ID

33217

Beschreibung

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

Stichworte

Versionen (2)
  1. 01.12.18 01.12.18 -
  2. 11.12.18 11.12.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

1. Dezember 2018

DOI

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

Englisch

TMS

1 Formulare  
  1. StudyEvent: ODM
    1. TMS
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschreibung

Subject Screening No.

Datentyp

integer

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

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date Information Collected
Beschreibung

Date Information Collected

Datentyp

date

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

Transcranial Magnetic Stimulation

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

Actual Time

Datentyp

datetime

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

TMS Before Study

Datentyp

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?
Beschreibung

Subject Understands TMS Procedure and is Willing to Proceed

Datentyp

boolean

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

TMS Comments

Datentyp

text

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

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beschreibung

Staff initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
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Ähnliche Modelle

TMS

1 Formulare
  1. StudyEvent: ODM
    1. TMS
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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