ID
38258
Descripción
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
Palabras clave
Versiones (2)
- 5/10/19 5/10/19 -
- 11/10/19 11/10/19 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
5 de octubre de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Sensory nerve testing
Alias
- UMLS CUI-1
- C0027788
- UMLS CUI-2
- C0039593
- UMLS CUI-3
- C0445254
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
Descripción
Please fill in the following items for each nerve and at each measurement.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0027740
- UMLS CUI [1,2]
- C0445254
- UMLS CUI [1,3]
- C0027788
- UMLS CUI [1,4]
- C0039593
Descripción
Please note the amplitude or tick item "Amplitude not tested".
Tipo de datos
float
Unidades de medida
- Microvolts
Alias
- UMLS CUI [1,1]
- C2346753
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C0039593
Descripción
Amplitude not tested
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2346753
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C3640292
Descripción
Please note the Conduction Velocity or tick "not done" in the item "No testing".
Tipo de datos
float
Unidades de medida
- Meters per second
Alias
- UMLS CUI [1,1]
- C0445254
- UMLS CUI [1,2]
- C0429381
Descripción
Conduction velocity not tested
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0436191
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C3640292
Descripción
Please note the Sensory Action Potential or tick the item "Sensory Action Potential not tested".
Tipo de datos
float
Unidades de medida
- Microvolts
Alias
- UMLS CUI [1]
- C0457380
Descripción
Sensory action potential not tested
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0457380
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C3640292
Descripción
Nerve impression
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0027740
- UMLS CUI [1,2]
- C1998467
Descripción
Abnormal nerve impression, reason
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0027740
- UMLS CUI [1,3]
- C1998467
- UMLS CUI [1,4]
- C0566251
Descripción
Motor nerve testing
Alias
- UMLS CUI-1
- C0027788
- UMLS CUI-2
- C0039593
- UMLS CUI-3
- C0234130
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
Descripción
Please fill in the following items for each nerve and at each measurement.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0027740
- UMLS CUI [1,2]
- C0234130
- UMLS CUI [1,3]
- C0027788
- UMLS CUI [1,4]
- C0039593
Descripción
Please note the amplitude or tick the item "Amplitude not tested".
Tipo de datos
float
Unidades de medida
- Millivolts
Alias
- UMLS CUI [1,1]
- C0429340
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0234130
- UMLS CUI [1,4]
- C0039593
Descripción
Amplitude not tested
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2346753
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C3640292
Descripción
Please note the Conduction Velocity or tick the item "Conduction velocity not tested".
Tipo de datos
float
Unidades de medida
- Meters per second
Alias
- UMLS CUI [1,1]
- C0234130
- UMLS CUI [1,2]
- C0429381
Descripción
Conduction velocity not tested
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0436191
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C3640292
Descripción
Nerve impression
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0234130
- UMLS CUI [1,2]
- C0027740
- UMLS CUI [1,3]
- C1998467
Descripción
Abnormal nerve impression, reason
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0027740
- 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])
C0445254 (UMLS CUI [1,2])
C0027788 (UMLS CUI [1,3])
C0039593 (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])
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])
C0234130 (UMLS CUI [1,2])
C0027788 (UMLS CUI [1,3])
C0039593 (UMLS CUI [1,4])
C0027788 (UMLS CUI [1,2])
C0234130 (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])
C0027740 (UMLS CUI [1,2])
C1998467 (UMLS CUI [1,3])
C0027740 (UMLS CUI [1,2])
C1998467 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])