ID

34732

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 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 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

Stichworte

Versionen (3)
  1. 03.12.18 03.12.18 -
  2. 21.01.19 21.01.19 -
  3. 25.01.19 25.01.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

25. Januar 2019

DOI

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

Englisch

TMS Form (Treatment Periods)

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

Rest Transcranial Magnetic Stimulation
Beschreibung

Rest Transcranial Magnetic Stimulation

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

Protocol Time

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
Assessment
Beschreibung

Assessment

Datentyp

integer

Alias
UMLS CUI [1]
C0199171
Actual Time
Beschreibung

Actual Time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Motor Threshold
Beschreibung

Motor Threshold

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0026606
UMLS CUI [1,2]
C0449864
%
Resting TMS assessment completed?
Beschreibung

If No, comment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205197
UMLS CUI [1,2]
C0436548
UMLS CUI [1,3]
C0035253
Comments
Beschreibung

Comments

Datentyp

text

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

Active Transcranial Magnetic Stimulation

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

Protocol Time

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
Assessment
Beschreibung

Assessment

Datentyp

integer

Alias
UMLS CUI [1]
C0199171
Actual Time
Beschreibung

Actual Time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Motor Threshold
Beschreibung

Motor Threshold

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0026606
UMLS CUI [1,2]
C0449864
%
Active TMS assessment completed?
Beschreibung

If No, comment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205197
UMLS CUI [1,2]
C0436548
UMLS CUI [1,3]
C0205177
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Conclusion
Beschreibung

Conclusion

Alias
UMLS CUI-1
C1707478
Protocol Time
Beschreibung

Protocol Time

Datentyp

text

Alias
UMLS CUI [1]
C0439564
Assessor Number
Beschreibung

Assessor Number

Datentyp

integer

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

TMS Machine Number

Datentyp

integer

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

Neurophysiologist Staff Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C1552089
UMLS CUI [1,2]
C2986440
UMLS CUI [1,3]
C0586861
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Ähnliche Modelle

TMS Form (Treatment Periods)

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
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)
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)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
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])
Resting TMS Completed
Item
Resting TMS assessment completed?
boolean
C0205197 (UMLS CUI [1,1])
C0436548 (UMLS CUI [1,2])
C0035253 (UMLS CUI [1,3])
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)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
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])
Active TMS Completed
Item
Active TMS assessment completed?
boolean
C0205197 (UMLS CUI [1,1])
C0436548 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,3])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Item
Protocol Time
text
C0439564 (UMLS CUI [1])
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)
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])
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