ID
38023
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-09-09 2019-09-09 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
9 september 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123)
Eligibility Criteria
- StudyEvent: ODM
Beskrivning
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beskrivning
Patients <15kg on VPA are to be excluded
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
Childbearing Potential | Pregnant During the Study | Contraceptive methods
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C3828490
- UMLS CUI [3]
- C0700589
Beskrivning
Seizures | Drop Attack | Epilepsy, Atonic | Epilepsy, Tonic | Myoclonic Epilepsy | Tonic - clonic seizures
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0036572
- UMLS CUI [2]
- C0259813
- UMLS CUI [3]
- C0086236
- UMLS CUI [4]
- C0086241
- UMLS CUI [5]
- C0014550
- UMLS CUI [6]
- C0494475
Beskrivning
Was the age of onset of epilepsy < 11 years?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0206132
Beskrivning
Does the patient have observable seizures occuring at least every alternate day (or a similar average frequency).
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1285626
- UMLS CUI [2]
- C0558287
- UMLS CUI [3]
- C0439603
Beskrivning
Electroencephalogram abnormal | Background; Abnormality | electroencephalogram spike and slow waves; Abnormality | Abnormality; Brain; Focal | Abnormality; Brain; Unifocal | Child
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151611
- UMLS CUI [2,1]
- C1706907
- UMLS CUI [2,2]
- C1704258
- UMLS CUI [3,1]
- C2206302
- UMLS CUI [3,2]
- C1704258
- UMLS CUI [4,1]
- C1704258
- UMLS CUI [4,2]
- C0006104
- UMLS CUI [4,3]
- C0205234
- UMLS CUI [5,1]
- C1704258
- UMLS CUI [5,2]
- C0006104
- UMLS CUI [5,3]
- C0443337
- UMLS CUI [6]
- C0008059
Beskrivning
Mental impairment | Mental deterioration | Normal intellectual function | Intellectual impairment, mild | Development; Evaluation | Intelligence quotient
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0683322
- UMLS CUI [2]
- C0234985
- UMLS CUI [3]
- C3553690
- UMLS CUI [4]
- C1836523
- UMLS CUI [5,1]
- C1527148
- UMLS CUI [5,2]
- C0220825
- UMLS CUI [6]
- C0456149
Beskrivning
Has the patient's antiepileptic medication dosing remained unchanged for one month before screen?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C3174092
- UMLS CUI [1,3]
- C0442739
Beskrivning
Are the patient and carer (parent or guardian) likely to comply with all study procedures?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1321605
Beskrivning
Has the carer (parent or guardian) given written informed consent?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
Is the patient suffering from any severe known organic disease e.g renal or hepatic impairment, which may interfere with drug evaluation?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0683324
- UMLS CUI [1,2]
- C0205082
- UMLS CUI [2]
- C1565489
- UMLS CUI [3]
- C0948807
- UMLS CUI [4,1]
- C0013175
- UMLS CUI [4,2]
- C0521102
Beskrivning
Neurodegenerative Disorders; Progressive | Lysosomal Storage Diseases | Neuronal Ceroid-Lipofuscinoses | Electrophysiological Processes; Evaluation procedure | Diagnostic service - neuroradiology lab | Metabolic; Evaluation procedure
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0524851
- UMLS CUI [1,2]
- C0205329
- UMLS CUI [2]
- C0085078
- UMLS CUI [3]
- C0027877
- UMLS CUI [4,1]
- C2350528
- UMLS CUI [4,2]
- C1261322
- UMLS CUI [5]
- C2183225
- UMLS CUI [6,1]
- C0311400
- UMLS CUI [6,2]
- C1261322
Beskrivning
Additional emergency use of supplementary benzodiazepines is acceptable.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C1265611
Beskrivning
Has the patient been previously exposed to lamotrigine?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0064636
- UMLS CUI [1,2]
- C0205156
Beskrivning
Has the patient been treated with an investigational (unmarketed) drug within 3 months before screen?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C0332152
Beskrivning
Has the patient had more than 2 episodes of major tonic-clonic status epilepticus in any one of the past 6 months?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0038220
- UMLS CUI [1,2]
- C0014549
Similar models
Eligibility Criteria
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C3828490 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0259813 (UMLS CUI [2])
C0086236 (UMLS CUI [3])
C0086241 (UMLS CUI [4])
C0014550 (UMLS CUI [5])
C0494475 (UMLS CUI [6])
C0558287 (UMLS CUI [2])
C0439603 (UMLS CUI [3])
C1706907 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C2206302 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
C1704258 (UMLS CUI [4,1])
C0006104 (UMLS CUI [4,2])
C0205234 (UMLS CUI [4,3])
C1704258 (UMLS CUI [5,1])
C0006104 (UMLS CUI [5,2])
C0443337 (UMLS CUI [5,3])
C0008059 (UMLS CUI [6])
C0234985 (UMLS CUI [2])
C3553690 (UMLS CUI [3])
C1836523 (UMLS CUI [4])
C1527148 (UMLS CUI [5,1])
C0220825 (UMLS CUI [5,2])
C0456149 (UMLS CUI [6])
C3174092 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2])
C0948807 (UMLS CUI [3])
C0013175 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0205329 (UMLS CUI [1,2])
C0085078 (UMLS CUI [2])
C0027877 (UMLS CUI [3])
C2350528 (UMLS CUI [4,1])
C1261322 (UMLS CUI [4,2])
C2183225 (UMLS CUI [5])
C0311400 (UMLS CUI [6,1])
C1261322 (UMLS CUI [6,2])
C1265611 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C0014549 (UMLS CUI [1,2])