age 18 Years to 65 Years
Item
Alter 18 bis 65 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004)
Item
Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004)
boolean
C0149931 (UMLS CUI 2011AA)
37796009 (SNOMED CT 2011_0131)
10027599 (MedDRA 14.1)
G43 (ICD-10-CM Version 2010)
346 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0154723 (UMLS CUI 2011AA)
4473006 (SNOMED CT 2011_0131)
10027607 (MedDRA 14.1)
G43.1 (ICD-10-CM Version 2010)
C0338480 (UMLS CUI 2011AA)
56097005 (SNOMED CT 2011_0131)
10052787 (MedDRA 14.1)
G43.0 (ICD-10-CM Version 2010)
346.1 (ICD-9-CM Version 2011)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C1512888 (UMLS CUI 2011AA)
C0018681 (UMLS CUI 2011AA)
25064002 (SNOMED CT 2011_0131)
10019211 (MedDRA 14.1)
MTHU020860 (LOINC Version 232)
R51 (ICD-10-CM Version 2010)
784.0 (ICD-9-CM Version 2011)
E12678 (CTCAE 1105E)
C0037459 (UMLS CUI 2011AA)
C0679228 (UMLS CUI 2011AA)
History of migraine of at least 1 year
Item
History of migraine of at least 1 year
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0149931 (UMLS CUI 2011AA)
37796009 (SNOMED CT 2011_0131)
10027599 (MedDRA 14.1)
G43 (ICD-10-CM Version 2010)
346 (ICD-9-CM Version 2011)
Migraine onset before the age of 50 years
Item
Migraine onset before the age of 50 years
boolean
C0149931 (UMLS CUI 2011AA)
37796009 (SNOMED CT 2011_0131)
10027599 (MedDRA 14.1)
G43 (ICD-10-CM Version 2010)
346 (ICD-9-CM Version 2011)
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
History of 1 - 8 migraine attacks per month
Item
History of 1 - 8 migraine attacks per month
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
CL415096 (UMLS CUI 2011AA)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0149931 (UMLS CUI 2011AA)
37796009 (SNOMED CT 2011_0131)
10027599 (MedDRA 14.1)
G43 (ICD-10-CM Version 2010)
346 (ICD-9-CM Version 2011)
C1304680 (UMLS CUI 2011AA)
216299002 (SNOMED CT 2011_0131)
C0332177 (UMLS CUI 2011AA)
259036001 (SNOMED CT 2011_0131)
Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner)
Item
Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner)
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0457572 (UMLS CUI 2011AA)
268458002 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
Able and willing to give written informed consent
Item
Able and willing to give written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Able and willing to complete a migraine diary card to record details of the attack treated with study medication
Item
Able and willing to complete a migraine diary card to record details of the attack treated with study medication
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0149931 (UMLS CUI 2011AA)
37796009 (SNOMED CT 2011_0131)
10027599 (MedDRA 14.1)
G43 (ICD-10-CM Version 2010)
346 (ICD-9-CM Version 2011)
C0376660 (UMLS CUI 2011AA)
History of life threatening or intolerable adverse reaction to any triptan
Item
History of life threatening or intolerable adverse reaction to any triptan
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1744706 (UMLS CUI 2011AA)
C2826244 (UMLS CUI 2011AA)
C0041755 (UMLS CUI 2011AA)
62014003 (SNOMED CT 2011_0131)
10061623 (MedDRA 14.1)
T88.7 (ICD-10-CM Version 2010)
C1567966 (UMLS CUI 2011AA)
Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation
Item
Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation
boolean
C1521941 (UMLS CUI 2011AA)
MTHU034709 (LOINC Version 232)
C0149931 (UMLS CUI 2011AA)
37796009 (SNOMED CT 2011_0131)
10027599 (MedDRA 14.1)
G43 (ICD-10-CM Version 2010)
346 (ICD-9-CM Version 2011)
C0420172 (UMLS CUI 2011AA)
33572000 (SNOMED CT 2011_0131)
Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
Item
Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0949854 (UMLS CUI 2011AA)
C0376266 (UMLS CUI 2011AA)
C0937904 (UMLS CUI 2011AA)
417382006 (SNOMED CT 2011_0131)
C1142085 (UMLS CUI 2011AA)
408381007 (SNOMED CT 2011_0131)
10058734 (MedDRA 14.1)
