ID
38252
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 Gait Velocity, the Berg Balance Scale and the Fugl-Meyer motor score Form. It has to be filled in for Week 1, Week 4, Week 16 and in case of early withdrawal. It also can be filled in unscheduled. The Gait Velocity and the Berg Balance Scale also has to be filled in for Week 8, Week 12.
Lien
https://clinicaltrials.gov/ct2/show/NCT00833989
Mots-clés
Versions (1)
- 04/10/2019 04/10/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
4 octobre 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989
Gait Velocity, Berg Balance Scale, Fugl-Meyer motor score
- StudyEvent: ODM
Description
Exclusion Criteria
Alias
- UMLS CUI
- C0680251
Description
Ductal carcinoma in situ | Carcinoma, Lobular
Type de données
boolean
Alias
- UMLS CUI [1]
- C0007124
- UMLS CUI [2]
- C0206692
Description
Extensive Intraductal Component Percentage | Ductal Carcinoma In Situ with Microinvasion
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1882485
- UMLS CUI [1,2]
- C0439165
- UMLS CUI [2]
- C2732473
Description
Comorbidity Serious | Condition Excludes Protocol Compliance | Disease Excludes Protocol Compliance | Mental disorders | Addictive Behavior
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0205404
- UMLS CUI [2,1]
- C0348080
- UMLS CUI [2,2]
- C0332196
- UMLS CUI [2,3]
- C0525058
- UMLS CUI [3,1]
- C0012634
- UMLS CUI [3,2]
- C0332196
- UMLS CUI [3,3]
- C0525058
- UMLS CUI [4]
- C0004936
- UMLS CUI [5]
- C0085281
Description
Pregnancy | Breast Feeding | Contraceptive Device as needed
Type de données
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
- UMLS CUI [3,1]
- C0009886
- UMLS CUI [3,2]
- C1555334
Description
Collagen-vascular disease
Type de données
boolean
Alias
- UMLS CUI [1]
- C0262428
Similar models
Gait Velocity, Berg Balance Scale, Fugl-Meyer motor score
- StudyEvent: ODM
C0206692 (UMLS CUI [2])
C0439165 (UMLS CUI [1,2])
C2732473 (UMLS CUI [2])
C0205404 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4])
C0085281 (UMLS CUI [5])
C0006147 (UMLS CUI [2])
C0009886 (UMLS CUI [3,1])
C1555334 (UMLS CUI [3,2])
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