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ID

44351

Description

Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the eligibility criteria. It has to be filled in at Day 1.

Link

https://clinicaltrials.gov/ct2/show/NCT00833989

Keywords

Versions (3)
  1. 10/4/19 10/4/19 -
  2. 10/24/19 10/24/19 - Sarah Riepenhausen
  3. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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    Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989

    English

    Eligibility Criteria

    1 forms  
    1. StudyEvent: ODM
      1. Eligibility Criteria
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date of visit
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Eligibility question
    Description

    Eligibility question

    Alias
    UMLS CUI-1
    C1516637
    Did the subject meet all the entry criteria?
    Description

    If you tick no, please select all boxes in the following items corresponding to violations of any inclusion/exclusion criteria

    Data type

    text

    Alias
    UMLS CUI [1]
    C1516637
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Have a confirmed diagnosis of stroke according to the World Health Organization definition
    Description

    WHO definition of stroke (1989): a rapid onset event of vascular origin reflecting a focal disturbance of cerebral function, excluding isolated impairments of higher function, and persisting longer than 24 hours

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0038454
    UMLS CUI [1,3]
    C0043237
    Stroke onset must be within the last 24-72 hours
    Description

    Time of stroke onset was defined as the time at which the subject/relative was first aware of the stroke deficit. For subjects who awoke with deficits, or who were found unconscious, the time of onset was defined as the time at which they were last known to be symptom free

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0521116
    UMLS CUI [1,2]
    C0038454
    UMLS CUI [1,3]
    C0449244
    Radiologically confirmed stroke, ischemic and supratentorial. The diameter of the ischemic lesion was >15 mm in any single direction or the volume was >4cc.
    Description

    Note: You have to tick either this item OR the following item ("Radiologically confirmed stroke, intracerebral hemorrhage")

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0043299
    UMLS CUI [1,2]
    C0948008
    UMLS CUI [1,3]
    C0441938
    UMLS CUI [2,1]
    C0948008
    UMLS CUI [2,2]
    C2700258
    UMLS CUI [3,1]
    C0948008
    UMLS CUI [3,2]
    C1301886
    Radiologically confirmed stroke, intracerebral hemorrhage that was supratentorial, deep (i.e., blood must not directly contact cerebral cortex) and with minimal or no intraventricular extension. The Intracerebral Hemorrhage (ICH) score must have been 0-2 and was calculated based on age, Glasgow Coma Scale score and the initial computed tomography (CT) or MRI findings for the index stroke. (Based on Protocol Amendment 4, subjects with ICH were not enrolled in Germany.)
    Description

    Note: You have to tick either this item OR the item before ("Radiologically confirmed stroke, ischemic and supratentorial")

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0043299
    UMLS CUI [1,2]
    C0038454
    UMLS CUI [1,3]
    C2937358
    UMLS CUI [1,4]
    C0441938
    UMLS CUI [1,5]
    C0205125
    UMLS CUI [1,6]
    C1298908
    UMLS CUI [1,7]
    C1517569
    UMLS CUI [1,8]
    C0231448
    UMLS CUI [2,1]
    C0043299
    UMLS CUI [2,2]
    C0038454
    UMLS CUI [2,3]
    C2937358
    UMLS CUI [2,4]
    C0441938
    UMLS CUI [2,5]
    C0205125
    UMLS CUI [2,6]
    C0547040
    UMLS CUI [2,7]
    C1517569
    UMLS CUI [2,8]
    C0231448
    UMLS CUI [3,1]
    C2937358
    UMLS CUI [3,2]
    C0449820
    Have a total NIHSS score of 3-21
    Description

    Based on Protocol Amendment 3, a total NIHSS score of 7-21 was used in Canada.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1697238
    Have an upper and/or lower limb deficit defined as: a. Score of 1-3 on the NIHSS Motor Arm question, and palpable and observable voluntary extension or flexion of the fingers. AND/OR b. Score of 1-3 on the NIHSS Motor Leg question
    Description

