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35039

Beschreibung

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

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  1. 12.02.19 12.02.19 -
Rechteinhaber

GlaxoSmithKline

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12. Februar 2019

DOI

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    Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080

    Englisch

    Screening - Medications of special Interest; RLS Treatment Medications; Alcohol and Caffeine Intake; Current Tobacco Use; Restless Legs Syndrome History; International RLS Study Group Diagnostic Criteria; Subject's Food Intake; 12-Lead ECG

    1 Formulare  
    Administrative
    Beschreibung

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beschreibung

    Subject Identifier

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Medication of special Interest
    Beschreibung

    Medication of special Interest

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0543488
    Were any of the following medications taken by the subject prior to entering this study?
    Beschreibung

    If Yes, record details below.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0013227
    Medication of special Interest
    Beschreibung

    Medication of special Interest

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0543488
    Medication
    Beschreibung

    (Generic Name)

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0013227
    Was drug ever used?
    Beschreibung

    Was drug ever used?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0242510
    Medication Start Date
    Beschreibung

    Medication Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    Medication Stop Date
    Beschreibung

    Medication Stop Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Primary Reason Medication Started
    Beschreibung

    Primary Reason Medication Started

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1549995
    Prior RLS Treatment Medications
    Beschreibung

    Prior RLS Treatment Medications

    Alias
    UMLS CUI-1
    C0035258
    UMLS CUI-2
    C1514463
    Were any RLS treatment medications taken by the subject prior to entering this study?
    Beschreibung

    If Yes, record details below.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C1514463
    Prior RLS Treatment Medications
    Beschreibung

    Prior RLS Treatment Medications

    Alias
    UMLS CUI-1
    C0035258
    UMLS CUI-2
    C1514463
    Medication
    Beschreibung

    (Generic Name)

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0013227
    Was drug ever used?
    Beschreibung

    Was drug ever used?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0242510
    Medication Start Date
    Beschreibung

    Medication Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    Medication Stop Date
    Beschreibung

    Medication Stop Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Did the subject respond to treatment?
    Beschreibung

    Did the subject respond to treatment?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0521982
    Did the subject tolerate treatment?
    Beschreibung

    Did the subject tolerate treatment?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0013220
    Other RLS medication
    Beschreibung

    Other RLS medication

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0205394
    Alcohol intake
    Beschreibung

    Alcohol intake

    Alias
    UMLS CUI-1
    C0001948
    Does the subject consume alcohol?
    Beschreibung

    Does the subject consume alcohol?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001948
    If Yes, record the average number of units of alcohol consumed per week
    Beschreibung

    1 unit of alcohol in US = 1.5oz hard liquor, 1 beer, 4oz wine Round up to the nearest integer.

    Datentyp

    integer

    Maßeinheiten
    • units per week
    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0560579
    units per week
    Caffeine Intake
    Beschreibung

    Caffeine Intake

    Alias
    UMLS CUI-1
    C4062719
    Does the subject consume caffeine (coffee, tea, other caffeinated substances)?
    Beschreibung

    Does the subject consume caffeine (coffee, tea, other caffeinated substances)?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C4062719
    If Yes, record the average number of units of caffeine consumed per day
    Beschreibung

    8 fluid ounces coffee = 3 units (approximately 136mg caffeine) 8 fluid ounces tea = 2 units (approximately 64mg caffeine) 8 fluid ounces caffeinated soda = 1 unit (approximately 46mg caffeine) Round up to the nearest integer.

    Datentyp

    integer

    Maßeinheiten
    • units per day
    Alias
    UMLS CUI [1,1]
    C4062719
    UMLS CUI [1,2]
    C0439505
    units per day
    Current Tobacco Use
    Beschreibung

    Current Tobacco Use

    Alias
    UMLS CUI-1
    C0543414
    UMLS CUI-2
    C0521116
    Does the subject currently smoke/use tobacco?
    Beschreibung

    Does the subject currently smoke/use tobacco?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0521116
    If Yes, record average number of cigarettes smoked per day
    Beschreibung

    1 cigar = 7 cigarettes 1 gram (or 0.03 oz.) of tobacco = 1 cigarette Round up to the nearest integer

    Datentyp

    integer

    Maßeinheiten
    • cigarettes per day
    Alias
    UMLS CUI [1]
    C3694146
    cigarettes per day
    Restless Legs Syndrome History
    Beschreibung

    Restless Legs Syndrome History

    Alias
    UMLS CUI-1
    C0035258
    UMLS CUI-2
    C0262926
    1. What was the subject’s age at the onset of RLS?
    Beschreibung