Using 5-HT reuptake inhibitors
Item
Using 5-HT reuptake inhibitors
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C2911696 (UMLS CUI 2011AA)
Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
Item
Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C2962191 (UMLS CUI 2011AA)
Pregnant or breast-feeding women
Item
Pregnant or breast-feeding women
boolean
C0549206 (UMLS CUI 1)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2)
10006247 (MedDRA 14.1)
Women of child-bearing potential not using highly effective contraception
Item
Women of child-bearing potential not using highly effective contraception
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
Item
History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
boolean
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
C0948008 (UMLS CUI 2011AA)
422504002 (SNOMED CT 2011_0131)
10055221 (MedDRA 14.1)
C0553692 (UMLS CUI 2011AA)
230706003 (SNOMED CT 2011_0131)
10019016 (MedDRA 14.1)
C0014544 (UMLS CUI 2011AA)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
History of hypertension (controlled or uncontrolled)
Item
History of hypertension (controlled or uncontrolled)
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0020538 (UMLS CUI 2011AA)
38341003 (SNOMED CT 2011_0131)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
History of orthostatic hypotension
Item
History of orthostatic hypotension
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0020651 (UMLS CUI 2011AA)
28651003 (SNOMED CT 2011_0131)
10031127 (MedDRA 14.1)
I95.1 (ICD-10-CM Version 2010)
458.0 (ICD-9-CM Version 2011)
Current use of hemodynamically active cardiovascular drugs
Item
Current use of hemodynamically active cardiovascular drugs
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0019010 (UMLS CUI 2011AA)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0007220 (UMLS CUI 2011AA)
14833006 (SNOMED CT 2011_0131)
History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
Item
History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
boolean
C0237123 (UMLS CUI 2011AA)
Significant renal or hepatic impairment
Item
Significant renal or hepatic impairment
boolean
C1565489 (UMLS CUI 2011AA)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
C0948807 (UMLS CUI 2011AA)
10052254 (MedDRA 14.1)
Previous participation in this clinical trial
Item
Previous participation in this clinical trial
boolean
C2348568 (UMLS CUI 2011AA)
Participation in any clinical trial of an experimental drug or device in the previous 30 days
Item
Participation in any clinical trial of an experimental drug or device in the previous 30 days
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
Item
Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0587081 (UMLS CUI 2011AA)
118246004 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1548788 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Known Hepatitis B or C or HIV infection
Item
Known Hepatitis B or C or HIV infection
boolean
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
Patients who are employees of the sponsor
Item
Patients who are employees of the sponsor
boolean
C0599987 (UMLS CUI 2011AA)
224528001 (SNOMED CT 2011_0131)
C2347796 (UMLS CUI 2011AA)
Relatives of, or staff directly reporting to, the investigator
Item
Relatives of, or staff directly reporting to, the investigator
boolean
C0080103 (UMLS CUI 2011AA)
125677006 (SNOMED CT 2011_0131)
C0851286 (UMLS CUI 2011AA)
C0700287 (UMLS CUI 2011AA)
223458004 (SNOMED CT 2011_0131)
MTHU002737 (LOINC Version 232)
CL102947 (UMLS CUI 2011AA)
Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product
Item
Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C2974932 (UMLS CUI 2011AA)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
C0534690 (UMLS CUI 2011AA)
C0243192 (UMLS CUI 2011AA)
Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)
Item
Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C2974932 (UMLS CUI 2011AA)