    Upper and/or lower limb deficit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1697238
    UMLS CUI [1,2]
    C0003794
    UMLS CUI [1,3]
    C2987487
    UMLS CUI [2,1]
    C1697238
    UMLS CUI [2,2]
    C0023220
    UMLS CUI [2,3]
    C2987487
    Aged 18-90, inclusive
    Description

    Based on Protocol Amendment 4, the upper age range for inclusion was 85 years of age in Germany.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy as indicated for the post stroke deficits
    Description

    Physical, occupational and speech rehabilitation therapy likely

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0949766
    UMLS CUI [1,2]
    C0750492
    UMLS CUI [2,1]
    C0037831
    UMLS CUI [2,2]
    C0750492
    UMLS CUI [3,1]
    C1318464
    UMLS CUI [3,2]
    C0750492
    Reasonable likelihood of receiving both doses of investigational product
    Description

    Both doses of investigational product

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0750492
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C1706086
    UMLS CUI [1,4]
    C0178602
    Was able to provide written and dated informed consent. Where the subject was unable to give consent, consent may have been obtained from the subject’s legally authorized representative in accordance with national legislation and local ethics committee guidelines. When able to do so, the subject was to be re-consented to continue in the study in the case where the consent was obtained from the legal representative in the first instance
    Description

    Informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0030705
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C1301860
    UMLS CUI [2,3]
    C0030701
    Male subjects and females of non-child-bearing potential are allowed to participate in this study
    Description

    Note: Females of child-bearing potential are also allowed to participate in this study provided they are using a contraceptive method with a failure rate of <1%

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    History of a previous symptomatic stroke within 3 months prior to study entry
    Description

    Previous symptomic stroke

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332185
    UMLS CUI [1,2]
    C0559159
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C2348568
    Presence of significant disability prior to the current stroke. Significant disability is defined as having a pre-stroke Rankin score of >2
    Description

    Significant disability prior to stroke, rankin score

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0231170
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C0038454
    UMLS CUI [1,4]
    C0451405
    Presence of depression that is active and not adequately controlled such that it interferred with major activities of daily living immediately prior to the current stroke
    Description

    Active and uncontrolled depression

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205177
    UMLS CUI [1,2]
    C0011581
    UMLS CUI [1,3]
    C0205318
    Subjects who are not alert or are unresponsive
    Description

    defined by a score of 2 or 3 on the NIHSS Level of Consciousness question

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0241526
    UMLS CUI [1,2]
    C1697238
    UMLS CUI [2,1]
    C3665546
    UMLS CUI [2,2]
    C1298908
    UMLS CUI [2,3]
    C1697238
    Presence of significant aphasia as likely to confound or interfere with completion of the study assessments
    Description

    aphasia affecting assessments

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003537
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0431080
    Presence of peripheral neuropathy, including diabetic neuropathy, which was clinically active and symptomatic at time of screening.
    Description

    symptomatic Peripheral neuropathy, diabetic neuropathy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0231220
    UMLS CUI [1,2]
    C0031117
    UMLS CUI [2]
    C0011882
    Presence of neurological or psychiatric disease, such as dementia or mild cognitive impairment, prior to study entry that is likely to confound clinical evaluations
    Description

    Neurological or psychiatric disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027765
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0431080
    UMLS CUI [1,4]
    C0332152
    UMLS CUI [1,5]
    C0008976
    UMLS CUI [1,6]
    C0679823
    UMLS CUI [2,1]
    C0004936
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0431080
    UMLS CUI [2,4]
    C0332152
    UMLS CUI [2,5]
    C0008976
    UMLS CUI [2,6]
    C0679823
    UMLS CUI [3]
    C0497327
    UMLS CUI [4]
    C1270972
    Presence of a demyelinating disease, such as multiple sclerosis
    Description

