ID

38023

Beschreibung

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

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  1. 09.09.19 09.09.19 -
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GlaxoSmithKline

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9. September 2019

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Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123)

Englisch

Eligibility Criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Patient's Initials
Beschreibung

Patient's Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Patient's trial number
Beschreibung

Patient's trial number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Center number
Beschreibung

Center number

Datentyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Will the patient be aged 3-25 years inclusive, at the start of treatment?
Beschreibung

Patients <15kg on VPA are to be excluded

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Is the patient male, or female and of childbearing potential, who in the judgement of the investigator has no reasonable chance of being/becoming pregnant during the course of the study, based on a review of birth control methods employed and other factors in their gynaecological history?
Beschreibung

Childbearing Potential | Pregnant During the Study | Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C3828490
UMLS CUI [3]
C0700589
Does the patient have more than one predominantly generalised seizure type including drop attacks (atonic, tonic, major myoclonic) and/or tonic-clonic seizures of at least one year duration?
Beschreibung

Seizures | Drop Attack | Epilepsy, Atonic | Epilepsy, Tonic | Myoclonic Epilepsy | Tonic - clonic seizures

Datentyp

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
Was the age of onset of epilepsy < 11 years?
Beschreibung

Was the age of onset of epilepsy < 11 years?

Datentyp

boolean

Alias
UMLS CUI [1]
C0206132
Does the patient have observable seizures occuring at least every alternate day (or a similar average frequency).
Beschreibung

Does the patient have observable seizures occuring at least every alternate day (or a similar average frequency).

Datentyp

boolean

Alias
UMLS CUI [1]
C1285626
UMLS CUI [2]
C0558287
UMLS CUI [3]
C0439603
Does the patient have a recent EEG recording which demonstrates an abnormal background, some slow spike wave abnormality (<2.5Hz) and lacks predominantly focal or unifacal abnormalities, particularly in younger children?
Beschreibung

Electroencephalogram abnormal | Background; Abnormality | electroencephalogram spike and slow waves; Abnormality | Abnormality; Brain; Focal | Abnormality; Brain; Unifocal | Child

Datentyp

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
Does the patient have at least moderate intellectual impairment or is there a cIinicaI impression of intellectual deterioration in those patients with normal intellectual function or mild impairment based on results of developmental assessments or IQ tests as appropriate and feasible?
Beschreibung

Mental impairment | Mental deterioration | Normal intellectual function | Intellectual impairment, mild | Development; Evaluation | Intelligence quotient

Datentyp

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
Has the patient's antiepileptic medication dosing remained unchanged for one month before screen?
Beschreibung

Has the patient's antiepileptic medication dosing remained unchanged for one month before screen?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C3174092
UMLS CUI [1,3]
C0442739
Are the patient and carer (parent or guardian) likely to comply with all study procedures?
Beschreibung

Are the patient and carer (parent or guardian) likely to comply with all study procedures?

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
Has the carer (parent or guardian) given written informed consent?
Beschreibung

Has the carer (parent or guardian) given written informed consent?

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Is the patient suffering from any severe known organic disease e.g renal or hepatic impairment, which may interfere with drug evaluation?
Beschreibung

Is the patient suffering from any severe known organic disease e.g renal or hepatic impairment, which may interfere with drug evaluation?

Datentyp

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
Is the patient suffering from any known definite progressive neurodegenerative disorder e.g. Iysosomal storage disorder, Batten's disease, as established by the appropriate electrophysiological, neuroradiological and metabolic investigations?
Beschreibung

Neurodegenerative Disorders; Progressive | Lysosomal Storage Diseases | Neuronal Ceroid-Lipofuscinoses | Electrophysiological Processes; Evaluation procedure | Diagnostic service - neuroradiology lab | Metabolic; Evaluation procedure

Datentyp

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
Is the patient receiving treatment with more than 2 antiepileptic drugs?
Beschreibung

Additional emergency use of supplementary benzodiazepines is acceptable.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C1265611
Has the patient been previously exposed to lamotrigine?
Beschreibung

Has the patient been previously exposed to lamotrigine?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0064636
UMLS CUI [1,2]
C0205156
Has the patient been treated with an investigational (unmarketed) drug within 3 months before screen?
Beschreibung

Has the patient been treated with an investigational (unmarketed) drug within 3 months before screen?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332152
Has the patient had more than 2 episodes of major tonic-clonic status epilepticus in any one of the past 6 months?
Beschreibung

Has the patient had more than 2 episodes of major tonic-clonic status epilepticus in any one of the past 6 months?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038220
UMLS CUI [1,2]
C0014549
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Ähnliche Modelle

