ID

38255

Beschrijving

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 Geriatric Depression Scale (GDS), Montreal Cognitive Assessment (MOCA) Form. It has to be filled in for Week 1, Week 12 and in case of early withdrawal. It also can be filled in unscheduled.

Link

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

Trefwoorden

  1. 4/10/19 4/10/19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

4 de octubre de 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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

  1. StudyEvent: ODM
    1. GDS, MOCA
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Visit Type
Beschrijving

Please tick for which visit you'll fill in this form.

Datatype

integer

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

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
Geriatric Depression Scale
Beschrijving

Geriatric Depression Scale

Alias
UMLS CUI-1
C0451184
Geriatric Depression Scale, total score
Beschrijving

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

Datatype

integer

Alias
UMLS CUI [1,1]
C0451184
UMLS CUI [1,2]
C2964552
Montreal Cognitive Assessment
Beschrijving

Montreal Cognitive Assessment

Alias
UMLS CUI-1
C3496286
Montreal Cognitive Assessment, total score
Beschrijving

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

Datatype

integer

Alias
UMLS CUI [1,1]
C3496286
UMLS CUI [1,2]
C2964552

Similar models

GDS, MOCA

  1. StudyEvent: ODM
    1. GDS, MOCA
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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 12 (2)
CL Item
Early withdrawal (3)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Geriatric Depression Scale
C0451184 (UMLS CUI-1)
Geriatric Depression Scale, total score
Item
Geriatric Depression Scale, total score
integer
C0451184 (UMLS CUI [1,1])
C2964552 (UMLS CUI [1,2])
Item Group
Montreal Cognitive Assessment
C3496286 (UMLS CUI-1)
Montreal Cognitive Assessment, total score
Item
Montreal Cognitive Assessment, total score
integer
C3496286 (UMLS CUI [1,1])
C2964552 (UMLS CUI [1,2])

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