ID
43274
Description
ODM derived from http://clinicaltrials.gov/show/NCT01243177
Lien
http://clinicaltrials.gov/show/NCT01243177
Mots-clés
Versions (2)
- 22/02/2013 22/02/2013 - Martin Dugas
- 20/09/2021 20/09/2021 -
Téléchargé le
20 septembre 2021
DOI
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Licence
Creative Commons BY 4.0
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Eligibility NCT01243177 Epilepsy
Eligibility
- StudyEvent: Eligibility
Description
Ausschlusskriterien
Description
Subject has a history or presence of seizures of other types than partial-onset (IA, IB, IC with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures (eg, myoclonic, absence)
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0036572
- SNOMED CT 2011_0131
- 91175000
- MedDRA 14.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
- UMLS CUI 2011AA
- C0456387
- SNOMED CT 2011_0131
- 277046005
- UMLS CUI 2011AA
- C0450344
- SNOMED CT 2011_0131
- 264653008
- UMLS CUI 2011AA
- C0450345
- SNOMED CT 2011_0131
- 264654002
- UMLS CUI 2011AA
- C0205447
- SNOMED CT 2011_0131
- 38112003
- UMLS CUI 2011AA
- C0439106
- SNOMED CT 2011_0131
- 257962003
- UMLS CUI 2011AA
- C0014550
- SNOMED CT 2011_0131
- 37356005
- MedDRA 14.1
- 10054859
- UMLS CUI 2011AA
- C0014553
- SNOMED CT 2011_0131
- 79631006
- MedDRA 14.1
- 10000332
- ICD-10-CM Version 2010
- G40.3
Description
Subject has a history or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time (ie, <20 minutes) with or without function regained between 2 ictal events
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0036572
- SNOMED CT 2011_0131
- 91175000
- MedDRA 14.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
- UMLS CUI 2011AA
- CL382928
- UMLS CUI 2011AA
- C0449774
- SNOMED CT 2011_0131
- 272135003
- UMLS CUI 2011AA
- C1806781
- SNOMED CT 2011_0131
- 367450005
- UMLS CUI 2011AA
- C1948053
- SNOMED CT 2011_0131
- 272117007
Description
Subject has a history, clinical, or Electroencephalogram (EEG) finding suggestive of idiopathic generalized epilepsy (IGE) at randomization
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0013819
- SNOMED CT 2011_0131
- 54550000
- MedDRA 14.1
- 10014407
- ICD-9-CM Version 2011
- 89.14
- UMLS CUI 2011AA
- C0038659
- UMLS CUI 2011AA
- C0270850
- SNOMED CT 2011_0131
- 36803009
- MedDRA 14.1
- 10071081
- ICD-10-CM Version 2010
- G40.3
Description
Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events which could be confused with seizures
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0011900
- SNOMED CT 2011_0131
- 439401001
- LOINC Version 232
- MTHU008876
- UMLS CUI 2011AA
- C0349245
- SNOMED CT 2011_0131
- 191714002
- MedDRA 14.1
- 10037148
- ICD-10-CM Version 2010
- F44.5
- UMLS CUI 2011AA
- C0009946
- SNOMED CT 2011_0131
- 20734000
- MedDRA 14.1
- 10010893
- ICD-10-CM Version 2010
- F44
- ICD-9-CM Version 2011
- 300.11
- UMLS CUI 2011AA
- C2674681
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0036572
- SNOMED CT 2011_0131
- 91175000
- MedDRA 14.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
Description
Subject has any medical or psychiatric condition
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0809986
Description
Subject has a history of suicide attempt, has received professional counselling for suicidal ideation, or is currently experiencing active suicidal ideation
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C2911479
- ICD-10-CM Version 2010
- Z91.5
- UMLS CUI 2011AA
- C0010210
- SNOMED CT 2011_0131
- 409063005
- UMLS CUI 2011AA
- C0424000
- SNOMED CT 2011_0131
- 6471006
- MedDRA 14.1
- 10042458
- ICD-9-CM Version 2011
- V62.84
