ID

34640

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 the screening visit and each treatment period. 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

Mots-clés

Versions (3)
  1. 03/12/2018 03/12/2018 -
  2. 21/01/2019 21/01/2019 -
  3. 25/01/2019 25/01/2019 - Sarah Riepenhausen
Détendeur de droits

GlaxoSmithKline

Téléchargé le

21 janvier 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Anglais

TMS Form

1 Formulaires  
  1. StudyEvent: ODM
    1. TMS Form
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Description

Subject Screening No.

Type de données

integer

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

Subject Number

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Date of Assessment
Description

Date of Assessment

Type de données

date

Alias
UMLS CUI [1]
C2985720
Study Visit
Description

Study Visit

Type de données

text

Transcranial Magnetic Stimulation
Description

Transcranial Magnetic Stimulation

Alias
UMLS CUI-1
C0013806
UMLS CUI-2
C0436548
Actual Time
Description

Actual Time

Type de données

time

Alias
UMLS CUI [1]
C0040223
Has the pre-study TMS been performed?
Description

TMS Before Study

Type de données

boolean

Alias
UMLS CUI [1,1]
C0436548
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0008976
Does the subject fully understand the TMS procedure and is willing to proceed with the study?
Description

Subject Understands TMS Procedure and is Willing to Proceed

Type de données

boolean

Alias
UMLS CUI [1,1]
C1273102
UMLS CUI [1,2]
C0436548
UMLS CUI [2]
C0525058
TMS Comments
Description

TMS Comments

Type de données

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0436548
Rest Transcranial Magnetic Stimulation
Description

Rest Transcranial Magnetic Stimulation

Alias
UMLS CUI-1
C0013806
UMLS CUI-2
C0436548
Protocol Time
Description

Protocol Time

Type de données

text

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

Study Day

Type de données

text

Assessment
Description

Assessment

Type de données

integer

Alias
UMLS CUI [1]
C0199171
Actual Time
Description

Actual Time

Type de données

time

Alias
UMLS CUI [1]
C0040223
Motor Threshold
Description

Motor Threshold

Type de données

integer

Unités de mesure
  • %
Alias
UMLS CUI [1,1]
C0026606
UMLS CUI [1,2]
C0449864
%
Resting TMS assessment completed?
Description

If No, comment

Type de données

boolean

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C0205197
Comments
Description

Comments

Type de données

text

Alias
UMLS CUI [1]
C0947611
Active Transcranial Magnetic Stimulation
Description

Active Transcranial Magnetic Stimulation

Alias
UMLS CUI-1
C0013806
UMLS CUI-2
C0436548
Protocol Time
Description

Protocol Time

Type de données

text

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

Study Day

Type de données

text

Assessment
Description

Assessment

Type de données

integer

Alias
UMLS CUI [1]
C0199171
Actual Time
Description

Actual Time

Type de données

time

Alias
UMLS CUI [1]
C0040223
Motor Threshold
Description

Motor Threshold

Type de données

integer

Unités de mesure
  • %
Alias
UMLS CUI [1,1]
C0026606
UMLS CUI [1,2]
C0449864
%
Resting TMS assessment completed?
Description

If No, comment

Type de données

boolean

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C0205197
Comments
Description

Comments

Type de données

text

Alias
UMLS CUI [1]
C0947611
Conclusion
Description

Conclusion

Alias
UMLS CUI-1
C1707478
Assessor Number
Description

Assessor Number

Type de données

integer

Alias
UMLS CUI [1,1]
C1552089
UMLS CUI [1,2]
C0600091
TMS Machine Number
Description

TMS Machine Number

Type de données

integer

Alias
UMLS CUI [1,1]
C0436548
UMLS CUI [1,2]
C0336779
UMLS CUI [1,3]
C0600091
Neurophysiologist Staff Initials
Description

Neurophysiologist Staff Initials

Type de données

text

Alias
UMLS CUI [1,1]
C1552089
UMLS CUI [1,2]
C2986440
UMLS CUI [1,3]
C0586861
Staff initials
Description

Staff initials

Type de données

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Date
Description

Date

Type de données

date

Alias
UMLS CUI [1]
C0011008
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Similar models

TMS Form

1 Formulaires
  1. StudyEvent: ODM
    1. TMS Form
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
Study Visit
text
Study Visit
Code List
Study Visit
CL Item
Screening Visit (Screening 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)
Item Group
Transcranial Magnetic Stimulation
C0013806 (UMLS CUI-1)
C0436548 (UMLS CUI-2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
TMS Before Study
Item
Has the pre-study TMS been performed?
boolean
C0436548 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Subject Understands TMS Procedure and is Willing to Proceed
Item
Does the subject fully understand the TMS procedure and is willing to proceed with the study?
boolean
C1273102 (UMLS CUI [1,1])
C0436548 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
TMS Comments
Item
TMS Comments
text
C0947611 (UMLS CUI [1,1])
C0436548 (UMLS CUI [1,2])
Item Group
Rest Transcranial Magnetic Stimulation
C0013806 (UMLS CUI-1)
C0436548 (UMLS CUI-2)
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
1h00 post dose (1h00 post dose)
CL Item
2h00 post dose (2h00 post dose)
CL Item
4h00 post dose (4h00 post dose)
CL Item
6h00 post dose (6h00 post dose)
CL Item
24h00 post dose (24h00 post dose)
CL Item
144h00 post dose (144h00 post dose)
Item
Study Day
text
Study Day
Code List
Study Day
CL Item
Day 1 (Day 1)
CL Item
Day 2 (Day 2)
CL Item
Day 7 (Day 7)
Item
Assessment
integer
C0199171 (UMLS CUI [1])
Assessment
Code List
Assessment
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Motor Threshold
Item
Motor Threshold
integer
C0026606 (UMLS CUI [1,1])
C0449864 (UMLS CUI [1,2])
Assessment Completed
Item
Resting TMS assessment completed?
boolean
C0199171 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Active Transcranial Magnetic Stimulation
C0013806 (UMLS CUI-1)
C0436548 (UMLS CUI-2)
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
1h00 post dose (1h00 post dose)
CL Item
2h00 post dose (2h00 post dose)
CL Item
4h00 post dose (4h00 post dose)
CL Item
6h00 post dose (6h00 post dose)
CL Item
24h00 post dose (24h00 post dose)
CL Item
144h00 post dose (144h00 post dose)
Item
Study Day
text
Study Day
Code List
Study Day
CL Item
Day 1 (Day 1)
CL Item
Day 2 (Day 2)
CL Item
Day 7 (Day 7)
Item
Assessment
integer
C0199171 (UMLS CUI [1])
Assessment
Code List
Assessment
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Motor Threshold
Item
Motor Threshold
integer
C0026606 (UMLS CUI [1,1])
C0449864 (UMLS CUI [1,2])
Assessment Completed
Item
Resting TMS assessment completed?
boolean
C0199171 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Assessor Number
Item
Assessor Number
integer
C1552089 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
TMS Machine Number
Item
TMS Machine Number
integer
C0436548 (UMLS CUI [1,1])
C0336779 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Neurophysiologist Staff Initials
Item
Neurophysiologist Staff Initials
text
C1552089 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C0586861 (UMLS CUI [1,3])
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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