ID

43501

Descripción

ODM derived from http://clinicaltrials.gov/show/NCT00883051

Link

http://clinicaltrials.gov/show/NCT00883051

Palabras clave

Versiones (3)
  1. 9/12/13 9/12/13 - Martin Dugas
  2. 17/4/14 17/4/14 - Julian Varghese
  3. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility NCT00883051 Migraine Disorders

Alemán Inglés

Eligibility

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Descripción

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter 18 bis 65 Jahre
Descripción

age 18 Years to 65 Years

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004)
Descripción

Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004)

Tipo de datos

boolean

Alias
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
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0154723
SNOMED CT 2011_0131
4473006
MedDRA 14.1
10027607
ICD-10-CM Version 2010
G43.1
UMLS CUI 2011AA
C0338480
SNOMED CT 2011_0131
56097005
MedDRA 14.1
10052787
ICD-10-CM Version 2010
G43.0
ICD-9-CM Version 2011
346.1
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C1512888
UMLS CUI 2011AA
C0018681
SNOMED CT 2011_0131
25064002
MedDRA 14.1
10019211
LOINC Version 232
MTHU020860
ICD-10-CM Version 2010
R51
ICD-9-CM Version 2011
784.0
CTCAE 1105E
E12678
UMLS CUI 2011AA
C0037459
UMLS CUI 2011AA
C0679228
History of migraine of at least 1 year
Descripción

History of migraine of at least 1 year

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
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
Migraine onset before the age of 50 years
Descripción

Migraine onset before the age of 50 years

Tipo de datos

boolean

Alias
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
C0332162
SNOMED CT 2011_0131
77374008
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
History of 1 - 8 migraine attacks per month
Descripción

History of 1 - 8 migraine attacks per month

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
CL415096
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
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
C1304680
SNOMED CT 2011_0131
216299002
UMLS CUI 2011AA
C0332177
SNOMED CT 2011_0131
259036001
Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner)
Descripción

Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner)

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0457572
SNOMED CT 2011_0131
268458002
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0036899
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
UMLS CUI 2011AA
C0420842
SNOMED CT 2011_0131
268457007
Able and willing to give written informed consent
Descripción

Able and willing to give written informed consent

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0021430
Able and willing to complete a migraine diary card to record details of the attack treated with study medication
Descripción

Able and willing to complete a migraine diary card to record details of the attack treated with study medication

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
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
C0376660
Ausschlusskriterien
Descripción

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
History of life threatening or intolerable adverse reaction to any triptan
Descripción

History of life threatening or intolerable adverse reaction to any triptan

Tipo de datos

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
Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation
Descripción

Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation

Tipo de datos

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
Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
Descripción

Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis

Tipo de datos

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
Using 5-HT reuptake inhibitors
Descripción

Using 5-HT reuptake inhibitors

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C2911696
Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
Descripción

Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C2962191
Pregnant or breast-feeding women
Descripción

Pregnant or breast-feeding women

Tipo de datos

boolean

Alias
UMLS CUI 1
C0549206
MedDRA 14.1
10036586
UMLS CUI 2
C0006147
MedDRA 14.1
10006247
Women of child-bearing potential not using highly effective contraception
Descripción

Women of child-bearing potential not using highly effective contraception

Tipo de datos

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
History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
Descripción

History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures

Tipo de datos

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
History of hypertension (controlled or uncontrolled)
Descripción

History of hypertension (controlled or uncontrolled)

Tipo de datos

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
History of orthostatic hypotension
Descripción

History of orthostatic hypotension

Tipo de datos

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
Current use of hemodynamically active cardiovascular drugs
Descripción

Current use of hemodynamically active cardiovascular drugs

Tipo de datos

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
History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
Descripción

History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0237123
Significant renal or hepatic impairment
Descripción

Significant renal or hepatic impairment

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1565489
SNOMED CT 2011_0131
236423003
MedDRA 14.1
10062237
UMLS CUI 2011AA
C0948807
MedDRA 14.1
10052254
Previous participation in this clinical trial
Descripción

Previous participation in this clinical trial

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C2348568
Participation in any clinical trial of an experimental drug or device in the previous 30 days
Descripción

Participation in any clinical trial of an experimental drug or device in the previous 30 days

Tipo de datos

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
Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
Descripción

Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study

Tipo de datos

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
Known Hepatitis B or C or HIV infection
Descripción

Known Hepatitis B or C or HIV infection

Tipo de datos

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
Patients who are employees of the sponsor
Descripción

Patients who are employees of the sponsor

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0599987
SNOMED CT 2011_0131
224528001
UMLS CUI 2011AA
C2347796
Relatives of, or staff directly reporting to, the investigator
Descripción

Relatives of, or staff directly reporting to, the investigator

Tipo de datos

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
Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product
Descripción

Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product

Tipo de datos

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
Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)
Descripción

Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)

Tipo de datos

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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Similar models

Eligibility

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
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)
Item Group
Ausschlusskriterien
CL425201 (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)
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