ID
38113
Description
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 Study conclusion Form. It has to be filled in for the end of study.
Link
https://clinicaltrials.gov/ct2/show/NCT00833989
Keywords
Versions (2)
- 9/18/19 9/18/19 -
- 10/5/19 10/5/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 18, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, 111539
Study conclusion
- StudyEvent: ODM
Description
Status of treatment blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Description
If you tick yes, complete the following items and the Adverse Event form and/or Investigational Product forms as appropriate.
Data type
text
Alias
- UMLS CUI [1]
- C3897431
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Description
00:00-23:59
Data type
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0040223
Description
Reason blind broken
Data type
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
Description
Other Reason, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C2348235
Description
Investigational Product discontinuation
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0457454
Description
If you tick yes, please complete in the following item the primary reason.
Data type
text
Alias
- UMLS CUI [1,1]
- C0444930
- UMLS CUI [1,2]
- C0304229
Description
Item is not required If you tick "Adverse Event", please record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate
Data type
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0444930
- UMLS CUI [1,3]
- C0304229
Description
Other reason, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C0444930
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C2348235
Description
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0805839
Description
If you tick yes, please complete details in the following items.
Data type
text
Alias
- UMLS CUI [1]
- C2349954
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0679006
- UMLS CUI [1,3]
- C0011008
Description
If you tick " Adverse Event", record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate.
Data type
integer
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Description
Withdrawal, Investigator discretion, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008961
- UMLS CUI [1,4]
- C0022423
- UMLS CUI [1,5]
- C0008961
Description
Death
Alias
- UMLS CUI-1
- C0011065
Description
If you tick no, please enter the date of death and the primary cause of death in the following items.
Data type
text
Alias
- UMLS CUI [1,1]
- C2584946
- UMLS CUI [1,2]
- C2348568
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C1148348
Description
For both causes, please specify in the following item.
Data type
integer
Alias
- UMLS CUI [1]
- C0007465
Description
Cause of death, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0007465
Description
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Description
This is an optional form but is conditional upon females in the trial; This form will be dynamically generated to appear at the End visit if Female is selected on the Demographics form. If Yes, complete the paper Pregnancy Notification form.
Data type
text
Alias
- UMLS CUI [1]
- C3828490
Description
This is an optional form, but is conditional upon males in the trial. This form will be dynamically generated if the male is selected on the Demography form. If Yes, complete the paper Pregnancy Notification form. Check "Not Applicable" if female partner not of childbearing potential or no female partner.
Data type
text
Alias
- UMLS CUI [1,1]
- C0086287
- UMLS CUI [1,2]
- C3887537
- UMLS CUI [1,3]
- C3828490
Similar models
Study conclusion
- StudyEvent: ODM
C2347038 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0457454 (UMLS CUI-2)
C0304229 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C0008961 (UMLS CUI [1,5])
C0007465 (UMLS CUI [1,2])
C3887537 (UMLS CUI [1,2])
C3828490 (UMLS CUI [1,3])