ID

34640

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 is for documentation of the transcranial magnetic stimulation (TMS). TMS assessment to be performed in triplicate. The measurements are to be performed within 10 minutes of each other. It should be filled out at the screening visit and each treatment period. 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 (3)
  1. 03-12-18 03-12-18 -
  2. 21-01-19 21-01-19 -
  3. 25-01-19 25-01-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

21 januari 2019

DOI

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

Engels

TMS Form

1 Formulieren  
  1. StudyEvent: ODM
    1. TMS Form
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 of Assessment
Beschrijving

Date of Assessment

Datatype

date

Alias
UMLS CUI [1]
C2985720
Study Visit
Beschrijving

Study Visit

Datatype

text

Transcranial Magnetic Stimulation
Beschrijving

Transcranial Magnetic Stimulation

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

Actual Time

Datatype

time

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

TMS Before Study

Datatype

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?
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]
C0436548
Rest Transcranial Magnetic Stimulation
Beschrijving

Rest Transcranial Magnetic Stimulation

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

Protocol Time

Datatype

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2348563
Study Day
Beschrijving

Study Day

Datatype

text

Assessment
Beschrijving

Assessment

Datatype

integer

Alias
UMLS CUI [1]
C0199171
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Motor Threshold
Beschrijving

Motor Threshold

Datatype

integer

Maateenheden
  • %
Alias
UMLS CUI [1,1]
C0026606
UMLS CUI [1,2]
C0449864
%
Resting TMS assessment completed?
Beschrijving

If No, comment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C0205197
Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Active Transcranial Magnetic Stimulation
Beschrijving

Active Transcranial Magnetic Stimulation

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

Protocol Time

Datatype

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2348563
Study Day
Beschrijving

Study Day

Datatype

text

Assessment
Beschrijving

Assessment

Datatype

integer

Alias
UMLS CUI [1]
C0199171
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Motor Threshold
Beschrijving

Motor Threshold

Datatype

integer

Maateenheden
  • %
Alias
UMLS CUI [1,1]
C0026606
UMLS CUI [1,2]
C0449864
%
Resting TMS assessment completed?
Beschrijving

If No, comment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C0205197
Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Conclusion
Beschrijving

Conclusion

Alias
UMLS CUI-1
C1707478
Assessor Number
Beschrijving

Assessor Number

Datatype

integer

Alias
UMLS CUI [1,1]
C1552089
UMLS CUI [1,2]
C0600091
TMS Machine Number
Beschrijving

TMS Machine Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0436548
UMLS CUI [1,2]
C0336779
UMLS CUI [1,3]
C0600091
Neurophysiologist Staff Initials
Beschrijving

Neurophysiologist Staff Initials

Datatype

text

Alias
UMLS CUI [1,1]
C1552089
UMLS CUI [1,2]
C2986440
UMLS CUI [1,3]
C0586861
Staff initials
Beschrijving

Staff initials

Datatype

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
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Similar models

TMS Form

1 Formulieren
  1. StudyEvent: ODM
    1. TMS Form
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 of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Study Visit
text
Study Visit
Code List
Study Visit
CL Item
Screening Visit (Screening Visit)
CL Item
Treatment Period 1 (Treatment Period 1)
CL Item
Treatment Period 2 (Treatment Period 2)
CL Item
Treatment Period 3 (Treatment Period 3)
Item Group
Transcranial Magnetic Stimulation
C0013806 (UMLS CUI-1)
C0436548 (UMLS CUI-2)
Actual Time
Item
Actual Time
time
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
Rest Transcranial Magnetic Stimulation
C0013806 (UMLS CUI-1)
C0436548 (UMLS CUI-2)
Item
Protocol Time
text
C0040223 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Protocol Time
Code List
Protocol Time
CL Item
Pre Dose (Pre Dose)
CL Item
1h00 post dose (1h00 post dose)
CL Item
2h00 post dose (2h00 post dose)
CL Item
4h00 post dose (4h00 post dose)
CL Item
6h00 post dose (6h00 post dose)
CL Item
24h00 post dose (24h00 post dose)
CL Item
144h00 post dose (144h00 post dose)
Item
Study Day
text
Study Day
Code List
Study Day
CL Item
Day 1 (Day 1)
CL Item
Day 2 (Day 2)
CL Item
Day 7 (Day 7)
Item
Assessment
integer
C0199171 (UMLS CUI [1])
Assessment
Code List
Assessment
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Motor Threshold
Item
Motor Threshold
integer
C0026606 (UMLS CUI [1,1])
C0449864 (UMLS CUI [1,2])
Assessment Completed
Item
Resting TMS assessment completed?
boolean
C0199171 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Active Transcranial Magnetic Stimulation
C0013806 (UMLS CUI-1)
C0436548 (UMLS CUI-2)
Item
Protocol Time
text
C0040223 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Protocol Time
Code List
Protocol Time
CL Item
Pre Dose (Pre Dose)
CL Item
1h00 post dose (1h00 post dose)
CL Item
2h00 post dose (2h00 post dose)
CL Item
4h00 post dose (4h00 post dose)
CL Item
6h00 post dose (6h00 post dose)
CL Item
24h00 post dose (24h00 post dose)
CL Item
144h00 post dose (144h00 post dose)
Item
Study Day
text
Study Day
Code List
Study Day
CL Item
Day 1 (Day 1)
CL Item
Day 2 (Day 2)
CL Item
Day 7 (Day 7)
Item
Assessment
integer
C0199171 (UMLS CUI [1])
Assessment
Code List
Assessment
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Motor Threshold
Item
Motor Threshold
integer
C0026606 (UMLS CUI [1,1])
C0449864 (UMLS CUI [1,2])
Assessment Completed
Item
Resting TMS assessment completed?
boolean
C0199171 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Assessor Number
Item
Assessor Number
integer
C1552089 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
TMS Machine Number
Item
TMS Machine Number
integer
C0436548 (UMLS CUI [1,1])
C0336779 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Neurophysiologist Staff Initials
Item
Neurophysiologist Staff Initials
text
C1552089 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C0586861 (UMLS CUI [1,3])
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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