ID
38251
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 eligibility criteria. It has to be filled in at Day 1.
Link
https://clinicaltrials.gov/ct2/show/NCT00833989
Trefwoorden
Versies (3)
- 04-10-19 04-10-19 -
- 24-10-19 24-10-19 - Sarah Riepenhausen
- 20-09-21 20-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
4 oktober 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989
Eligibility Criteria
- StudyEvent: ODM
Beschrijving
Eligibility question
Alias
- UMLS CUI-1
- C1516637
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
WHO definition of stroke (1989): a rapid onset event of vascular origin reflecting a focal disturbance of cerebral function, excluding isolated impairments of higher function, and persisting longer than 24 hours
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0038454
- UMLS CUI [1,3]
- C0043237
Beschrijving
Time of stroke onset was defined as the time at which the subject/relative was first aware of the stroke deficit. For subjects who awoke with deficits, or who were found unconscious, the time of onset was defined as the time at which they were last known to be symptom free
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C0038454
- UMLS CUI [1,3]
- C0449244
Beschrijving
The diameter of the ischemic lesion was >15 mm in any single direction or the volume was >4cc. Note: You have to tick either this item OR the following item ("Radiologically confirmed stroke, intracerebral hemorrhage")
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0043299
- UMLS CUI [1,2]
- C0948008
- UMLS CUI [1,3]
- C0441938
Beschrijving
The Intracerebral Hemorrhage (ICH) score must have been 0-2 and was calculated based on age, Glasgow Coma Scale score and the initial computed tomography (CT) or MRI findings for the index stroke. (Based on Protocol Amendment 4, subjects with ICH were not enrolled in Germany.) Note: You have to tick either this item OR the item before ("Radiologically confirmed stroke, ischemic and supratentorial")
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0043299
- UMLS CUI [1,2]
- C0038454
- UMLS CUI [1,3]
- C2937358
- UMLS CUI [1,4]
- C0441938
- UMLS CUI [1,5]
- C0205125
- UMLS CUI [1,6]
- C1298908
- UMLS CUI [1,7]
- C1517569
- UMLS CUI [1,8]
- C0231448
- UMLS CUI [2,1]
- C0043299
- UMLS CUI [2,2]
- C0038454
- UMLS CUI [2,3]
- C2937358
- UMLS CUI [2,4]
- C0441938
- UMLS CUI [2,5]
- C0205125
- UMLS CUI [2,6]
- C0547040
- UMLS CUI [2,7]
- C1517569
- UMLS CUI [2,8]
- C0231448
Beschrijving
Based on Protocol Amendment 3, a total NIHSS score of 7-21 was used in Canada.
Datatype
boolean
Alias
- UMLS CUI [1]
- C3476804
Beschrijving
Upper and/or lower limb deficit
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3476804
- UMLS CUI [1,2]
- C0003794
- UMLS CUI [1,3]
- C2987487
- UMLS CUI [2,1]
- C3476804
- UMLS CUI [2,2]
- C0023220
- UMLS CUI [2,3]
- C2987487
Beschrijving
Based on Protocol Amendment 4, the upper age range for inclusion was 85 years of age in Germany.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Physical, occupational and speech rehabilitation therapy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0949766
- UMLS CUI [2]
- C0037831
- UMLS CUI [3]
- C1318464
Beschrijving
Both doses of investigational product
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1706086
- UMLS CUI [1,3]
- C0178602
Beschrijving
Informed consent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0030705
- UMLS CUI [2,1]
- C0021430
- UMLS CUI [2,2]
- C1301860
- UMLS CUI [2,3]
- C0030701
Beschrijving
Note: Females of child-bearing potential are also allowed to participate in this study provided they are using a contraceptive method with a failure rate of <1%
Datatype
boolean
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Previous symptomic stroke
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0559159
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C2348568
Beschrijving
Significant disability prior to stroke, rankin score
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0231170
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0038454
- UMLS CUI [1,4]
- C0451405
Beschrijving
Active and uncontrolled depression
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205177
- UMLS CUI [1,2]
- C0011581
- UMLS CUI [1,3]
- C0205318
Beschrijving
defined by a score of 2 or 3 on the NIHSS Level of Consciousness question
Datatype
boolean
Alias
- UMLS CUI [1]
- C0241526