    1. What was the subject’s age at the onset of RLS?

    Datentyp

    integer

    Maßeinheiten
    • years
    Alias
    UMLS CUI [1,1]
    C0001779
    UMLS CUI [1,2]
    C0277793
    UMLS CUI [1,3]
    C0035258
    years
    2. Did the subject start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
    Beschreibung

    2. Did the subject start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0205314
    UMLS CUI [1,3]
    C0277793
    UMLS CUI [1,4]
    C0035258
    UMLS CUI [1,5]
    C0085978
    If Yes, specify medication(s)
    Beschreibung

    If Yes, specify medication(s)

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C2348235
    3. If female, did RLS symptoms develop during pregnancy?
    Beschreibung

    3. If female, did RLS symptoms develop during pregnancy?

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C0032961
    4. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of RLS?
    Beschreibung

    4. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of RLS?

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C0026591
    UMLS CUI [2,1]
    C0035258
    UMLS CUI [2,2]
    C0015671
    UMLS CUI [3,1]
    C0035258
    UMLS CUI [3,2]
    C0337527
    UMLS CUI [4,1]
    C0035258
    UMLS CUI [4,2]
    C0337514
    UMLS CUI [5,1]
    C0035258
    UMLS CUI [5,2]
    C0037683
    UMLS CUI [6,1]
    C0035258
    UMLS CUI [6,2]
    C0011011
    5. Has the subject ever had PLMS (Periodic Limb Movements during Sleep)?
    Beschreibung

    5. Has the subject ever had PLMS (Periodic Limb Movements during Sleep)?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0596840
    UMLS CUI [1,2]
    C0037313
    UMLS CUI [1,3]
    C0035258
    If Yes, what was the subject’s age at the onset of PLMS?
    Beschreibung

    If Yes, what was the subject’s age at the onset of PLMS?

    Datentyp

    integer

    Maßeinheiten
    • years
    Alias
    UMLS CUI [1,1]
    C0596840
    UMLS CUI [1,2]
    C0037313
    UMLS CUI [1,3]
    C0035258
    UMLS CUI [1,4]
    C0001779
    years
    6. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of PLMS?
    Beschreibung

    6. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of PLMS?

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0596840
    UMLS CUI [1,2]
    C0037313
    UMLS CUI [1,3]
    C0035258
    UMLS CUI [1,4]
    C0026591
    UMLS CUI [2,1]
    C0596840
    UMLS CUI [2,2]
    C0037313
    UMLS CUI [2,3]
    C0035258
    UMLS CUI [2,4]
    C0015671
    UMLS CUI [3,1]
    C0596840
    UMLS CUI [3,2]
    C0037313
    UMLS CUI [3,3]
    C0035258
    UMLS CUI [3,4]
    C0337527
    UMLS CUI [4,1]
    C0596840
    UMLS CUI [4,2]
    C0037313
    UMLS CUI [4,3]
    C0035258
    UMLS CUI [4,4]
    C0337514
    UMLS CUI [5,1]
    C0596840
    UMLS CUI [5,2]
    C0037313
    UMLS CUI [5,3]
    C0035258
    UMLS CUI [5,4]
    C0037683
    UMLS CUI [6,1]
    C0596840
    UMLS CUI [6,2]
    C0037313
    UMLS CUI [6,3]
    C0035258
    UMLS CUI [6,4]
    C0011011
    7. Does the subject have any sleep disorder as defined by DSM IV other than qualifying disease state for this study?
    Beschreibung

    If Yes, record on the Medical Conditions page.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0851578
    UMLS CUI [1,2]
    C0220952
    8. When are the subject’s current RLS symptoms mainly present? ( ✔ only one box)
    Beschreibung

    8. When are the subject’s current RLS symptoms mainly present? ( ✔ only one box)

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C1457887
    UMLS CUI [1,3]
    C0521116
    UMLS CUI [1,4]
    C0040223
    9.Have any of the following parts of the subject’s body ever been affected by RLS symptoms?
    Beschreibung

    9. Have any of the following parts of the subject’s body ever been affected by RLS symptoms?

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0229962
    International Restless Leg Syndrome Study Group (IRLSSG) Diagnostic Criteria
    Beschreibung

    International Restless Leg Syndrome Study Group (IRLSSG) Diagnostic Criteria

    Alias
    UMLS CUI-1
    C0035258
    UMLS CUI-2
    C2348561
    UMLS CUI-3
    C0679228
    1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
    Beschreibung

    1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1863322
    UMLS CUI [2,1]
    C1140621
    UMLS CUI [2,2]
    C1527305
    UMLS CUI [2,3]
    C4062607
    2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
    Beschreibung

