ID
43501
Description
ODM derived from http://clinicaltrials.gov/show/NCT00883051
Link
http://clinicaltrials.gov/show/NCT00883051
Keywords
Versions (3)
- 12/9/13 12/9/13 - Martin Dugas
- 4/17/14 4/17/14 - Julian Varghese
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT00883051 Migraine Disorders
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
History of life threatening or intolerable adverse reaction to any triptan
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C1744706
- UMLS CUI 2011AA
- C2826244
- UMLS CUI 2011AA
- C0041755
- SNOMED CT 2011_0131
- 62014003
- MedDRA 14.1
- 10061623
- ICD-10-CM Version 2010
- T88.7
- UMLS CUI 2011AA
- C1567966
Description
Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1521941
- LOINC Version 232
- MTHU034709
- UMLS CUI 2011AA
- C0149931
- SNOMED CT 2011_0131
- 37796009
- MedDRA 14.1
- 10027599
- ICD-10-CM Version 2010
- G43
- ICD-9-CM Version 2011
- 346
- UMLS CUI 2011AA
- C0420172
- SNOMED CT 2011_0131
- 33572000
Description
Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0949854
- UMLS CUI 2011AA
- C0376266
- UMLS CUI 2011AA
- C0937904
- SNOMED CT 2011_0131
- 417382006
- UMLS CUI 2011AA
- C1142085
- SNOMED CT 2011_0131
- 408381007
- MedDRA 14.1
- 10058734
Description
Using 5-HT reuptake inhibitors
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C2911696
Description
Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C2962191
Description
Pregnant or breast-feeding women
Data type
boolean
Alias
- UMLS CUI 1
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2
- C0006147
- MedDRA 14.1
- 10006247
Description
Women of child-bearing potential not using highly effective contraception
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
- UMLS CUI 2011AA
- C1148523
- UMLS CUI 2011AA
- C0237399
- UMLS CUI 2011AA
- C0420844
- SNOMED CT 2011_0131
- 169450001
Description
History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0010068
- SNOMED CT 2011_0131
- 53741008
- MedDRA 14.1
- 10068617
- UMLS CUI 2011AA
- C0948008
- SNOMED CT 2011_0131
- 422504002
- MedDRA 14.1
- 10055221
- UMLS CUI 2011AA
- C0553692
- SNOMED CT 2011_0131
- 230706003
- MedDRA 14.1
- 10019016
- 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
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C0332167
- SNOMED CT 2011_0131
- 15508007
- UMLS CUI 2011AA
- C0036572
- SNOMED CT 2011_0131
- 91175000
- MedDRA 14.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
Description
History of hypertension (controlled or uncontrolled)
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C2587213
- SNOMED CT 2011_0131
- 31509003
- UMLS CUI 2011AA
- C0020538
- SNOMED CT 2011_0131
- 38341003
- MedDRA 14.1
- 10020772
- LOINC Version 232
- MTHU020789
- ICD-10-CM Version 2010
- I10
- ICD-9-CM Version 2011
- 997.91
- CTCAE 1105E
- E13785
- UMLS CUI 2011AA
- C1868885
- MedDRA 14.1
- 10066860
Description
History of orthostatic hypotension
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0020651
- SNOMED CT 2011_0131
- 28651003
- MedDRA 14.1
- 10031127
- ICD-10-CM Version 2010
- I95.1
- ICD-9-CM Version 2011
- 458.0
Description
Current use of hemodynamically active cardiovascular drugs
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0019010
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0007220
- SNOMED CT 2011_0131
- 14833006
Description
History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0237123
Description
Significant renal or hepatic impairment
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1565489
- SNOMED CT 2011_0131
- 236423003
- MedDRA 14.1
- 10062237
- UMLS CUI 2011AA
- C0948807
- MedDRA 14.1
- 10052254
Description
Previous participation in this clinical trial
Data type
boolean
Alias
- UMLS CUI 2011AA
- C2348568
Description
Participation in any clinical trial of an experimental drug or device in the previous 30 days
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C2346570
Description
Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0587081
- SNOMED CT 2011_0131
- 118246004
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- C1548788
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Description
Known Hepatitis B or C or HIV infection
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0019163
- SNOMED CT 2011_0131
- 66071002
- MedDRA 14.1
- 10019731
- UMLS CUI 2011AA
- C0019196
- SNOMED CT 2011_0131
- 50711007
- MedDRA 14.1
- 10019744
- ICD-10-CM Version 2010
- B19.20
- ICD-9-CM Version 2011
- 070.7
- UMLS CUI 2011AA
- C0019693
- SNOMED CT 2011_0131
- 86406008
- MedDRA 14.1
- 10020161
- LOINC Version 232
- MTHU020829
- ICD-10-CM Version 2010
- B20
- ICD-9-CM Version 2011
- 042
Description
Patients who are employees of the sponsor
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0599987
- SNOMED CT 2011_0131
- 224528001
- UMLS CUI 2011AA
- C2347796
Description
Relatives of, or staff directly reporting to, the investigator
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0080103
- SNOMED CT 2011_0131
- 125677006
- UMLS CUI 2011AA
- C0851286
- UMLS CUI 2011AA
- C0700287
- SNOMED CT 2011_0131
- 223458004
- LOINC Version 232
- MTHU002737
- UMLS CUI 2011AA
- CL102947
Description
Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C2974932
- UMLS CUI 2011AA
- C0015237
- SNOMED CT 2011_0131
- 360215002
- UMLS CUI 2011AA
- C0534690
- UMLS CUI 2011AA
- C0243192
Description
Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
- UMLS CUI 2011AA
- C2974932
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