ID
3710
Description
ODM derived from http://clinicaltrials.gov/show/NCT01243177
Link
http://clinicaltrials.gov/show/NCT01243177
Keywords
Versions (2)
- 2/22/13 2/22/13 - Martin Dugas
- 9/20/21 9/20/21 -
Uploaded on
February 22, 2013
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT01243177 Epilepsy
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
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)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0036572 (Seizures)
- SNOMED
- 91175000
- LOINC
- LA15899-0
- SNOMED CT 2011_0131
- 91175000 (undefined)
- MedDRA 14.1
- 10039910 (undefined)
- ICD-9-CM Version 2011
- 780.39 (undefined)
- UMLS CUI 2011AA
- C0456387 (Class)
- SNOMED
- 277046005
- SNOMED CT 2011_0131
- 277046005 (undefined)
- UMLS CUI 2011AA
- C0450344 (alphanumeric label - 1A)
- SNOMED
- 264653008
- LOINC
- LA19241-1
- SNOMED CT 2011_0131
- 264653008 (undefined)
- UMLS CUI 2011AA
- C0450345 (1B)
- SNOMED
- 264654002
- LOINC
- LA19242-9
- SNOMED CT 2011_0131
- 264654002 (undefined)
- UMLS CUI 2011AA
- C0205447 (One)
- SNOMED
- 38112003
- SNOMED CT 2011_0131
- 38112003 (undefined)
- UMLS CUI 2011AA
- C0439106 (Upper case Roman letter C)
- SNOMED
- 257962003
- SNOMED CT 2011_0131
- 257962003 (undefined)
- UMLS CUI 2011AA
- C0014550 (Myoclonic Epilepsy)
- SNOMED CT 2011_0131
- 37356005 (undefined)
- MedDRA 14.1
- 10054859 (undefined)
- UMLS CUI 2011AA
- C0014553 (Absence Epilepsy)
- SNOMED
- 432241000124101
- SNOMED CT 2011_0131
- 79631006 (undefined)
- MedDRA 14.1
- 10000332 (undefined)
- ICD-10-CM Version 2010
- G40.3 (undefined)
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
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0036572 (Seizures)
- SNOMED
- 91175000
- LOINC
- LA15899-0
- SNOMED CT 2011_0131
- 91175000 (undefined)
- MedDRA 14.1
- 10039910 (undefined)
- ICD-9-CM Version 2011
- 780.39 (undefined)
- UMLS CUI 2011AA
- CL382928 (undefined)
- UMLS CUI 2011AA
- C0449774 (Patterns)
- SNOMED
- 272135003
- SNOMED CT 2011_0131
- 272135003 (undefined)
- UMLS CUI 2011AA
- C1806781 (Short)
- SNOMED
- 367450005
- LOINC
- LA19631-3
- SNOMED CT 2011_0131
- 367450005 (undefined)
- UMLS CUI 2011AA
- C0439582 (undefined)
- SNOMED CT 2011_0131
- 272117007 (undefined)
Description
Subject has a history, clinical, or Electroencephalogram (EEG) finding suggestive of idiopathic generalized epilepsy (IGE) at randomization
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0013819 (Electroencephalography)
- SNOMED
- 54550000
- LOINC
- LP6239-0
- SNOMED CT 2011_0131
- 54550000 (undefined)
- MedDRA 14.1
- 10014407 (undefined)
- ICD-9-CM Version 2011
- 89.14 (undefined)
- UMLS CUI 2011AA
- C0038659 (therapeutic suggestion)
- UMLS CUI 2011AA
- C0270850 (Idiopathic generalized epilepsy)
- SNOMED
- 36803009
- SNOMED CT 2011_0131
- 36803009 (undefined)
- MedDRA 14.1
- 10071081 (undefined)
- ICD-10-CM Version 2010
- G40.3 (undefined)
Description
Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events which could be confused with seizures
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0011900 (Diagnosis)
- SNOMED
- 439401001
- LOINC
- LP30831-9
- SNOMED CT 2011_0131
- 439401001 (undefined)
- LOINC Version 232
- MTHU008876 (undefined)
- UMLS CUI 2011AA
- C0349245 (Dissociative convulsions)
- SNOMED
- 191714002
- SNOMED CT 2011_0131
- 191714002 (undefined)
- MedDRA 14.1
- 10037148 (undefined)
- ICD-10-CM Version 2010
- F44.5 (undefined)
- UMLS CUI 2011AA
- C0009946 (Conversion disorder)
- SNOMED
- 20734000