    2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1863322
    UMLS CUI [1,2]
    C0277814
    UMLS CUI [1,3]
    C0444334
    UMLS CUI [2,1]
    C1140621
    UMLS CUI [2,2]
    C1527305
    UMLS CUI [2,3]
    C4062607
    UMLS CUI [2,4]
    C0277814
    UMLS CUI [2,5]
    C0444334
    3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
    Beschreibung

    3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1863322
    UMLS CUI [1,2]
    C0026649
    UMLS CUI [2,1]
    C1140621
    UMLS CUI [2,2]
    C1527305
    UMLS CUI [2,3]
    C4062607
    UMLS CUI [2,4]
    C0564405
    UMLS CUI [2,5]
    C0026649
    4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.
    Beschreibung

    4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1863322
    UMLS CUI [1,2]
    C3176727
    UMLS CUI [2,1]
    C1140621
    UMLS CUI [2,2]
    C1527305
    UMLS CUI [2,3]
    C4062607
    UMLS CUI [2,4]
    C3176727
    Subject's Food Intake
    Beschreibung

    Subject's Food Intake

    Alias
    UMLS CUI-1
    C0518037
    Date and time of finishing last meal prior to the Screening Visit:
    Beschreibung

    Note: ECG measures should be taken two or more hours after a meal.

    Datentyp

    datetime

    Alias
    UMLS CUI [1]
    C0578574
    12-Lead ECG
    Beschreibung

    12-Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    Result of the ECG
    Beschreibung

    Check one Note: Perform ECGs in triplicate at least 2 hours after the subject’s last meal. Note: If abnormal, document abnormality in the Investigator Comment Log. Note: If any clinically significant abnormalities are noted, another ECG should be performed during the Screening and Washout Period. All clinically significant abnormalites must be resolved prior to Baseline Visit in order for the subject to be eligible for the study.

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0438154
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    Ähnliche Modelle

    Screening - Medications of special Interest; RLS Treatment Medications; Alcohol and Caffeine Intake; Current Tobacco Use; Restless Legs Syndrome History; International RLS Study Group Diagnostic Criteria; Subject's Food Intake; 12-Lead ECG

