ID
38344
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00833989
Nyckelord
Versioner (2)
- 2019-10-04 2019-10-04 -
- 2019-10-11 2019-10-11 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
11 oktober 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989
TMS
- StudyEvent: ODM
Beskrivning
Transcranial Magnetic Stimulation
Alias
- UMLS CUI-1
- C0436548
Beskrivning
If you tick no, please provide reason in the following item.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C0884358
Beskrivning
TMS not done, Reason
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [1,3]
- C0566251
Beskrivning
Other Reason, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C0436548
- UMLS CUI [1,3]
- C1272696
- UMLS CUI [1,4]
- C2348235
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C2985720
Beskrivning
TMS - Location of stimulation point in reference to vertex
Alias
- UMLS CUI-1
- C0436548
- UMLS CUI-2
- C0450429
Beskrivning
Lateral distance
Datatyp
float
Måttenheter
- cm
Alias
- UMLS CUI [1,1]
- C0230003
- UMLS CUI [1,2]
- C0205093
- UMLS CUI [1,3]
- C0012751
Beskrivning
Anterior/posterior distance result
Datatyp
float
Måttenheter
- 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
Beskrivning
Optimal stimulating point direction
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0449738
- UMLS CUI [1,2]
- C1292856
Beskrivning
Motor threshold result
Datatyp
float
Måttenheter
- % of device output
Alias
- UMLS CUI [1,1]
- C0234130
- UMLS CUI [1,2]
- C0449864
- UMLS CUI [1,3]
- C1274040
Beskrivning
TMS - Recruitment Curve
Alias
- UMLS CUI-1
- C0436548
Beskrivning
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
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C1292856
- UMLS CUI [1,3]
- C2946261
Beskrivning
Percent of maximum device output
Datatyp
float
Måttenheter
- % of device output
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C0699733
- UMLS CUI [1,3]
- C1709366
Beskrivning
Peak to peak MEP size
Datatyp
float
Måttenheter
- 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])