    Demyelinating disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011303
    UMLS CUI [2]
    C0026769
    Evidence of other chronic co-morbid conditions or unstable acute systemic illnesses which, in the opinion of the investigator, could have shortened the subject's survival or limited his/her ability to complete the study
    Description

    Other chronic co-morbid conditions or unstable acute systemic illnesses affecting study completion/life expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0008679
    UMLS CUI [1,3]
    C0392760
    UMLS CUI [1,4]
    C2826674
    UMLS CUI [2,1]
    C0205394
    UMLS CUI [2,2]
    C0008679
    UMLS CUI [2,3]
    C0392760
    UMLS CUI [2,4]
    C0023671
    UMLS CUI [3,1]
    C0443343
    UMLS CUI [3,2]
    C0205178
    UMLS CUI [3,3]
    C0442893
    UMLS CUI [3,4]
    C0392760
    UMLS CUI [3,5]
    C2826674
    UMLS CUI [4,1]
    C0443343
    UMLS CUI [4,2]
    C0205178
    UMLS CUI [4,3]
    C0442893
    UMLS CUI [4,4]
    C0392760
    UMLS CUI [4,5]
    C0023671
    History of sensitivity to heparin or heparin-induced thrombocytopenia
    Description

    Sensitivity to heparin or heparin-induced thrombocytopenia

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0020517
    UMLS CUI [1,3]
    C0019134
    UMLS CUI [2,1]
    C0262926
    UMLS CUI [2,2]
    C0272285
    Presence of QTc > 500 msec; or uncorrected QT >600msec (machine or manual over-read) on baseline ECG. If bundle branch block was present, then QTc must not have been > 530 msec.
    Description

    QTcB, uncorrected QT, bundle branch block

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1882512
    UMLS CUI [2]
    C1287082
    UMLS CUI [3]
    C0006384
    Contraindication to TMS
    Description

    Contraindication such as: -had metal present, such as hardware or plate on the scalp in the area to which TMS was applied, implanted cardiac pacemaker, implanted prosthetic heart valve, medication pump or line, metallic implant or clip in the head/neck, electrical, mechanical or magnetic implants, neuro-stimulation device, or orthodontic work involving ferromagnetic materials -occupation or activity that could cause accidental lodging of ferromagnetic materials or embedded metal fragments in the head. Subjects could be cleared by a head computed tomography scan. -concomitant use of drugs that substantially lower seizure threshold (e.g., tricyclic antidepressants and neuroleptics) -known history of seizures or epilepsy -brain tumour, recent brain injury (within 5 years) associated with definite loss of consciousness, or any history of brain surgery -other contraindications per local hospital practice

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0436548
    UMLS CUI [2,1]
    C0025552
    UMLS CUI [2,2]
    C0460148
    UMLS CUI [2,3]
    C0150312
    UMLS CUI [3,1]
    C0028811
    UMLS CUI [3,2]
    C0016542
    UMLS CUI [3,3]
    C3178787
    UMLS CUI [3,4]
    C1268086
    UMLS CUI [4,1]
    C0441655
    UMLS CUI [4,2]
    C0016542
    UMLS CUI [4,3]
    C3178787
    UMLS CUI [4,4]
    C1268086
    UMLS CUI [5,1]
    C2347852
    UMLS CUI [5,2]
    C0234976
    UMLS CUI [6,1]
    C0262926
    UMLS CUI [6,2]
    C0036572
    UMLS CUI [7,1]
    C0262926
    UMLS CUI [7,2]
    C0014544
    UMLS CUI [8]
    C0006118
    UMLS CUI [9,1]
    C0332665
    UMLS CUI [9,2]
    C0270611
    Contraindication to MRI
    Description

    Contraindication such as: -have metal present, such as implanted cardiac pacemaker, implanted prosthetic heart valve, medication pump or line, metallic implant or clip in the head/neck, electrical, mechanical or magnetic implants, neuro-stimulation device, or orthodontic work involving ferromagnetic materials, permanent tattooed metallic eye-liner -occupation or activity that may cause accidental lodging of ferromagnetic materials or embedded metal fragments in the head. Subjects can be cleared by a head computed tomography scan -claustrophobia -other contraindications per local hospital practice

