ID

33530

Descripción

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

Palabras clave

Versiones (2)
  1. 1/12/18 1/12/18 -
  2. 11/12/18 11/12/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

11 de diciembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Inglés

TMS

1 formularios  
  1. StudyEvent: ODM
    1. TMS
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Descripción

Subject Screening No.

Tipo de datos

integer

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

Subject Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Date of Assessment
Descripción

Date of Assessment

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
Transcranial Magnetic Stimulation
Descripción

Transcranial Magnetic Stimulation

Alias
UMLS CUI-1
C0436548
Actual Time
Descripción

Actual Time

Tipo de datos

datetime

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

TMS Before Study

Tipo de datos

boolean

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

Subject Understands TMS Procedure and is Willing to Proceed

Tipo de datos

boolean

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

TMS Comments

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0436548
Conclusion
Descripción

Conclusion

Alias
UMLS CUI-1
C1707478
TMS performed by: Neurophysiologist Staff initials
Descripción

Neurophysiologist Staff initials

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1552089
UMLS CUI [1,2]
C2986440
UMLS CUI [1,3]
C0586861
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Similar models

TMS

1 formularios
  1. StudyEvent: ODM
    1. TMS
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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 of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item Group
Transcranial Magnetic Stimulation
C0436548 (UMLS CUI-1)
Actual Time
Item
Actual Time
datetime
C0040223 (UMLS CUI [1])
TMS Before Study
Item
Has the pre-study TMS been performed?
boolean
C0436548 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
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])
C0436548 (UMLS CUI [1,2])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Neurophysiologist Staff initials
Item
TMS performed by: Neurophysiologist Staff initials
text
C1552089 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C0586861 (UMLS CUI [1,3])
Volver a la parte superior de la página 

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