- SNOMED CT 2011_0131
- 20734000 (undefined)
- MedDRA 14.1
- 10010893 (undefined)
- ICD-10-CM Version 2010
- F44 (undefined)
- ICD-9-CM Version 2011
- 300.11 (undefined)
- UMLS CUI 2011AA
- C2674681 (Nonepileptic tonic attacks)
- UMLS CUI 2011AA
- C0521102 (Interferes with)
- SNOMED
- 78235001
- SNOMED CT 2011_0131
- 78235001 (undefined)
- UMLS CUI 2011AA
- C0036572 (Seizures)
- SNOMED
- 91175000
- LOINC
- LA15899-0
- SNOMED CT 2011_0131
- 91175000 (undefined)
- MedDRA 14.1
- 10039910 (undefined)
- ICD-9-CM Version 2011
- 780.39 (undefined)
Description
Subject has any medical or psychiatric condition
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1699700 (medical condition category)
- HL7 V3 2006_05
- MEDCCAT (undefined)
- UMLS CUI 2011AA
- C0809986 (Other mental conditions)
Description
Subject has a history of suicide attempt, has received professional counselling for suicidal ideation, or is currently experiencing active suicidal ideation
Data type
boolean
Alias
- UMLS CUI 2011AA
- C2911479 (Personal history of suicide attempt)
- ICD-10-CM Version 2010
- Z91.5 (undefined)
- UMLS CUI 2011AA
- C0010210 (Counseling)
- SNOMED
- 129441002
- SNOMED CT 2011_0131
- 409063005 (undefined)
- UMLS CUI 2011AA
- C0424000 (Feeling suicidal (finding))
- SNOMED
- 6471006
- LOINC
- LA6394-6
- SNOMED CT 2011_0131
- 6471006 (undefined)
- MedDRA 14.1
- 10042458 (undefined)
- ICD-9-CM Version 2011
- V62.84 (undefined)
- CTCAE 1105E
- E12964 (undefined)
- UMLS CUI 2011AA
- CL430050 (undefined)
- MedDRA 14.1
- 10071456 (undefined)
Description
Prior use of felbamate or vigabatrin is not allowed
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1554075 (InclusionNotMandatory <Not permitted>)
- HL7 V3 2006_05
- NP (undefined)
- UMLS CUI 2011AA
- C0332152 (Before)
- SNOMED
- 236874000
- SNOMED CT 2011_0131
- 288556008 (undefined)
- UMLS CUI 2011AA
- C1524063 (Use of)
- SNOMED
- 260676000
- SNOMED CT 2011_0131
- 260676000 (undefined)
- UMLS CUI 2011AA
- C0060135 (felbamate)
- SNOMED
- 371387009
- SNOMED CT 2011_0131
- 371387009 (undefined)
- LOINC Version 232
- MTHU015105 (undefined)
- UMLS CUI 2011AA
- C0048044 (vigabatrin)
- SNOMED
- 310283001
- SNOMED CT 2011_0131
- 322976008 (undefined)
- LOINC Version 232
- MTHU012453 (undefined)
Description
Subject has received treatment with phenobarbital or primidone within 28 days prior to Visit 1
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0039798 (therapeutic aspects)
- UMLS CUI 2011AA
- C0031412 (phenobarbital)
- SNOMED
- 51073002
- SNOMED CT 2011_0131
- 51073002 (undefined)
- LOINC Version 232
- MTHU003431 (undefined)
- UMLS CUI 2011AA
- C0033148 (primidone)
- SNOMED
- 47120002
- SNOMED CT 2011_0131
- 47120002 (undefined)
- LOINC Version 232
- MTHU003369 (undefined)
- UMLS CUI 2011AA
- C0439231 (month)
- SNOMED
- 258706009
- SNOMED CT 2011_0131
- 258706009 (undefined)
- HL7 V3 2006_05
- MO (undefined)
- UMLS CUI 2011AA
- C0332152 (Before)
- SNOMED
- 236874000
- SNOMED CT 2011_0131
- 288556008 (undefined)
- UMLS CUI 2011AA
- C1554196 (undefined)
- HL7 V3 2006_05
- ENC (undefined)
- UMLS CUI 2011AA
- C0205447 (One)
- SNOMED
- 38112003
- SNOMED CT 2011_0131
- 38112003 (undefined)
Description
Subject is taking benzodiazepines for a nonepilepsy indication
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1512806 (Intake)
- UMLS CUI 2011AA
- C0005064 (Benzodiazepines)
- LOINC
- LP15014-1
- SNOMED CT 2011_0131
- 16047007 (undefined)
- LOINC Version 232
- MTHU001123 (undefined)
- UMLS CUI 2011AA
