ID

33260

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 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

Trefwoorden

Versies (6)
  1. 03-12-18 03-12-18 -
  2. 22-01-19 22-01-19 -
  3. 22-01-19 22-01-19 -
  4. 22-01-19 22-01-19 -
  5. 25-01-19 25-01-19 - Sarah Riepenhausen
  6. 25-01-19 25-01-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

3 december 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Effect of Lamictal on Resting Motor Threshold

Engels

Neurological Examination Form

1 Formulieren  
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
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Neurological Examination
Beschrijving

Neurological Examination

Alias
UMLS CUI-1
C0027853
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

Has a neurological examination been performed?
Beschrijving

If no, please comment

Datatype

boolean

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

Comment

Datatype

text

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

Dizzines

Datatype

boolean

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

Vertigo

Datatype

boolean

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

Diplopia

Datatype

boolean

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

Nystagmus

Datatype

boolean

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

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

Datatype

boolean

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

Physician's Signature

Datatype

text

Alias
UMLS CUI [1]
C1519316
Conclusion
Beschrijving

Conclusion

Alias
UMLS CUI-1
C1707478
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
Terug naar het begin van de pagina

Similar models

Neurological Examination Form

1 Formulieren
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])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
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)
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial