ID

34671

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 is for documentation of the neurological examination. 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

Stichworte

Versionen (6)
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  5. 25.01.19 25.01.19 - Sarah Riepenhausen
  6. 25.01.19 25.01.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

22. Januar 2019

DOI

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Lizenz

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

Englisch

Neurological Examination Form (Visit)

1 Formulare  
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
Study Visit
Beschreibung

Study Visit

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Neurological Examination
Beschreibung

Neurological Examination

Alias
UMLS CUI-1
C0027853
Protocol Time
Beschreibung

Only applies to the follow up visit

Datentyp

text

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

Study Day

Datentyp

text

Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Actual Time
Beschreibung

Actual Time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Has a neurological examination been performed?
Beschreibung

If no, please comment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0884358
Comment
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Does the Subject show symptoms of dizzines?
Beschreibung

Dizzines

Datentyp

boolean

Alias
UMLS CUI [1]
C0012833
Does the Subject show symptoms of vertigo?
Beschreibung

Vertigo

Datentyp

boolean

Alias
UMLS CUI [1]
C0042571
Does the Subject show symptoms of diplopia?
Beschreibung

Diplopia

Datentyp

boolean

Alias
UMLS CUI [1]
C0012569
Does the Subject show symptoms of nystagmus?
Beschreibung

Nystagmus

Datentyp

boolean

Alias
UMLS CUI [1]
C0028738
Has the subject experienced any involuntary muscle twitching?
Beschreibung

If yes, perform a full neurological examination (complete Neurological Examination page) and complete the subject’s Adverse Event source document book.

Datentyp

boolean

Alias
UMLS CUI [1]
C0221722
Physician's Signature
Beschreibung

Physician's Signature

Datentyp

text

Alias
UMLS CUI [1]
C1519316
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
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
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Ähnliche Modelle

Neurological Examination Form (Visit)

1 Formulare
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])
Item
Study Visit
text
C0545082 (UMLS CUI [1])
Study Visit
Code List
Study 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)
CL Item
Follow-Up Visit (Follow-Up Visit)
Item Group
Neurological Examination
C0027853 (UMLS CUI-1)
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
1h30 (1h30)
CL Item
48h00 post dose (48h00 post dose)
Item
Study Day
text
Study Day
Code List
Study Day
CL Item
Day 1 (Day 1)
CL Item
Day 3 (Day 3)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Neurological Examination Performed
Item
Has a neurological examination been performed?
boolean
C0027853 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Dizzines
Item
Does the Subject show symptoms of dizzines?
boolean
C0012833 (UMLS CUI [1])
Vertigo
Item
Does the Subject show symptoms of vertigo?
boolean
C0042571 (UMLS CUI [1])
Diplopia
Item
Does the Subject show symptoms of diplopia?
boolean
C0012569 (UMLS CUI [1])
Nystagmus
Item
Does the Subject show symptoms of nystagmus?
boolean
C0028738 (UMLS CUI [1])
Involuntary Muscle Twitching
Item
Has the subject experienced any involuntary muscle twitching?
boolean
C0221722 (UMLS CUI [1])
Physician's Signature
Item
Physician's Signature
text
C1519316 (UMLS CUI [1])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
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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