- C1518422 (Negation)
- LOINC
- LA21291-2
- UMLS CUI 2011AA
- C0014544 (Epilepsy)
- SNOMED
- 84757009
- LOINC
- MTHU020586
- SNOMED CT 2011_0131
- 84757009 (undefined)
- MedDRA 14.1
- 10015037 (undefined)
- LOINC Version 232
- MTHU020586 (undefined)
- ICD-10-CM Version 2010
- G40.9 (undefined)
- ICD-9-CM Version 2011
- 345.9 (undefined)
- UMLS CUI 2011AA
- CL335836 (undefined)
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)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0005064 (Benzodiazepines)
- LOINC
- LP15014-1
- SNOMED CT 2011_0131
- 16047007 (undefined)
- LOINC Version 232
- MTHU001123 (undefined)
- UMLS CUI 2011AA
- C0175673 (Bale out)
- SNOMED
- 25876001
- SNOMED CT 2011_0131
- 25876001 (undefined)
- UMLS CUI 2011AA
- C0039798 (therapeutic aspects)
- UMLS CUI 2011AA
- C0439090 (Less Than or Equal to)
- SNOMED
- 276137008
- SNOMED CT 2011_0131
- 276137008 (undefined)
- HL7 V3 2006_05
- LE (undefined)
- UMLS CUI 2011AA
- C0558293 (Once a week)
- SNOMED
- 225769003
- LOINC
- LA26461-6
- SNOMED CT 2011_0131
- 225769003 (undefined)
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
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL415147 (undefined)
- UMLS CUI 2011AA
- C0014544 (Epilepsy)
- SNOMED
- 84757009
- LOINC
- MTHU020586
- SNOMED CT 2011_0131
- 84757009 (undefined)
- MedDRA 14.1
- 10015037 (undefined)
- LOINC Version 232
- MTHU020586 (undefined)
- ICD-10-CM Version 2010
- G40.9 (undefined)
- ICD-9-CM Version 2011
- 345.9 (undefined)
- UMLS CUI 2011AA
- C0003299 (Antiepileptic Agents)
- SNOMED CT 2011_0131
- 255632006 (undefined)
- LOINC Version 232
- MTHU006781 (undefined)
- UMLS CUI 2011AA
- C0005064 (Benzodiazepines)
- LOINC
- LP15014-1
- SNOMED CT 2011_0131
- 16047007 (undefined)
- LOINC Version 232
- MTHU001123 (undefined)
- UMLS CUI 2011AA
- C1517741 (Last)
- LOINC
- LP200101-6
- UMLS CUI 2011AA
- C0205452 (Six)
- SNOMED
- 68244004
- LOINC
- LP20594-5
- SNOMED CT 2011_0131
- 68244004 (undefined)
- UMLS CUI 2011AA
- C0439231 (month)
- SNOMED
- 258706009
- SNOMED CT 2011_0131
- 258706009 (undefined)
- HL7 V3 2006_05
- MO (undefined)
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
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1699700 (medical condition category)
- HL7 V3 2006_05
- MEDCCAT (undefined)
- UMLS CUI 2011AA
- C0521102 (Interferes with)
- SNOMED
- 78235001
- SNOMED CT 2011_0131
- 78235001 (undefined)
- UMLS CUI 2011AA
- C0678745 (drug absorption)
- UMLS CUI 2011AA
- C0699903 (drug distribution (pharmacokinetics))
- UMLS CUI 2011AA
- C0683140 (Drug Metabolism)
- UMLS CUI 2011AA
- C0683141 (drug excretion)
- UMLS CUI 2011AA
- C0221628 (History of alcohol abuse)
- SNOMED
- 371434005
- SNOMED CT 2011_0131
- 371434005 (undefined)
- UMLS CUI 2011AA
- C1299544 (History of substance abuse)
- SNOMED
- 371435006
- SNOMED CT 2011_0131
- 371435006 (undefined)
Description
Asian ancestry and tests positive for HLA-B*1502 allele
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1257906 (Asian Continental Ancestry Group)
- UMLS CUI 2011AA
- C1335447 (Positive Laboratory Test Result)
- UMLS CUI 2011AA
- CL430141 (undefined)
- MedDRA 14.1
- 10071592 (undefined)
- UMLS CUI 2011AA
- C0002085 (Alleles)
- SNOMED
- 9109004
- SNOMED CT 2011_0131
- 9109004 (undefined)
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- StudyEvent: Eligibility
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371435006 (SNOMED CT 2011_0131)
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