- UMLS CUI [2,1]
- C1298908
- UMLS CUI [2,2]
- C3665546
- UMLS CUI [3]
- C3476804
Beschrijving
Significant aphasia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0003537
- UMLS CUI [1,2]
- C0392760
- UMLS CUI [1,3]
- C1516048
Beschrijving
Peripheral neuropathy
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0231220
- UMLS CUI [1,2]
- C0031117
- UMLS CUI [2]
- C0011882
Beschrijving
Neurological or psychiatric disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0027765
- UMLS CUI [1,2]
- C0392760
- UMLS CUI [1,3]
- C1516048
- UMLS CUI [1,4]
- C0332152
- UMLS CUI [1,5]
- C0008976
- UMLS CUI [1,6]
- C0679823
- UMLS CUI [2,1]
- C0004936
- UMLS CUI [2,2]
- C0392760
- UMLS CUI [2,3]
- C1516048
- UMLS CUI [2,4]
- C0332152
- UMLS CUI [2,5]
- C0008976
- UMLS CUI [2,6]
- C0679823
- UMLS CUI [3]
- C0497327
- UMLS CUI [4]
- C1270972
Beschrijving
Demyelinating disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011303
- UMLS CUI [2]
- C0026769
Beschrijving
Other chronic co-morbid conditions or unstable acute systemic illnesses
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0008679
- UMLS CUI [1,3]
- C0392760
- UMLS CUI [1,4]
- C2826674
- UMLS CUI [1,5]
- C0023671
- UMLS CUI [2,1]
- C0443343
- UMLS CUI [2,2]
- C0205178
- UMLS CUI [2,3]
- C0442893
- UMLS CUI [2,4]
- C0392760
- UMLS CUI [2,5]
- C2826674
- UMLS CUI [2,6]
- C0023671
Beschrijving
Sensitivity to heparin or heparin-induced thrombocytopenia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020517
- UMLS CUI [1,3]
- C0019134
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0272285
Beschrijving
QTcB, uncorrected QT, bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1]
- C1882512
- UMLS CUI [2]
- C1287082
- UMLS CUI [3]
- C0006384
Beschrijving
Contraindication such as: -had metal present, such as hardware or plate on the scalp in the area to which TMS was applied, implanted cardiac pacemaker, implanted prosthetic heart valve, medication pump or line, metallic implant or clip in the head/neck, electrical, mechanical or magnetic implants, neuro-stimulation device, or orthodontic work involving ferromagnetic materials -occupation or activity that could cause accidental lodging of ferromagnetic materials or embedded metal fragments in the head. Subjects could be cleared by a head computed tomography scan. -concomitant use of drugs that substantially lower seizure threshold (e.g., tricyclic antidepressants and neuroleptics) -known history of seizures or epilepsy -brain tumour, recent brain injury (within 5 years) associated with definite loss of consciousness, or any history of brain surgery -other contraindications per local hospital practice
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1301624
- UMLS CUI [1,2]
- C0436548
- UMLS CUI [2,1]
- C0025552
- UMLS CUI [2,2]
- C0460148
- UMLS CUI [2,3]
- C0150312
- UMLS CUI [3,1]
- C0028811
- UMLS CUI [3,2]
- C0016542
- UMLS CUI [3,3]
- C3178787
- UMLS CUI [3,4]
- C1268086
- UMLS CUI [4,1]
- C0441655
- UMLS CUI [4,2]
- C0016542
- UMLS CUI [4,3]
- C3178787
- UMLS CUI [4,4]
- C1268086
- UMLS CUI [5,1]
- C2347852
- UMLS CUI [5,2]
- C0234976
- UMLS CUI [6,1]
- C0262926
- UMLS CUI [6,2]
- C0036572
- UMLS CUI [7,1]
- C0262926
- UMLS CUI [7,2]
- C0014544
- UMLS CUI [8]
- C0006118
- UMLS CUI [9,1]
- C0332665
- UMLS CUI [9,2]
- C0270611
Beschrijving
Contraindication such as: -have metal present, such as implanted cardiac pacemaker, implanted prosthetic heart valve, medication pump or line, metallic implant or clip in the head/neck, electrical, mechanical or magnetic implants, neuro-stimulation device, or orthodontic work involving ferromagnetic materials, permanent tattooed metallic eye-liner -occupation or activity that may cause accidental lodging of ferromagnetic materials or embedded metal fragments in the head. Subjects can be cleared by a head computed tomography scan -claustrophobia -other contraindications per local hospital practice
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1301624
- UMLS CUI [1,2]
- C0024485
- UMLS CUI [2,1]
- C0025552
- UMLS CUI [2,2]
- C0460148
- UMLS CUI [2,3]
- C0150312
- UMLS CUI [3,1]
- C0028811
- UMLS CUI [3,2]
- C0016542
- UMLS CUI [3,3]
- C3178787
- UMLS CUI [3,4]
- C1268086
- UMLS CUI [4,1]
- C0441655
- UMLS CUI [4,2]
- C0016542
- UMLS CUI [4,3]
- C3178787
- UMLS CUI [4,4]
- C1268086
- UMLS CUI [5]
- C0008909
Beschrijving
Participation in other clinical trial
