ID

33217

Beschrijving

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains informations concerning transcranial magnetic stimulation of the subject. It should be filled out at screening visit. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Trefwoorden

Versies (2)
  1. 01-12-18 01-12-18 -
  2. 11-12-18 11-12-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

1 december 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold

Engels

TMS

1 Formulieren  
  1. StudyEvent: ODM
    1. TMS
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschrijving

Subject Screening No.

Datatype

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Beschrijving

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Date Information Collected
Beschrijving

Date Information Collected

Datatype

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
Transcranial Magnetic Stimulation
Beschrijving

Transcranial Magnetic Stimulation

Alias
UMLS CUI-1
C0013806
UMLS CUI-2
C0436548
Actual Time
Beschrijving

Actual Time

Datatype

datetime

Alias
UMLS CUI [1]
C0040223
Has the pre-study TMS been performed?
Beschrijving

TMS Before Study

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013806
UMLS CUI [1,2]
C0436548
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0008976
Does the subject fully understand the TMS procedure and is willing to proceed with the study?
Beschrijving

Subject Understands TMS Procedure and is Willing to Proceed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1273102
UMLS CUI [1,2]
C0436548
UMLS CUI [2]
C0525058
TMS Comments
Beschrijving

TMS Comments

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0013806
UMLS CUI [1,3]
C0436548
Conclusion
Beschrijving

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beschrijving

Staff initials

Datatype

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
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Similar models

TMS

1 Formulieren
  1. StudyEvent: ODM
    1. TMS
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Date Information Collected
Item
Date Information Collected
date
C3244127 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Transcranial Magnetic Stimulation
C0013806 (UMLS CUI-1)
C0436548 (UMLS CUI-2)
Actual Time
Item
Actual Time
datetime
C0040223 (UMLS CUI [1])
TMS Before Study
Item
Has the pre-study TMS been performed?
boolean
C0013806 (UMLS CUI [1,1])
C0436548 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Subject Understands TMS Procedure and is Willing to Proceed
Item
Does the subject fully understand the TMS procedure and is willing to proceed with the study?
boolean
C1273102 (UMLS CUI [1,1])
C0436548 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
TMS Comments
Item
TMS Comments
text
C0947611 (UMLS CUI [1,1])
C0013806 (UMLS CUI [1,2])
C0436548 (UMLS CUI [1,3])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Terug naar het begin van de pagina 

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