ID

38252

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 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

Keywords

  1. 10/4/19 10/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 4, 2019

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

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

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Type
Description

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.

Data type

integer

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

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Gait Velocity
Description

Gait Velocity

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

Attempt Number

Data type

integer

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

Fill in for each attempt.

Data type

float

Measurement units
  • Sec/10 Meters
Alias
UMLS CUI [1,1]
C0016928
UMLS CUI [1,2]
C0436191
Sec/10 Meters
Berg Balance Scale
Description

Berg Balance Scale

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

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

Data type

integer

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

Fugl-Meyer motor score

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

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

Data type

text

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

Similar models

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

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])
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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