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0024485
    UMLS CUI [2,1]
    C0025552
    UMLS CUI [2,2]
    C0460148
    UMLS CUI [2,3]
    C0150312
    UMLS CUI [3,1]
    C0028811
    UMLS CUI [3,2]
    C0016542
    UMLS CUI [3,3]
    C3178787
    UMLS CUI [3,4]
    C1268086
    UMLS CUI [4,1]
    C0441655
    UMLS CUI [4,2]
    C0016542
    UMLS CUI [4,3]
    C3178787
    UMLS CUI [4,4]
    C1268086
    UMLS CUI [5]
    C0008909
    Participation in any investigational rehabilitation paradigm targeting stroke recovery during the duration of this study
    Description

    Participation in other clinical trial

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C1517586
    UMLS CUI [1,3]
    C2348568
    UMLS CUI [1,4]
    C0347984
    UMLS CUI [1,5]
    C2926735
    UMLS CUI [1,6]
    C0008976
    The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
    Description

    Participation in other clinical trial, investigational product

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0332185
    UMLS CUI [1,3]
    C2348568
    UMLS CUI [1,4]
    C0304229
    History of sensitivity to GSK249320, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicated their participation
    Description

    Sensitivity to investigational product or components thereof

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C1705248
    UMLS CUI [2,3]
    C0304229
    UMLS CUI [3,1]
    C0262926
    UMLS CUI [3,2]
    C0013227
    UMLS CUI [4,1]
    C0205394
    UMLS CUI [4,2]
    C0020517
    Pregnant females as determined by positive urine human chorionic gonadotropin (hCG) test at screening or prior to dosing
    Description

    Pregnant females, Urine hcg test

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2,1]
    C1141639
    UMLS CUI [2,2]
    C1446409
    UMLS CUI [2,3]
    C0430056
    Lactating females
    Description

    Lactating females

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006147
    Subjects considered unwilling or unable to comply with the procedures and study visit schedule outlined in the protocol
    Description

    Protocol compliance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C1299582
    UMLS CUI [2,1]
    C0525058
    UMLS CUI [2,2]
    C0558080
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    Eligibility Criteria