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Medication of special Interest
    C0013227 (UMLS CUI-1)
    C0543488 (UMLS CUI-2)
    Were any of the following medications taken by the subject prior to entering this study?
    Item
    Were any of the following medications taken by the subject prior to entering this study?
    boolean
    C0013227 (UMLS CUI [1])
    Item Group
    Medication of special Interest
    C0013227 (UMLS CUI-1)
    C0543488 (UMLS CUI-2)
    Item
    Medication
    integer
    C0013227 (UMLS CUI [1])
    Medication
    Code List
    Medication
    CL Item
    methysergide  (1)
    CL Item
    fenfluramine (2)
    CL Item
    dexfenfluramine (3)
    CL Item
    phentermine (4)
    Was drug ever used?
    Item
    Was drug ever used?
    boolean
    C0242510 (UMLS CUI [1])
    Medication Start Date
    Item
    Medication Start Date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Medication Stop Date
    Item
    Medication Stop Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Primary Reason Medication Started
    text
    C0013227 (UMLS CUI [1,1])
    C1549995 (UMLS CUI [1,2])
    Primary Reason Medication Started
    Code List
    Primary Reason Medication Started
    CL Item
    Migraine Headache Pain (12)
    CL Item
    Obesity (13)
    CL Item
    Other (OT)
    Item Group
    Prior RLS Treatment Medications
    C0035258 (UMLS CUI-1)
    C1514463 (UMLS CUI-2)
    Were any RLS treatment medications taken by the subject prior to entering this study?
    Item
    Were any RLS treatment medications taken by the subject prior to entering this study?
    boolean
    C0035258 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    Item Group
    Prior RLS Treatment Medications
    C0035258 (UMLS CUI-1)
    C1514463 (UMLS CUI-2)
    Item
    Medication
    integer
    C0013227 (UMLS CUI [1])
    Medication
    Code List
    Medication
    CL Item
    cabergoline (1)
    CL Item
    pergolide  (2)
    CL Item
    lisuride (3)
    CL Item
    bromocriptine (4)
    CL Item
    pramipexole (5)
    CL Item
    levodopa (6)
    CL Item
    ropinirole (7)
    Was drug ever used?
    Item
    Was drug ever used?
    boolean
    C0242510 (UMLS CUI [1])
    Medication Start Date
    Item
    Medication Start Date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Medication Stop Date
    Item
    Medication Stop Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Did the subject respond to treatment?
    Item
    Did the subject respond to treatment?
    boolean
    C0521982 (UMLS CUI [1])
    Did the subject tolerate treatment?
    Item
    Did the subject tolerate treatment?
    boolean
    C0013220 (UMLS CUI [1])
    Other RLS medication
    Item
    Other RLS medication
    text
    C0035258 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Item Group
    Alcohol intake
    C0001948 (UMLS CUI-1)
    Does the subject consume alcohol?
    Item
    Does the subject consume alcohol?
    boolean
    C0001948 (UMLS CUI [1])
    If Yes, record the average number of units of alcohol consumed per week
    Item
    If Yes, record the average number of units of alcohol consumed per week
    integer
    C0001948 (UMLS CUI [1,1])
    C0560579 (UMLS CUI [1,2])
    Item Group
    Caffeine Intake
    C4062719 (UMLS CUI-1)
    Does the subject consume caffeine (coffee, tea, other caffeinated substances)?
    Item
    Does the subject consume caffeine (coffee, tea, other caffeinated substances)?
    boolean
    C4062719 (UMLS CUI [1])
    If Yes, record the average number of units of caffeine consumed per day
    Item
    If Yes, record the average number of units of caffeine consumed per day
    integer
    C4062719 (UMLS CUI [1,1])
    C0439505 (UMLS CUI [1,2])
    Item Group
    Current Tobacco Use
    C0543414 (UMLS CUI-1)
    C0521116 (UMLS CUI-2)
    Does the subject currently smoke/use tobacco?
    Item
    Does the subject currently smoke/use tobacco?
    boolean
    C0543414 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    If Yes, record average number of cigarettes smoked per day
    Item
    If Yes, record average number of cigarettes smoked per day
    integer
    C3694146 (UMLS CUI [1])
    Item Group
    Restless Legs Syndrome History
    C0035258 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    1. What was the subject’s age at the onset of RLS?
    Item
    1. What was the subject’s age at the onset of RLS?
    integer
    C0001779 (UMLS CUI [1,1])
    C0277793 (UMLS CUI [1,2])
    C0035258 (UMLS CUI [1,3])
    2. Did the subject start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
    Item
    2. Did the subject start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
    boolean
    C0013227 (UMLS CUI [1,1])
    C0205314 (UMLS CUI [1,2])
    C0277793 (UMLS CUI [1,3])
    C0035258 (UMLS CUI [1,4])
    C0085978 (UMLS CUI [1,5])
    If Yes, specify medication(s)
    Item
    If Yes, specify medication(s)
    text
    C0013227 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item
    3. If female, did RLS symptoms develop during pregnancy?
    text
    C0035258 (UMLS CUI [1,1])
    C0032961 (UMLS CUI [1,2])
    3. If female, did RLS symptoms develop during pregnancy?
    Code List
    3. If female, did RLS symptoms develop during pregnancy?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not applicable (X)
    Item
    4. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of RLS?
    text
    C0035258 (UMLS CUI [1,1])
    C0026591 (UMLS CUI [1,2])
    C0035258 (UMLS CUI [2,1])
    C0015671 (UMLS CUI [2,2])