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1517586
- UMLS CUI [1,3]
- C2348568
- UMLS CUI [1,4]
- C0347984
- UMLS CUI [1,5]
- C2926735
- UMLS CUI [1,6]
- C0008976
Beschrijving
Participation in other clinical trial, investigational product
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [1,3]
- C2348568
- UMLS CUI [1,4]
- C0304229
Beschrijving
Sensitivity to investigational product or components thereof
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C1705248
- UMLS CUI [2,3]
- C0304229
- UMLS CUI [3,1]
- C0262926
- UMLS CUI [3,2]
- C0013227
- UMLS CUI [4,1]
- C0205394
- UMLS CUI [4,2]
- C0020517
Beschrijving
Pregnant females
Datatype
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2,1]
- C0042036
- UMLS CUI [2,2]
- C1141639
- UMLS CUI [2,3]
- C1446409
Beschrijving
Lactating females
Datatype
boolean
Alias
- UMLS CUI [1]
- C0006147
Beschrijving
Protocol compliance
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0525058
- UMLS CUI [1,2]
- C1299582
- UMLS CUI [2,1]
- C0525058
- UMLS CUI [2,2]
- C0558080
Similar models
Eligibility Criteria
- StudyEvent: ODM
C0038454 (UMLS CUI [1,2])
C0043237 (UMLS CUI [1,3])
C0038454 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
C0948008 (UMLS CUI [1,2])
C0441938 (UMLS CUI [1,3])
C0038454 (UMLS CUI [1,2])
C2937358 (UMLS CUI [1,3])
C0441938 (UMLS CUI [1,4])
C0205125 (UMLS CUI [1,5])
C1298908 (UMLS CUI [1,6])
C1517569 (UMLS CUI [1,7])
C0231448 (UMLS CUI [1,8])
C0043299 (UMLS CUI [2,1])
C0038454 (UMLS CUI [2,2])
C2937358 (UMLS CUI [2,3])
C0441938 (UMLS CUI [2,4])
C0205125 (UMLS CUI [2,5])
C0547040 (UMLS CUI [2,6])
C1517569 (UMLS CUI [2,7])
C0231448 (UMLS CUI [2,8])
C0003794 (UMLS CUI [1,2])
C2987487 (UMLS CUI [1,3])
C3476804 (UMLS CUI [2,1])
C0023220 (UMLS CUI [2,2])
C2987487 (UMLS CUI [2,3])
C0037831 (UMLS CUI [2])
C1318464 (UMLS CUI [3])
C1706086 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0030705 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1301860 (UMLS CUI [2,2])
C0030701 (UMLS CUI [2,3])
C0559159 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0332152 (UMLS CUI [1,2])
C0038454 (UMLS CUI [1,3])
C0451405 (UMLS CUI [1,4])
C0011581 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C1298908 (UMLS CUI [2,1])
C3665546 (UMLS CUI [2,2])
C3476804 (UMLS CUI [3])
C0392760 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0031117 (UMLS CUI [1,2])
C0011882 (UMLS CUI [2])
C0392760 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
C0679823 (UMLS CUI [1,6])
C0004936 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C0008976 (UMLS CUI [2,5])
C0679823 (UMLS CUI [2,6])
C0497327 (UMLS CUI [3])
C1270972 (UMLS CUI [4])
C0026769 (UMLS CUI [2])
C0008679 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C2826674 (UMLS CUI [1,4])
C0023671 (UMLS CUI [1,5])
C0443343 (UMLS CUI [2,1])
C0205178 (UMLS CUI [2,2])
C0442893 (UMLS CUI [2,3])
C0392760 (UMLS CUI [2,4])
C2826674 (UMLS CUI [2,5])
C0023671 (UMLS CUI [2,6])
C0020517 (UMLS CUI [1,2])
C0019134 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0272285 (UMLS CUI [2,2])
C1287082 (UMLS CUI [2])
C0006384 (UMLS CUI [3])
C0436548 (UMLS CUI [1,2])
C0025552 (UMLS CUI [2,1])
C0460148 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
C0028811 (UMLS CUI [3,1])
C0016542 (UMLS CUI [3,2])
C3178787 (UMLS CUI [3,3])
C1268086 (UMLS CUI [3,4])
C0441655 (UMLS CUI [4,1])
C0016542 (UMLS CUI [4,2])
C3178787 (UMLS CUI [4,3])
C1268086 (UMLS CUI [4,4])
C2347852 (UMLS CUI [5,1])
C0234976 (UMLS CUI [5,2])
C0262926 (UMLS CUI [6,1])
C0036572 (UMLS CUI [6,2])
C0262926 (UMLS CUI [7,1])
C0014544 (UMLS CUI [7,2])
C0006118 (UMLS CUI [8])
C0332665 (UMLS CUI [9,1])
C0270611 (UMLS CUI [9,2])
C0024485 (UMLS CUI [1,2])
C0025552 (UMLS CUI [2,1])
C0460148 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
C0028811 (UMLS CUI [3,1])
C0016542 (UMLS CUI [3,2])
C3178787 (UMLS CUI [3,3])
C1268086 (UMLS CUI [3,4])
C0441655 (UMLS CUI [4,1])
C0016542 (UMLS CUI [4,2])
C3178787 (UMLS CUI [4,3])
C1268086 (UMLS CUI [4,4])
C0008909 (UMLS CUI [5])
C1517586 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2926735 (UMLS CUI [1,5])
C0008976 (UMLS CUI [1,6])
C0332185 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0304229 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0205394 (UMLS CUI [4,1])
C0020517 (UMLS CUI [4,2])
C0042036 (UMLS CUI [2,1])
C1141639 (UMLS CUI [2,2])
C1446409 (UMLS CUI [2,3])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])