ID
38052
Description
Study ID: 105-123 Clinical Study ID: 105-123 Study Title: Lamotrigine as add-on therapy in patients with clinical diagnosis of a Lennox-Gastaut syndrome (severe generalised epilepsy of childhood onset.) A multicentre, double-blind, placebo controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Seizures
Keywords
Versions (1)
- 9/12/19 9/12/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 12, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123)
Visit 1 / Screen - Neurological Examination; EEG
- StudyEvent: ODM
Description
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Description
Behaviour
Data type
integer
Alias
- UMLS CUI [1]
- C0004927
Description
Please give brief details.
Data type
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0004927
Description
Vision
Data type
integer
Alias
- UMLS CUI [1]
- C0042789
Description
Please give brief details.
Data type
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0042789
Description
Hearing
Data type
integer
Alias
- UMLS CUI [1]
- C0018767
Description
Please give brief details.
Data type
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0018767
Description
Speech
Data type
integer
Alias
- UMLS CUI [1]
- C0037817
Description
Please give brief details.
Data type
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0037817
Description
Non-verbal Communication
Data type
integer
Alias
- UMLS CUI [1]
- C0558264
Description
Please give brief details.
Data type
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0558264
Description
Cranial Nerves
Data type
integer
Alias
- UMLS CUI [1]
- C0010268
Description
Please give brief details.
Data type
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0010268
Description
Upper limb motor function
Data type
integer
Alias
- UMLS CUI [1,1]
- C0234130
- UMLS CUI [1,2]
- C1140618
Description
Please give brief details.
Data type
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0234130
- UMLS CUI [1,4]
- C1140618
Description
Lower limb motor function
Data type
integer
Alias
- UMLS CUI [1,1]
- C0234130
- UMLS CUI [1,2]
- C0023216
Description
Please give brief details.
Data type
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0234130
- UMLS CUI [1,4]
- C0023216
Description
Gross Co-ordination
Data type
integer
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C0439806
Description
Please give brief details.
Data type
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0242414
- UMLS CUI [1,4]
- C0439806
Description
Fine Co-ordination
Data type
integer
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C0205232
Description
Please give brief details.
Data type
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0242414
- UMLS CUI [1,4]
- C0205232
Description
Please specify.
Data type
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0205394
Description
Other neurological examination
Data type
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0205394
Description
Please give brief details.
Data type
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0205394
Description
Electroencephalography
Alias
- UMLS CUI-1
- C0013819
Description
EEG Recording Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013819
Description
Number of recording channels
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439799
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0013819
Description
If continuous ambulatory.
Data type
durationDatetime
Measurement units
- hrs
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C0013819
Description
Please check one.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1706907
- UMLS CUI [1,2]
- C0026606
- UMLS CUI [1,3]
- C0205246
Description
Sleep - Are approximately 10Hz poly spike and wave discharges present?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0037313
- UMLS CUI [1,2]
- C3806403
Description
Sleep - If approximately 10Hz poly spike and wave discharges are not present, state principal finding.
Data type
text
Alias
- UMLS CUI [1,1]
- C0037313
- UMLS CUI [1,2]
- C3806403
- UMLS CUI [2]
- C0243095
Description
Awake - Are paroxysms of generalised irregular <2.5Hz slow spike wave discharges present?
Data type
boolean
Alias
- UMLS CUI [1]
- C0234422
- UMLS CUI [2,1]
- C0036572
- UMLS CUI [2,2]
- C2206302
- UMLS CUI [2,3]
- C0205246
- UMLS CUI [2,4]
- C0205271
Description
Awake - If paroxysms of generalised irregular <2.5Hz slow spike wave discharges are not present, state principal finding.
Data type
text
Alias
- UMLS CUI [1]
- C0234422
- UMLS CUI [2,1]
- C0036572
- UMLS CUI [2,2]
- C2206302
- UMLS CUI [2,3]
- C0205246
- UMLS CUI [2,4]
- C0205271
- UMLS CUI [3]
- C0243095
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- StudyEvent: ODM
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C0205394 (UMLS CUI [1,2])
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C0013819 (UMLS CUI [1,2])
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C3806403 (UMLS CUI [1,2])
C0243095 (UMLS CUI [2])
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C2206302 (UMLS CUI [2,2])
C0205246 (UMLS CUI [2,3])
C0205271 (UMLS CUI [2,4])
C0036572 (UMLS CUI [2,1])
C2206302 (UMLS CUI [2,2])
C0205246 (UMLS CUI [2,3])
C0205271 (UMLS CUI [2,4])
C0243095 (UMLS CUI [3])