ID
38345
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 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
Stichworte
Versionen (2)
- 05.10.19 05.10.19 -
- 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
Nerve Conduction Testing
- StudyEvent: ODM
Beschreibung
Sensory nerve testing
Alias
- UMLS CUI-1
- C0027788
- UMLS CUI-2
- C0039593
- UMLS CUI-3
- C0445254
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
Beschreibung
Please fill in the following items for each nerve and at each measurement.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0445254
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
- UMLS CUI [1,4]
- C0027740
Beschreibung
Please note the amplitude or tick item "Amplitude not tested".
Datentyp
float
Maßeinheiten
- Microvolts
Alias
- UMLS CUI [1,1]
- C2346753
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C0039593
Beschreibung
Sensory Amplitude not tested
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2346753
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C3640292
Beschreibung
Please note the Conduction Velocity or tick "not done" in the item "No testing".
Datentyp
float
Maßeinheiten
- Meters per second
Alias
- UMLS CUI [1,1]
- C0445254
- UMLS CUI [1,2]
- C0429381
Beschreibung
Sensory Conduction velocity not tested
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0436191
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C3640292
Beschreibung
Please note the Sensory Action Potential or tick the item "Sensory Action Potential not tested".
Datentyp
float
Maßeinheiten
- Microvolts
Alias
- UMLS CUI [1]
- C0457380
Beschreibung
Sensory action potential not tested
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0457380
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C3640292
Beschreibung
Sensory Nerve impression
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0027740
- UMLS CUI [1,2]
- C1998467
Beschreibung
if applicable
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0027740
- UMLS CUI [1,3]
- C1998467
- UMLS CUI [1,4]
- C0566251
Beschreibung
Motor nerve testing
Alias
- UMLS CUI-1
- C0027788
- UMLS CUI-2
- C0039593
- UMLS CUI-3
- C0234130
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
Beschreibung
Please fill in the following items for each nerve and at each measurement.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0501384
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
Beschreibung
Please note the amplitude or tick the item "Amplitude not tested".
Datentyp
float
Maßeinheiten
- Millivolts
Alias
- UMLS CUI [1,1]
- C0429340
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0501384
- UMLS CUI [1,4]
- C0039593
Beschreibung
Motor Amplitude not tested
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2346753
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0501384
- UMLS CUI [1,4]
- C3640292
Beschreibung
Please note the Conduction Velocity or tick the item "Conduction velocity not tested".
Datentyp
float
Maßeinheiten
- Meters per second
Alias
- UMLS CUI [1,1]
- C0501384
- UMLS CUI [1,2]
- C0429381
Beschreibung
Motor Conduction velocity not tested
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0436191
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0501384
- UMLS CUI [1,4]
- C3640292
Beschreibung
Motor Nerve impression
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0501384
- UMLS CUI [1,2]
- C1998467
Beschreibung
if applicable
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0501384
- UMLS CUI [1,3]
- C1998467
- UMLS CUI [1,4]
- C0566251
Ähnliche Modelle
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])