    1 forms
    1. StudyEvent: ODM
      1. Eligibility Criteria
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Eligibility question
    C1516637 (UMLS CUI-1)
    Item
    Did the subject meet all the entry criteria?
    text
    C1516637 (UMLS CUI [1])
    Entry criteria
    Code List
    Did the subject meet all the entry criteria?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Stroke
    Item
    Have a confirmed diagnosis of stroke according to the World Health Organization definition
    boolean
    C0750484 (UMLS CUI [1,1])
    C0038454 (UMLS CUI [1,2])
    C0043237 (UMLS CUI [1,3])
    Onset of stroke
    Item
    Stroke onset must be within the last 24-72 hours
    boolean
    C0521116 (UMLS CUI [1,1])
    C0038454 (UMLS CUI [1,2])
    C0449244 (UMLS CUI [1,3])
    Radiologically confirmed stroke, ischemic and supratentorial, diameter or volume
    Item
    Radiologically confirmed stroke, ischemic and supratentorial. The diameter of the ischemic lesion was >15 mm in any single direction or the volume was >4cc.
    boolean
    C0043299 (UMLS CUI [1,1])
    C0948008 (UMLS CUI [1,2])
    C0441938 (UMLS CUI [1,3])
    C0948008 (UMLS CUI [2,1])
    C2700258 (UMLS CUI [2,2])
    C0948008 (UMLS CUI [3,1])
    C1301886 (UMLS CUI [3,2])
    Radiologically confirmed stroke, intracerebral hemorrhage, intracerebral hemorrhage score
    Item
    Radiologically confirmed stroke, intracerebral hemorrhage that was supratentorial, deep (i.e., blood must not directly contact cerebral cortex) and with minimal or no intraventricular extension. The Intracerebral Hemorrhage (ICH) score must have been 0-2 and was calculated based on age, Glasgow Coma Scale score and the initial computed tomography (CT) or MRI findings for the index stroke. (Based on Protocol Amendment 4, subjects with ICH were not enrolled in Germany.)
    boolean
    C0043299 (UMLS CUI [1,1])
    C0038454 (UMLS CUI [1,2])
    C2937358 (UMLS CUI [1,3])
    C0441938 (UMLS CUI [1,4])
    C0205125 (UMLS CUI [1,5])
    C1298908 (UMLS CUI [1,6])
    C1517569 (UMLS CUI [1,7])
    C0231448 (UMLS CUI [1,8])
    C0043299 (UMLS CUI [2,1])
    C0038454 (UMLS CUI [2,2])
    C2937358 (UMLS CUI [2,3])
    C0441938 (UMLS CUI [2,4])
    C0205125 (UMLS CUI [2,5])
    C0547040 (UMLS CUI [2,6])
    C1517569 (UMLS CUI [2,7])
    C0231448 (UMLS CUI [2,8])
    C2937358 (UMLS CUI [3,1])
    C0449820 (UMLS CUI [3,2])
    NIHSS score
    Item
    Have a total NIHSS score of 3-21
    boolean
    C1697238 (UMLS CUI [1])
    Upper and/or lower limb deficit
    Item
    Have an upper and/or lower limb deficit defined as: a. Score of 1-3 on the NIHSS Motor Arm question, and palpable and observable voluntary extension or flexion of the fingers. AND/OR b. Score of 1-3 on the NIHSS Motor Leg question
    boolean
    C1697238 (UMLS CUI [1,1])
    C0003794 (UMLS CUI [1,2])
    C2987487 (UMLS CUI [1,3])
    C1697238 (UMLS CUI [2,1])
    C0023220 (UMLS CUI [2,2])
    C2987487 (UMLS CUI [2,3])
    Age
    Item
    Aged 18-90, inclusive
    boolean
    C0001779 (UMLS CUI [1])
    Physical, occupational and speech rehabilitation therapy likely
    Item
    Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy as indicated for the post stroke deficits
    boolean
    C0949766 (UMLS CUI [1,1])
    C0750492 (UMLS CUI [1,2])
    C0037831 (UMLS CUI [2,1])
    C0750492 (UMLS CUI [2,2])
    C1318464 (UMLS CUI [3,1])
    C0750492 (UMLS CUI [3,2])
    Both doses of investigational product
    Item
    Reasonable likelihood of receiving both doses of investigational product
    boolean
    C0750492 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C1706086 (UMLS CUI [1,3])
    C0178602 (UMLS CUI [1,4])
    Informed consent
    Item