- CTCAE 1105E
- E12964
- UMLS CUI 2011AA
- CL430050
- MedDRA 14.1
- 10071456
Description
Prior use of felbamate or vigabatrin is not allowed
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1554075
- HL7 V3 2006_05
- NP
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0060135
- SNOMED CT 2011_0131
- 371387009
- LOINC Version 232
- MTHU015105
- UMLS CUI 2011AA
- C0048044
- SNOMED CT 2011_0131
- 322976008
- LOINC Version 232
- MTHU012453
Description
Subject has received treatment with phenobarbital or primidone within 28 days prior to Visit 1
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0031412
- SNOMED CT 2011_0131
- 51073002
- LOINC Version 232
- MTHU003431
- UMLS CUI 2011AA
- C0033148
- SNOMED CT 2011_0131
- 47120002
- LOINC Version 232
- MTHU003369
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1512346
- HL7 V3 2006_05
- ENC
- UMLS CUI 2011AA
- C0205447
- SNOMED CT 2011_0131
- 38112003
Description
Subject is taking benzodiazepines for a nonepilepsy indication
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1512806
- UMLS CUI 2011AA
- C0005064
- SNOMED CT 2011_0131
- 16047007
- LOINC Version 232
- MTHU001123
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0014544
- SNOMED CT 2011_0131
- 84757009
- MedDRA 14.1
- 10015037
- LOINC Version 232
- MTHU020586
- ICD-10-CM Version 2010
- G40.9
- ICD-9-CM Version 2011
- 345.9
- UMLS CUI 2011AA
- CL335836
Description
Benzodiazepines as rescue therapy for epilepsy may have been used as needed in this time period, but not more frequently than once per week)
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0005064
- SNOMED CT 2011_0131
- 16047007
- LOINC Version 232
- MTHU001123
- UMLS CUI 2011AA
- C0175673
- SNOMED CT 2011_0131
- 25876001
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0439090
- SNOMED CT 2011_0131
- 276137008
- HL7 V3 2006_05
- LE
- UMLS CUI 2011AA
- C0558293
- SNOMED CT 2011_0131
- 225769003
Description
Subject has been treated for epilepsy with any antiepileptic drug (AED) (including benzodiazepines) in the last 6 months before Visit 1 (however, acute and subacute seizure treatment is accepted with a maximum of 2 weeks duration and if treatment was stopped at least 1 week before Visit 1
Type de données
boolean
Alias
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C0014544
- SNOMED CT 2011_0131
- 84757009
- MedDRA 14.1
- 10015037
- LOINC Version 232
- MTHU020586
- ICD-10-CM Version 2010
- G40.9
- ICD-9-CM Version 2011
- 345.9
- UMLS CUI 2011AA
- C0003299
- SNOMED CT 2011_0131
- 255632006
- LOINC Version 232
- MTHU006781
- UMLS CUI 2011AA
- C0005064
- SNOMED CT 2011_0131
- 16047007
- LOINC Version 232
- MTHU001123
- UMLS CUI 2011AA
- C1517741
- UMLS CUI 2011AA
- C0205452
- SNOMED CT 2011_0131
- 68244004
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
Description
Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion, has a history of alcohol or drug abuse within the previous 2 years
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0678745
- UMLS CUI 2011AA
- C0699903
- UMLS CUI 2011AA
- C0683140
- UMLS CUI 2011AA
- C0683141
- UMLS CUI 2011AA
- C0221628
- SNOMED CT 2011_0131
- 371434005
- UMLS CUI 2011AA
- C1299544
- SNOMED CT 2011_0131
- 371435006
Description
Asian ancestry and tests positive for HLA-B*1502 allele
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1257906
- UMLS CUI 2011AA
- C1335447
- UMLS CUI 2011AA
- CL430141
- MedDRA 14.1
- 10071592
- UMLS CUI 2011AA
- C0002085
- SNOMED CT 2011_0131
- 9109004
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Eligibility
- StudyEvent: Eligibility
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