ID

34729

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 neurological examination. It should be filled out at each treatment period visit and the follow up 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 (6)
  1. 12/3/18 12/3/18 -
  2. 1/22/19 1/22/19 -
  3. 1/22/19 1/22/19 -
  4. 1/22/19 1/22/19 -
  5. 1/25/19 1/25/19 - Sarah Riepenhausen
  6. 1/25/19 1/25/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

January 25, 2019

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

Neurological Examination Form (Treatment period, Follow-up)

1 forms  
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
Study Visit
Description

Study Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
Neurological Examination
Description

Neurological Examination

Alias
UMLS CUI-1
C0027853
Protocol Time
Description

Only applies to the treatment period visits

Data type

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2348563
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Actual Time
Description

Actual Time

Data type

time

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

If no, please comment

Data type

boolean

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

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Does the subject display any signs/symptoms suggestive of cerebellar dysfunction? Dizziness
Description

Dizziness

Data type

boolean

Alias
UMLS CUI [1]
C0012833
UMLS CUI [2]
C0007760
Does the subject display any signs/symptoms suggestive of cerebellar dysfunction? vertigo
Description

Vertigo

Data type

boolean

Alias
UMLS CUI [1]
C0042571
UMLS CUI [2]
C0007760
Does the subject display any signs/symptoms suggestive of cerebellar dysfunction? Diplopia
Description

Diplopia

Data type

boolean

Alias
UMLS CUI [1]
C0012569
UMLS CUI [2]
C0007760
Does the subject display any signs/symptoms suggestive of cerebellar dysfunction? Nystagmus
Description

Nystagmus

Data type

boolean

Alias
UMLS CUI [1]
C0028738
UMLS CUI [2]
C0007760
Has the subject experienced any involuntary muscle twitching?
Description

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

Data type

boolean

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

Physician's Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
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Similar models

Neurological Examination Form (Treatment period, Follow-up)

1 forms
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])
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
Day 1 1h30 post dose (Day 1 1h30 post dose)
CL Item
Day 3 48h00 post dose (Day 3 48h00 post dose)
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])
Dizziness
Item
Does the subject display any signs/symptoms suggestive of cerebellar dysfunction? Dizziness
boolean
C0012833 (UMLS CUI [1])
C0007760 (UMLS CUI [2])
Vertigo
Item
Does the subject display any signs/symptoms suggestive of cerebellar dysfunction? vertigo
boolean
C0042571 (UMLS CUI [1])
C0007760 (UMLS CUI [2])
Diplopia
Item
Does the subject display any signs/symptoms suggestive of cerebellar dysfunction? Diplopia
boolean
C0012569 (UMLS CUI [1])
C0007760 (UMLS CUI [2])
Nystagmus
Item
Does the subject display any signs/symptoms suggestive of cerebellar dysfunction? Nystagmus
boolean
C0028738 (UMLS CUI [1])
C0007760 (UMLS CUI [2])
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])
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