UMLS CUI [2])
    movement disorder
    Item
    Patient is suffering from a movement disorder (e.g. Parkinson’s Disease, dyskinesias or dystonias).
    boolean
    C0026650 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
    medical conditions with symptoms which could affect assessments of efficacy
    Item
    Patient has medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, etc.).
    boolean
    C0009488 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C1280519 (UMLS CUI [1,3])
    C0680251 (UMLS CUI [2])
    intolerance to dopamine agonist
    Item
    Patient has exhibited intolerance to ropinirole or any other dopamine agonist.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0178601 (UMLS CUI [1,2])
    C0680251 (UMLS CUI [2])
    substance abuse
    Item
    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])
    C0680251 (UMLS CUI [2])
    contraception
    Item
    Patient is a woman, of childbearing potential who 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). Please refer to document: CD-5.5, Informed Consent (Phase I-IV), section entitled ’Recommendations For Use of Women Of Childbearing Potential in Clinical Research Studies for SmithKline Beecham’
    boolean
    C0420837 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
    positive pregnancy test or is lactating
    Item
    Patient is a woman who has a positive pregnancy test or is lactating.
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    C0680251 (UMLS CUI [2])
    medical conditions
    Item
    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 [1,1])
    C0009488 (UMLS CUI [1,2])
    C0680251 (UMLS CUI [2])
    non-compliant
    Item
    Patient who, in the opinion of the Investigator, would be non-compliant with the visit schedule or other study procedures.
    boolean
    C1321605 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
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