ID
38345
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 Nerve Conduction Testing Form. It has to be filled in at Week 1, Week 4 and in case of early withdrawal. It also can be filled in unscheduled.
Link
https://clinicaltrials.gov/ct2/show/NCT00833989
Trefwoorden
Versies (2)
- 05-10-19 05-10-19 -
- 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
Nerve Conduction Testing
- StudyEvent: ODM
Beschrijving
Sensory nerve testing
Alias
- UMLS CUI-1
- C0027788
- UMLS CUI-2
- C0039593
- UMLS CUI-3
- C0445254
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
Beschrijving
Please fill in the following items for each nerve and at each measurement.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0445254
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
- UMLS CUI [1,4]
- C0027740
Beschrijving
Please note the amplitude or tick item "Amplitude not tested".
Datatype
float
Maateenheden
- Microvolts
Alias
- UMLS CUI [1,1]
- C2346753
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C0039593
Beschrijving
Sensory Amplitude not tested
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2346753
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C3640292
Beschrijving
Please note the Conduction Velocity or tick "not done" in the item "No testing".
Datatype
float
Maateenheden
- Meters per second
Alias
- UMLS CUI [1,1]
- C0445254
- UMLS CUI [1,2]
- C0429381
Beschrijving
Sensory Conduction velocity not tested
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0436191
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C3640292
Beschrijving
Please note the Sensory Action Potential or tick the item "Sensory Action Potential not tested".
Datatype
float
Maateenheden
- Microvolts
Alias
- UMLS CUI [1]
- C0457380
Beschrijving
Sensory action potential not tested
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0457380
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C3640292
Beschrijving
Sensory Nerve impression
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0027740
- UMLS CUI [1,2]
- C1998467
Beschrijving
if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0027740
- UMLS CUI [1,3]
- C1998467
- UMLS CUI [1,4]
- C0566251
Beschrijving
Motor nerve testing
Alias
- UMLS CUI-1
- C0027788
- UMLS CUI-2
- C0039593
- UMLS CUI-3
- C0234130
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
Beschrijving
Please fill in the following items for each nerve and at each measurement.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0501384
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
Beschrijving
Please note the amplitude or tick the item "Amplitude not tested".
Datatype
float
Maateenheden
- Millivolts
Alias
- UMLS CUI [1,1]
- C0429340
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0501384
- UMLS CUI [1,4]
- C0039593
Beschrijving
Motor Amplitude not tested
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2346753
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0501384
- UMLS CUI [1,4]
- C3640292
Beschrijving
Please note the Conduction Velocity or tick the item "Conduction velocity not tested".
Datatype
float
Maateenheden
- Meters per second
Alias
- UMLS CUI [1,1]
- C0501384
- UMLS CUI [1,2]
- C0429381
Beschrijving
Motor Conduction velocity not tested
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0436191
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0501384
- UMLS CUI [1,4]
- C3640292
Beschrijving
Motor Nerve impression
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0501384
- UMLS CUI [1,2]
- C1998467
Beschrijving
if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0501384
- UMLS CUI [1,3]
- C1998467
- UMLS CUI [1,4]
- C0566251
Similar models
Nerve Conduction Testing
- StudyEvent: ODM
C0039593 (UMLS CUI-2)
C0445254 (UMLS CUI-3)
C0027788 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C0027788 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C0027740 (UMLS CUI [1,4])
C0027788 (UMLS CUI [1,2])
C0445254 (UMLS CUI [1,3])
C0039593 (UMLS CUI [1,4])
C0027788 (UMLS CUI [1,2])
C0445254 (UMLS CUI [1,3])
C3640292 (UMLS CUI [1,4])
C0429381 (UMLS CUI [1,2])
C0027788 (UMLS CUI [1,2])
C0445254 (UMLS CUI [1,3])
C3640292 (UMLS CUI [1,4])
C0027788 (UMLS CUI [1,2])
C0445254 (UMLS CUI [1,3])
C3640292 (UMLS CUI [1,4])
C1998467 (UMLS CUI [1,2])
C0027740 (UMLS CUI [1,2])
C1998467 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0039593 (UMLS CUI-2)
C0234130 (UMLS CUI-3)
C0027788 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C0027788 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C0027788 (UMLS CUI [1,2])
C0501384 (UMLS CUI [1,3])
C0039593 (UMLS CUI [1,4])
C0027788 (UMLS CUI [1,2])
C0501384 (UMLS CUI [1,3])
C3640292 (UMLS CUI [1,4])
C0429381 (UMLS CUI [1,2])
C0027788 (UMLS CUI [1,2])
C0501384 (UMLS CUI [1,3])
C3640292 (UMLS CUI [1,4])
C1998467 (UMLS CUI [1,2])
C0501384 (UMLS CUI [1,2])
C1998467 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])