ID
38344
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 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
Trefwoorden
Versies (2)
- 04-10-19 04-10-19 -
- 11-10-19 11-10-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
11 oktober 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989
TMS
- StudyEvent: ODM
Beschrijving
Transcranial Magnetic Stimulation
Alias
- UMLS CUI-1
- C0436548
Beschrijving
If you tick no, please provide reason in the following item.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C0884358
Beschrijving
TMS not done, Reason
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [1,3]
- C0566251
Beschrijving
Other Reason, specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C0436548
- UMLS CUI [1,3]
- C1272696
- UMLS CUI [1,4]
- C2348235
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C2985720
Beschrijving
TMS - Location of stimulation point in reference to vertex
Alias
- UMLS CUI-1
- C0436548
- UMLS CUI-2
- C0450429
Beschrijving
Lateral distance
Datatype
float
Maateenheden
- cm
Alias
- UMLS CUI [1,1]
- C0230003
- UMLS CUI [1,2]
- C0205093
- UMLS CUI [1,3]
- C0012751
Beschrijving
Anterior/posterior distance result
Datatype
float
Maateenheden
- 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
Beschrijving
Optimal stimulating point direction
Datatype
text
Alias
- UMLS CUI [1,1]
- C0449738
- UMLS CUI [1,2]
- C1292856
Beschrijving
Motor threshold result
Datatype
float
Maateenheden
- % of device output
Alias
- UMLS CUI [1,1]
- C0234130
- UMLS CUI [1,2]
- C0449864
- UMLS CUI [1,3]
- C1274040
Beschrijving
TMS - Recruitment Curve
Alias
- UMLS CUI-1
- C0436548
Beschrijving
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
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C1292856
- UMLS CUI [1,3]
- C2946261
Beschrijving
Percent of maximum device output
Datatype
float
Maateenheden
- % of device output
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C0699733
- UMLS CUI [1,3]
- C1709366
Beschrijving
Peak to peak MEP size
Datatype
float
Maateenheden
- 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])