    Was able to provide written and dated informed consent. Where the subject was unable to give consent, consent may have been obtained from the subject’s legally authorized representative in accordance with national legislation and local ethics committee guidelines. When able to do so, the subject was to be re-consented to continue in the study in the case where the consent was obtained from the legal representative in the first instance
    boolean
    C0021430 (UMLS CUI [1,1])
    C0030705 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2,1])
    C1301860 (UMLS CUI [2,2])
    C0030701 (UMLS CUI [2,3])
    Sex
    Item
    Male subjects and females of non-child-bearing potential are allowed to participate in this study
    boolean
    C0079399 (UMLS CUI [1])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Previous symptomic stroke
    Item
    History of a previous symptomatic stroke within 3 months prior to study entry
    boolean
    C0332185 (UMLS CUI [1,1])
    C0559159 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C2348568 (UMLS CUI [1,4])
    Significant disability prior to stroke, rankin score
    Item
    Presence of significant disability prior to the current stroke. Significant disability is defined as having a pre-stroke Rankin score of >2
    boolean
    C0231170 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0038454 (UMLS CUI [1,3])
    C0451405 (UMLS CUI [1,4])
    Active and uncontrolled depression
    Item
    Presence of depression that is active and not adequately controlled such that it interferred with major activities of daily living immediately prior to the current stroke
    boolean
    C0205177 (UMLS CUI [1,1])
    C0011581 (UMLS CUI [1,2])
    C0205318 (UMLS CUI [1,3])
    Unresponsive, not alert
    Item
    Subjects who are not alert or are unresponsive
    boolean
    C0241526 (UMLS CUI [1,1])
    C1697238 (UMLS CUI [1,2])
    C3665546 (UMLS CUI [2,1])
    C1298908 (UMLS CUI [2,2])
    C1697238 (UMLS CUI [2,3])
    aphasia affecting assessments
    Item
    Presence of significant aphasia as likely to confound or interfere with completion of the study assessments
    boolean
    C0003537 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0431080 (UMLS CUI [1,3])
    symptomatic Peripheral neuropathy, diabetic neuropathy
    Item
    Presence of peripheral neuropathy, including diabetic neuropathy, which was clinically active and symptomatic at time of screening.
    boolean
    C0231220 (UMLS CUI [1,1])
    C0031117 (UMLS CUI [1,2])
    C0011882 (UMLS CUI [2])
    Neurological or psychiatric disease
    Item
    Presence of neurological or psychiatric disease, such as dementia or mild cognitive impairment, prior to study entry that is likely to confound clinical evaluations
    boolean
    C0027765 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0431080 (UMLS CUI [1,3])
    C0332152 (UMLS CUI [1,4])
    C0008976 (UMLS CUI [1,5])
    C0679823 (UMLS CUI [1,6])
    C0004936 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0431080 (UMLS CUI [2,3])
    C0332152 (UMLS CUI [2,4])
    C0008976 (UMLS CUI [2,5])
    C0679823 (UMLS CUI [2,6])
    C0497327 (UMLS CUI [3])
    C1270972 (UMLS CUI [4])
    Demyelinating disease
    Item
    Presence of a demyelinating disease, such as multiple sclerosis
    boolean
    C0011303 (UMLS CUI [1])
    C0026769 (UMLS CUI [2])
    Other chronic co-morbid conditions or unstable acute systemic illnesses affecting study completion/life expectancy
    Item
    Evidence of other chronic co-morbid conditions or unstable acute systemic illnesses which, in the opinion of the investigator, could have shortened the subject's survival or limited his/her ability to complete the study
    boolean
    C0205394 (UMLS CUI [1,1])
    C0008679 (UMLS CUI [1,2])
    C0392760 (UMLS CUI [1,3])
    C2826674 (UMLS CUI [1,4])
    C0205394 (UMLS CUI [2,1])
    C0008679 (UMLS CUI [2,2])
    C0392760 (UMLS CUI [2,3])
    C0023671 (UMLS CUI [2,4])
    C0443343 (UMLS CUI [3,1])
    C0205178 (UMLS CUI [3,2])
