ID
38269
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 Unscheduled Assessments form.
Link
https://clinicaltrials.gov/ct2/show/NCT00833989
Trefwoorden
Versies (4)
- 18-09-19 18-09-19 -
- 05-10-19 05-10-19 -
- 24-10-19 24-10-19 - Sarah Riepenhausen
- 24-10-19 24-10-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
5 oktober 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989
Unscheduled Assessments
- StudyEvent: ODM
Beschrijving
Unscheduled Assessments
Alias
- UMLS CUI-1
- C0220825
- UMLS CUI-2
- C3854240
Beschrijving
Vital signs
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0518766
Beschrijving
ECG
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0430456
Beschrijving
MRI
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0024485
Beschrijving
PK
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0031328
Beschrijving
Immunogenicity assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C3898797
Beschrijving
Nerve Conduction assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
Beschrijving
Geriatric Depression assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0451184
Beschrijving
NIH Stroke assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C1697238
Beschrijving
Barthel assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0451019
Beschrijving
Montreal Cognitive assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C3496286
Beschrijving
Gait Velocity assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0016928
- UMLS CUI [1,3]
- C0436191
Beschrijving
Berg-Balance assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C1321053
Beschrijving
Fugl-Meyer assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0234130
- UMLS CUI [1,3]
- C0449820
Beschrijving
Box and Blocks assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0542341
- UMLS CUI [1,2]
- C0039593
- UMLS CUI [2]
- C0565699
Beschrijving
Grip Strength assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0429271
Beschrijving
TMS
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0436548
Similar models
Unscheduled Assessments
- StudyEvent: ODM
C3854240 (UMLS CUI-2)
C0518766 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C3898797 (UMLS CUI [1,2])
C0027788 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C0451184 (UMLS CUI [1,2])
C1697238 (UMLS CUI [1,2])
C0451019 (UMLS CUI [1,2])
C3496286 (UMLS CUI [1,2])
C0016928 (UMLS CUI [1,2])
C0436191 (UMLS CUI [1,3])
C1321053 (UMLS CUI [1,2])
C0234130 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0039593 (UMLS CUI [1,2])
C0565699 (UMLS CUI [2])
C0429271 (UMLS CUI [1,2])