ID
33259
Description
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 each 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
Keywords
Versions (3)
- 12/3/18 12/3/18 -
- 1/21/19 1/21/19 -
- 1/25/19 1/25/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
December 3, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold
TMS Form
- StudyEvent: ODM
Description
Rest Transcranial Magnetic Stimulation
Alias
- UMLS CUI-1
- C0013806
- UMLS CUI-2
- C0436548
Description
Protocol Time
Data type
text
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2348563
Description
Study Day
Data type
text
Description
Assessment
Data type
integer
Alias
- UMLS CUI [1]
- C0199171
Description
Actual Time
Data type
time
Alias
- UMLS CUI [1]
- C0040223
Description
Motor Threshold
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0026606
- UMLS CUI [1,2]
- C0449864
Description
If No, comment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0205197
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Active Transcranial Magnetic Stimulation
Alias
- UMLS CUI-1
- C0013806
- UMLS CUI-2
- C0436548
Description
Protocol Time
Data type
text
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2348563
Description
Study Day
Data type
text
Description
Assessment
Data type
integer
Alias
- UMLS CUI [1]
- C0199171
Description
Actual Time
Data type
time
Alias
- UMLS CUI [1]
- C0040223
Description
Motor Threshold
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0026606
- UMLS CUI [1,2]
- C0449864
Description
If No, comment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0205197
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Conclusion
Alias
- UMLS CUI-1
- C1707478
Description
Assessor Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1552089
- UMLS CUI [1,2]
- C0600091
Description
TMS Machine Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0436548
- UMLS CUI [1,2]
- C0336779
- UMLS CUI [1,3]
- C0600091
Description
Neurophysiologist Staff Initials
Data type
text
Alias
- UMLS CUI [1,1]
- C1552089
- UMLS CUI [1,2]
- C2986440
- UMLS CUI [1,3]
- C0586861
Description
Staff initials
Data type
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1552089
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Similar models
TMS Form
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0436548 (UMLS CUI-2)
C0449864 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C0436548 (UMLS CUI-2)
C0449864 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0336779 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C2986440 (UMLS CUI [1,2])
C0586861 (UMLS CUI [1,3])
C1552089 (UMLS CUI [1,2])