ID

33529

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 contains informations about the subjects diagnostic EEG results. It should be filled out at the 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

Keywords

Versions (3)
  1. 12/1/18 12/1/18 -
  2. 12/11/18 12/11/18 -
  3. 12/11/18 12/11/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 11, 2018

DOI

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License

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

English

EEG

1 forms  
  1. StudyEvent: ODM
    1. EEG
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Description

Subject Screening No.

Data type

integer

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

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Diagnostic EEG
Description

Diagnostic EEG

Alias
UMLS CUI-1
C0013819
Actual Time
Description

Actual Time

Data type

datetime

Alias
UMLS CUI [1]
C0040223
EEG Comments
Description

EEG Comments

Data type

text

Alias
UMLS CUI [1,1]
C0013819
UMLS CUI [1,2]
C0947611
EEG Performed By
Description

Neurophysiologist Staff Initials

Data type

text

Alias
UMLS CUI [1,1]
C0013819
UMLS CUI [1,2]
C1550369
Clinical Interpretation of EEG
Description

Clinical Interpretation of EEG

Alias
UMLS CUI-1
C4086187
UMLS CUI-2
C0013819
Is the EEG recording normal?
Description

EEG Recording Normal

Data type

boolean

Alias
UMLS CUI [1]
C0560017
If No, is the abnormality clinically significant?
Description

EEG Abnormality Clinically Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0013819
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2985739
If the EEG recording is abnormal and the abnormality is clinically significant, please comment below and exclude the subject from the trial.
Description

EEG Abnormality Comment

Data type

text

Alias
UMLS CUI [1,1]
C0013819
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0947611
Conclusion
Description

Conclusion

Alias
UMLS CUI-1
C1707478
Neurophysiologist Staff initials
Description

Neurophysiologist Staff initials

Data type

text

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

EEG

1 forms
  1. StudyEvent: ODM
    1. EEG
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Diagnostic EEG
C0013819 (UMLS CUI-1)
Actual Time
Item
Actual Time
datetime
C0040223 (UMLS CUI [1])
EEG Comments
Item
EEG Comments
text
C0013819 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
EEG Performed By
Item
EEG Performed By
text
C0013819 (UMLS CUI [1,1])
C1550369 (UMLS CUI [1,2])
Item Group
Clinical Interpretation of EEG
C4086187 (UMLS CUI-1)
C0013819 (UMLS CUI-2)
EEG Recording Normal
Item
Is the EEG recording normal?
boolean
C0560017 (UMLS CUI [1])
EEG Abnormality Clinically Significant
Item
If No, is the abnormality clinically significant?
boolean
C0013819 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
EEG Abnormality Comment
Item
If the EEG recording is abnormal and the abnormality is clinically significant, please comment below and exclude the subject from the trial.
text
C0013819 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Neurophysiologist Staff initials
Item
Neurophysiologist Staff initials
text
C1552089 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C0586861 (UMLS CUI [1,3])
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