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ID

38252

Beschreibung

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 Gait Velocity, the Berg Balance Scale and the Fugl-Meyer motor score Form. It has to be filled in for Week 1, Week 4, Week 16 and in case of early withdrawal. It also can be filled in unscheduled. The Gait Velocity and the Berg Balance Scale also has to be filled in for Week 8, Week 12.

Link

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

Stichworte

  1. 4/10/19 4/10/19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

4 de octubre de 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0

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    Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989

    Gait Velocity, Berg Balance Scale, Fugl-Meyer motor score

    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Beschreibung

    Subject number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Type
    Beschreibung

    Please tick for which visit you'll fill in this form. Note: Only the Gait Velocity and the berg balance scale have to be filled in for week 8 and week 12.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Date of Visit
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Gait Velocity
    Beschreibung

    Gait Velocity

    Alias
    UMLS CUI-1
    C0016928
    UMLS CUI-2
    C0436191
    Attempt Number
    Beschreibung

    Attempt Number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1516084
    UMLS CUI [1,2]
    C0449788
    Gait Velocity
    Beschreibung

    Fill in for each attempt.

    Datentyp

    float

    Maßeinheiten
    • Sec/10 Meters
    Alias
    UMLS CUI [1,1]
    C0016928
    UMLS CUI [1,2]
    C0436191
    Sec/10 Meters
    Berg Balance Scale
    Beschreibung

    Berg Balance Scale

    Alias
    UMLS CUI-1
    C1998325
    Berg Balance Scale, total score
    Beschreibung

    This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1998325
    UMLS CUI [1,2]
    C2964552
    Fugl-Meyer motor score
    Beschreibung

    Fugl-Meyer motor score

    Alias
    UMLS CUI-1
    C0234130
    UMLS CUI-2
    C0449820
    Fugl-Meyer motor score, subscore
    Beschreibung

    This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0234130
    UMLS CUI [1,2]
    C0449820

    Ähnliche Modelle

    Gait Velocity, Berg Balance Scale, Fugl-Meyer motor score

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item
    Visit Type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Code List
    Visit Type
    CL Item
    Week 1 (1)
    CL Item
    Week 4 (2)
    CL Item
    Week 8 (3)
    CL Item
    Week 12 (4)
    CL Item
    Week 16 (5)
    CL Item
    Early withdrawal (6)
    CL Item
    Unscheduled (7)
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Gait Velocity
    C0016928 (UMLS CUI-1)
    C0436191 (UMLS CUI-2)
    Item
    Attempt Number
    integer
    C1516084 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Code List
    Attempt Number
    CL Item
    First attempt (1)
    CL Item
    Second attempt (2)
    Gait Velocity
    Item
    Gait Velocity
    float
    C0016928 (UMLS CUI [1,1])
    C0436191 (UMLS CUI [1,2])
    Item Group
    Berg Balance Scale
    C1998325 (UMLS CUI-1)
    Berg Balance Scale, total score
    Item
    Berg Balance Scale, total score
    integer
    C1998325 (UMLS CUI [1,1])
    C2964552 (UMLS CUI [1,2])
    Item Group
    Fugl-Meyer motor score
    C0234130 (UMLS CUI-1)
    C0449820 (UMLS CUI-2)
    Fugl-Meyer motor score, subscore
    Item
    Fugl-Meyer motor score, subscore
    text
    C0234130 (UMLS CUI [1,1])
    C0449820 (UMLS CUI [1,2])

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