    C0035258 (UMLS CUI [3,1])
    C0337527 (UMLS CUI [3,2])
    C0035258 (UMLS CUI [4,1])
    C0337514 (UMLS CUI [4,2])
    C0035258 (UMLS CUI [5,1])
    C0037683 (UMLS CUI [5,2])
    C0035258 (UMLS CUI [6,1])
    C0011011 (UMLS CUI [6,2])
    4. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of RLS?
    Code List
    4. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of RLS?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (U)
    5. Has the subject ever had PLMS (Periodic Limb Movements during Sleep)?
    Item
    5. Has the subject ever had PLMS (Periodic Limb Movements during Sleep)?
    boolean
    C0596840 (UMLS CUI [1,1])
    C0037313 (UMLS CUI [1,2])
    C0035258 (UMLS CUI [1,3])
    If Yes, what was the subject’s age at the onset of PLMS?
    Item
    If Yes, what was the subject’s age at the onset of PLMS?
    integer
    C0596840 (UMLS CUI [1,1])
    C0037313 (UMLS CUI [1,2])
    C0035258 (UMLS CUI [1,3])
    C0001779 (UMLS CUI [1,4])
    Item
    6. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of PLMS?
    text
    C0596840 (UMLS CUI [1,1])
    C0037313 (UMLS CUI [1,2])
    C0035258 (UMLS CUI [1,3])
    C0026591 (UMLS CUI [1,4])
    C0596840 (UMLS CUI [2,1])
    C0037313 (UMLS CUI [2,2])
    C0035258 (UMLS CUI [2,3])
    C0015671 (UMLS CUI [2,4])
    C0596840 (UMLS CUI [3,1])
    C0037313 (UMLS CUI [3,2])
    C0035258 (UMLS CUI [3,3])
    C0337527 (UMLS CUI [3,4])
    C0596840 (UMLS CUI [4,1])
    C0037313 (UMLS CUI [4,2])
    C0035258 (UMLS CUI [4,3])
    C0337514 (UMLS CUI [4,4])
    C0596840 (UMLS CUI [5,1])
    C0037313 (UMLS CUI [5,2])
    C0035258 (UMLS CUI [5,3])
    C0037683 (UMLS CUI [5,4])
    C0596840 (UMLS CUI [6,1])
    C0037313 (UMLS CUI [6,2])
    C0035258 (UMLS CUI [6,3])
    C0011011 (UMLS CUI [6,4])
    6. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of PLMS?
    Code List
    6. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of PLMS?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (U)
    7. Does the subject have any sleep disorder as defined by DSM IV other than qualifying disease state for this study?
    Item
    7. Does the subject have any sleep disorder as defined by DSM IV other than qualifying disease state for this study?
    boolean
    C0851578 (UMLS CUI [1,1])
    C0220952 (UMLS CUI [1,2])
    Item
    8. When are the subject’s current RLS symptoms mainly present? ( ✔ only one box)
    integer
    C0035258 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    C0521116 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    8. When are the subject’s current RLS symptoms mainly present? ( ✔ only one box)
    Code List
    8. When are the subject’s current RLS symptoms mainly present? ( ✔ only one box)
    CL Item
    At nighttime only (8 PM - 6:59 AM) (1)
    CL Item
    In evening and nighttime (5:00 PM - 6:59 AM) (2)
    CL Item
    Daytime, evening and nighttime (symptoms during the day, evening and night) (3)
    Item
    9.Have any of the following parts of the subject’s body ever been affected by RLS symptoms?
    integer
    C0035258 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0229962 (UMLS CUI [1,3])
    9. Have any of the following parts of the subject’s body ever been affected by RLS symptoms?
    Code List
    9.Have any of the following parts of the subject’s body ever been affected by RLS symptoms?
    CL Item
    Right leg (1)
    CL Item
    Left leg (2)
    CL Item
    Right arm (3)
    CL Item
    Left arm (4)
    CL Item
    Trunk (5)
    CL Item
    Face or neck (6)
    Item Group
    International Restless Leg Syndrome Study Group (IRLSSG) Diagnostic Criteria
    C0035258 (UMLS CUI-1)
    C2348561 (UMLS CUI-2)
    C0679228 (UMLS CUI-3)
    1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
    Item
    1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
    boolean
    C1863322 (UMLS CUI [1])
    C1140621 (UMLS CUI [2,1])
    C1527305 (UMLS CUI [2,2])
    C4062607 (UMLS CUI [2,3])
    2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
    Item
    2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
    boolean
    C1863322 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    C0444334 (UMLS CUI [1,3])
    C1140621 (UMLS CUI [2,1])
    C1527305 (UMLS CUI [2,2])
    C4062607 (UMLS CUI [2,3])
    C0277814 (UMLS CUI [2,4])
    C0444334 (UMLS CUI [2,5])
    3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
    Item
    3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
    boolean
    C1863322 (UMLS CUI [1,1])
    C0026649 (UMLS CUI [1,2])
    C1140621 (UMLS CUI [2,1])
    C1527305 (UMLS CUI [2,2])
    C4062607 (UMLS CUI [2,3])
    C0564405 (UMLS CUI [2,4])
    C0026649 (UMLS CUI [2,5])
    4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.
    Item
    4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.
    boolean
    C1863322 (UMLS CUI [1,1])
    C3176727 (UMLS CUI [1,2])
    C1140621 (UMLS CUI [2,1])
    C1527305 (UMLS CUI [2,2])
    C4062607 (UMLS CUI [2,3])
    C3176727 (UMLS CUI [2,4])
    Item Group
    Subject's Food Intake
    C0518037 (UMLS CUI-1)
    Date and time of finishing last meal prior to the Screening Visit:
    Item
    Date and time of finishing last meal prior to the Screening Visit:
    datetime
    C0578574 (UMLS CUI [1])
    Item Group
    12-Lead ECG
    C0430456 (UMLS CUI-1)
    Item
    Result of the ECG
    integer
    C0438154 (UMLS CUI [1])
    Result of the ECG
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant (3)
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