ID

38344

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 TMS (Transcranial Magnetic Stimulation Indicator, Transcranial Magnetic Stimulation) 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.

Link

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

Stichworte

Versionen (2)
  1. 04.10.19 04.10.19 -
  2. 11.10.19 11.10.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

11. Oktober 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

Englisch

TMS

1 Formulare  
  1. StudyEvent: ODM
    1. TMS
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.

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
Transcranial Magnetic Stimulation
Beschreibung

Transcranial Magnetic Stimulation

Alias
UMLS CUI-1
C0436548
Was TMS performed at this visit?
Beschreibung

If you tick no, please provide reason in the following item.

Datentyp

text

Alias
UMLS CUI [1,1]
C0436548
UMLS CUI [1,2]
C0884358
If TMS has been not performed, please provide reason
Beschreibung

TMS not done, Reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C0436548
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0566251
If there is an other reason for non TMS performance, please specify
Beschreibung

Other Reason, specification

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C0436548
UMLS CUI [1,3]
C1272696
UMLS CUI [1,4]
C2348235
If TMS has been performed, please note the actual date of assessment
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0436548
UMLS CUI [1,2]
C2985720
TMS - Location of stimulation point in reference to vertex
Beschreibung

TMS - Location of stimulation point in reference to vertex

Alias
UMLS CUI-1
C0436548
UMLS CUI-2
C0450429
Lateral distance
Beschreibung

Lateral distance

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C0230003
UMLS CUI [1,2]
C0205093
UMLS CUI [1,3]
C0012751
cm
Anterior/posterior distance result
Beschreibung

Anterior/posterior distance result

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C0230003
UMLS CUI [1,2]
C0205094
UMLS CUI [1,3]
C0012751
UMLS CUI [1,4]
C1274040
UMLS CUI [2,1]
C0230003
UMLS CUI [2,2]
C0205095
UMLS CUI [2,3]
C0012751
UMLS CUI [2,4]
C1274040
cm
Optimal stimulating point direction
Beschreibung

Optimal stimulating point direction

Datentyp

text

Alias
UMLS CUI [1,1]
C0449738
UMLS CUI [1,2]
C1292856
Motor threshold result
Beschreibung

Motor threshold result

Datentyp

float

Maßeinheiten
  • % of device output
Alias
UMLS CUI [1,1]
C0234130
UMLS CUI [1,2]
C0449864
UMLS CUI [1,3]
C1274040
% of device output
TMS - Recruitment Curve
Beschreibung

TMS - Recruitment Curve

Alias
UMLS CUI-1
C0436548
Stimulation Level
Beschreibung

Level 1: 100% of motor threshold Level 2: 110% of motor threshold Level 3: 120% of motor threshold Level 4: 130% of motor threshold Level 5: 140% of motor threshold

Datentyp

integer

Alias
UMLS CUI [1,1]
C0436548
UMLS CUI [1,2]
C1292856
UMLS CUI [1,3]
C2946261
Percent of maximum device output
Beschreibung

Percent of maximum device output

Datentyp

float

Maßeinheiten
  • % of device output
Alias
UMLS CUI [1,1]
C0436548
UMLS CUI [1,2]
C0699733
UMLS CUI [1,3]
C1709366
% of device output
Peak to peak MEP size
Beschreibung

Peak to peak MEP size

Datentyp

float

Maßeinheiten
  • millivolt
Alias
UMLS CUI [1,1]
C0282617
UMLS CUI [1,2]
C0456389
millivolt
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Ähnliche Modelle

TMS

1 Formulare
  1. StudyEvent: ODM
    1. TMS
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])
Visit Type
Code List
Visit Type
CL Item
Week 1 (1)
CL Item
Week 4 (2)
CL Item
Week 16 (3)
CL Item
Early withdrawal (4)
CL Item
Unscheduled (5)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Transcranial Magnetic Stimulation
C0436548 (UMLS CUI-1)
Item
Was TMS performed at this visit?
text
C0436548 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Performance of Transcranial Magnetic Stimulation
Code List
Was TMS performed at this visit?
CL Item
Yes (Y)
CL Item
No (N)
Item
If TMS has been not performed, please provide reason
integer
C0436548 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
No TMS, Reason
Code List
If TMS has been not performed, please provide reason
CL Item
Unable to obtain motor threshold (1)
CL Item
Equipment problem (2)
CL Item
Patient refused or could not tolerate TMS (3)
CL Item
Patient unavailable (4)
CL Item
Other (5)
Other Reason, specification
Item
If there is an other reason for non TMS performance, please specify
text
C3840932 (UMLS CUI [1,1])
C0436548 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Actual date of assessment
Item
If TMS has been performed, please note the actual date of assessment
date
C0436548 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
TMS - Location of stimulation point in reference to vertex
C0436548 (UMLS CUI-1)
C0450429 (UMLS CUI-2)
Lateral distance
Item
Lateral distance
float
C0230003 (UMLS CUI [1,1])
C0205093 (UMLS CUI [1,2])
C0012751 (UMLS CUI [1,3])
Anterior/posterior distance result
Item
Anterior/posterior distance result
float
C0230003 (UMLS CUI [1,1])
C0205094 (UMLS CUI [1,2])
C0012751 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C0230003 (UMLS CUI [2,1])
C0205095 (UMLS CUI [2,2])
C0012751 (UMLS CUI [2,3])
C1274040 (UMLS CUI [2,4])
Optimal stimulating point direction
Item
Optimal stimulating point direction
text
C0449738 (UMLS CUI [1,1])
C1292856 (UMLS CUI [1,2])
Motor threshold result
Item
Motor threshold result
float
C0234130 (UMLS CUI [1,1])
C0449864 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item Group
TMS - Recruitment Curve
C0436548 (UMLS CUI-1)
Item
Stimulation Level
integer
C0436548 (UMLS CUI [1,1])
C1292856 (UMLS CUI [1,2])
C2946261 (UMLS CUI [1,3])
Stimulation Level
Code List
Stimulation Level
CL Item
Level 1 (1)
CL Item
Level 2 (2)
CL Item
Level 3 (3)
CL Item
Level 4 (4)
CL Item
Level 5 (5)
Percent of maximum device output
Item
Percent of maximum device output
float
C0436548 (UMLS CUI [1,1])
C0699733 (UMLS CUI [1,2])
C1709366 (UMLS CUI [1,3])
Peak to peak MEP size
Item
Peak to peak MEP size
float
C0282617 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
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