ID
38344
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 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
Keywords
Versions (2)
- 10/4/19 10/4/19 -
- 10/11/19 10/11/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
October 11, 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
TMS
- StudyEvent: ODM
Description
Transcranial Magnetic Stimulation
Alias
- UMLS CUI-1
- C0436548
Description
If you tick no, please provide reason in the following item.
Data type
text
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C0884358
Description
TMS not done, Reason
Data type
integer
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [1,3]
- C0566251
Description
Other Reason, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C0436548
- UMLS CUI [1,3]
- C1272696
- UMLS CUI [1,4]
- C2348235
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C2985720
Description
TMS - Location of stimulation point in reference to vertex
Alias
- UMLS CUI-1
- C0436548
- UMLS CUI-2
- C0450429
Description
Lateral distance
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0230003
- UMLS CUI [1,2]
- C0205093
- UMLS CUI [1,3]
- C0012751
Description
Anterior/posterior distance result
Data type
float
Measurement units
- 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
Description
Optimal stimulating point direction
Data type
text
Alias
- UMLS CUI [1,1]
- C0449738
- UMLS CUI [1,2]
- C1292856
Description
Motor threshold result
Data type
float
Measurement units
- % of device output
Alias
- UMLS CUI [1,1]
- C0234130
- UMLS CUI [1,2]
- C0449864
- UMLS CUI [1,3]
- C1274040
Description
TMS - Recruitment Curve
Alias
- UMLS CUI-1
- C0436548
Description
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
Data type
integer
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C1292856
- UMLS CUI [1,3]
- C2946261
Description
Percent of maximum device output
Data type
float
Measurement units
- % of device output
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C0699733
- UMLS CUI [1,3]
- C1709366
Description
Peak to peak MEP size
Data type
float
Measurement units
- millivolt
Alias
- UMLS CUI [1,1]
- C0282617
- UMLS CUI [1,2]
- C0456389
Similar models
TMS
- StudyEvent: ODM
C0884358 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0436548 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C2985720 (UMLS CUI [1,2])
C0450429 (UMLS CUI-2)
C0205093 (UMLS CUI [1,2])
C0012751 (UMLS CUI [1,3])
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])
C1292856 (UMLS CUI [1,2])
C0449864 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1292856 (UMLS CUI [1,2])
C2946261 (UMLS CUI [1,3])
C0699733 (UMLS CUI [1,2])
C1709366 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])