    C0442893 (UMLS CUI [3,3])
    C0392760 (UMLS CUI [3,4])
    C2826674 (UMLS CUI [3,5])
    C0443343 (UMLS CUI [4,1])
    C0205178 (UMLS CUI [4,2])
    C0442893 (UMLS CUI [4,3])
    C0392760 (UMLS CUI [4,4])
    C0023671 (UMLS CUI [4,5])
    Sensitivity to heparin or heparin-induced thrombocytopenia
    Item
    History of sensitivity to heparin or heparin-induced thrombocytopenia
    boolean
    C0262926 (UMLS CUI [1,1])
    C0020517 (UMLS CUI [1,2])
    C0019134 (UMLS CUI [1,3])
    C0262926 (UMLS CUI [2,1])
    C0272285 (UMLS CUI [2,2])
    QTcB, uncorrected QT, bundle branch block
    Item
    Presence of QTc > 500 msec; or uncorrected QT >600msec (machine or manual over-read) on baseline ECG. If bundle branch block was present, then QTc must not have been > 530 msec.
    boolean
    C1882512 (UMLS CUI [1])
    C1287082 (UMLS CUI [2])
    C0006384 (UMLS CUI [3])
    Contraindication to TMS
    Item
    Contraindication to TMS
    boolean
    C1301624 (UMLS CUI [1,1])
    C0436548 (UMLS CUI [1,2])
    C0025552 (UMLS CUI [2,1])
    C0460148 (UMLS CUI [2,2])
    C0150312 (UMLS CUI [2,3])
    C0028811 (UMLS CUI [3,1])
    C0016542 (UMLS CUI [3,2])
    C3178787 (UMLS CUI [3,3])
    C1268086 (UMLS CUI [3,4])
    C0441655 (UMLS CUI [4,1])
    C0016542 (UMLS CUI [4,2])
    C3178787 (UMLS CUI [4,3])
    C1268086 (UMLS CUI [4,4])
    C2347852 (UMLS CUI [5,1])
    C0234976 (UMLS CUI [5,2])
    C0262926 (UMLS CUI [6,1])
    C0036572 (UMLS CUI [6,2])
    C0262926 (UMLS CUI [7,1])
    C0014544 (UMLS CUI [7,2])
    C0006118 (UMLS CUI [8])
    C0332665 (UMLS CUI [9,1])
    C0270611 (UMLS CUI [9,2])
    Contraindication to MRI
    Item
    Contraindication to MRI
    boolean
    C1301624 (UMLS CUI [1,1])
    C0024485 (UMLS CUI [1,2])
    C0025552 (UMLS CUI [2,1])
    C0460148 (UMLS CUI [2,2])
    C0150312 (UMLS CUI [2,3])
    C0028811 (UMLS CUI [3,1])
    C0016542 (UMLS CUI [3,2])
    C3178787 (UMLS CUI [3,3])
    C1268086 (UMLS CUI [3,4])
    C0441655 (UMLS CUI [4,1])
    C0016542 (UMLS CUI [4,2])
    C3178787 (UMLS CUI [4,3])
    C1268086 (UMLS CUI [4,4])
    C0008909 (UMLS CUI [5])
    Participation in other clinical trial
    Item
    Participation in any investigational rehabilitation paradigm targeting stroke recovery during the duration of this study
    boolean
    C0205394 (UMLS CUI [1,1])
    C1517586 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    C0347984 (UMLS CUI [1,4])
    C2926735 (UMLS CUI [1,5])
    C0008976 (UMLS CUI [1,6])
    Participation in other clinical trial, investigational product
    Item
    The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
    boolean
    C0205394 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [1,4])
    Sensitivity to investigational product or components thereof
    Item
    History of sensitivity to GSK249320, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicated their participation
    boolean
    C0020517 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C1705248 (UMLS CUI [2,2])
    C0304229 (UMLS CUI [2,3])
    C0262926 (UMLS CUI [3,1])
    C0013227 (UMLS CUI [3,2])
    C0205394 (UMLS CUI [4,1])
    C0020517 (UMLS CUI [4,2])
    Pregnant females, Urine hcg test
    Item
    Pregnant females as determined by positive urine human chorionic gonadotropin (hCG) test at screening or prior to dosing
    boolean
    C0032961 (UMLS CUI [1])
    C1141639 (UMLS CUI [2,1])
    C1446409 (UMLS CUI [2,2])
    C0430056 (UMLS CUI [2,3])
    Lactating females
    Item
    Lactating females
    boolean
    C0006147 (UMLS CUI [1])
    Protocol compliance
    Item
    Subjects considered unwilling or unable to comply with the procedures and study visit schedule outlined in the protocol
    boolean
    C0525058 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [2,1])
    C0558080 (UMLS CUI [2,2])
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