Eligibility Criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient's Initials
Item
Patient's Initials
text
C2986440 (UMLS CUI [1])
Patient's trial number
Item
Patient's trial number
text
C2348585 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Will the patient be aged 3-25 years inclusive, at the start of treatment?
Item
Will the patient be aged 3-25 years inclusive, at the start of treatment?
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential | Pregnant During the Study | Contraceptive methods
Item
Is the patient male, or female and of childbearing potential, who in the judgement of the investigator has no reasonable chance of being/becoming pregnant during the course of the study, based on a review of birth control methods employed and other factors in their gynaecological history?
boolean
C3831118 (UMLS CUI [1])
C3828490 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Seizures | Drop Attack | Epilepsy, Atonic | Epilepsy, Tonic | Myoclonic Epilepsy | Tonic - clonic seizures
Item
Does the patient have more than one predominantly generalised seizure type including drop attacks (atonic, tonic, major myoclonic) and/or tonic-clonic seizures of at least one year duration?
boolean
C0036572 (UMLS CUI [1])
C0259813 (UMLS CUI [2])
C0086236 (UMLS CUI [3])
C0086241 (UMLS CUI [4])
C0014550 (UMLS CUI [5])
C0494475 (UMLS CUI [6])
Was the age of onset of epilepsy < 11 years?
Item
Was the age of onset of epilepsy < 11 years?
boolean
C0206132 (UMLS CUI [1])
Does the patient have observable seizures occuring at least every alternate day (or a similar average frequency).
Item
Does the patient have observable seizures occuring at least every alternate day (or a similar average frequency).
boolean
C1285626 (UMLS CUI [1])
C0558287 (UMLS CUI [2])
C0439603 (UMLS CUI [3])
Electroencephalogram abnormal | Background; Abnormality | electroencephalogram spike and slow waves; Abnormality | Abnormality; Brain; Focal | Abnormality; Brain; Unifocal | Child
Item
Does the patient have a recent EEG recording which demonstrates an abnormal background, some slow spike wave abnormality (<2.5Hz) and lacks predominantly focal or unifacal abnormalities, particularly in younger children?
boolean
C0151611 (UMLS CUI [1])
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])
Mental impairment | Mental deterioration | Normal intellectual function | Intellectual impairment, mild | Development; Evaluation | Intelligence quotient
Item
Does the patient have at least moderate intellectual impairment or is there a cIinicaI impression of intellectual deterioration in those patients with normal intellectual function or mild impairment based on results of developmental assessments or IQ tests as appropriate and feasible?
boolean
C0683322 (UMLS CUI [1])
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])
Has the patient's antiepileptic medication dosing remained unchanged for one month before screen?
Item
Has the patient's antiepileptic medication dosing remained unchanged for one month before screen?
boolean
C0003299 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Are the patient and carer (parent or guardian) likely to comply with all study procedures?
Item
Are the patient and carer (parent or guardian) likely to comply with all study procedures?
boolean
C1321605 (UMLS CUI [1])
Has the carer (parent or guardian) given written informed consent?
Item
Has the carer (parent or guardian) given written informed consent?
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Is the patient suffering from any severe known organic disease e.g renal or hepatic impairment, which may interfere with drug evaluation?
Item
Is the patient suffering from any severe known organic disease e.g renal or hepatic impairment, which may interfere with drug evaluation?
boolean
C0683324 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2])
C0948807 (UMLS CUI [3])
C0013175 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
Neurodegenerative Disorders; Progressive | Lysosomal Storage Diseases | Neuronal Ceroid-Lipofuscinoses | Electrophysiological Processes; Evaluation procedure | Diagnostic service - neuroradiology lab | Metabolic; Evaluation procedure
Item
Is the patient suffering from any known definite progressive neurodegenerative disorder e.g. Iysosomal storage disorder, Batten's disease, as established by the appropriate electrophysiological, neuroradiological and metabolic investigations?
boolean
C0524851 (UMLS CUI [1,1])
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])
Is the patient receiving treatment with more than 2 antiepileptic drugs?
Item
Is the patient receiving treatment with more than 2 antiepileptic drugs?
boolean
C0003299 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Has the patient been previously exposed to lamotrigine?
Item
Has the patient been previously exposed to lamotrigine?
boolean
C0064636 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Has the patient been treated with an investigational (unmarketed) drug within 3 months before screen?
Item
Has the patient been treated with an investigational (unmarketed) drug within 3 months before screen?
boolean
C0013230 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
Has the patient had more than 2 episodes of major tonic-clonic status epilepticus in any one of the past 6 months?
Item
Has the patient had more than 2 episodes of major tonic-clonic status epilepticus in any one of the past 6 months?
boolean
C0038220 (UMLS CUI [1,1])
C0014549 (UMLS CUI [1,2])
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